UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
(Amendment No. 1)
For
the annual period ended:
OR
For the transition period from ___ to ___
Commission
File Number
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of incorporation or organization) |
(IRS Employer Identification No.) |
(Address of principal executive offices) | (Zip code) |
(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
Title of Each Class | Trading Symbol(s) | Name of each exchange on which registered | ||
The
|
Securities registered under section 12(g) of the Act: None
Indicate
by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐
Indicate
by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Exchange Act. Yes ☐
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 (Section 232.405 of this chapter) during the preceding 12 months (or such shorter period that the registrant was
required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act:
Large accelerated filer ☐ | Accelerated filer ☐ |
Smaller
reporting company | |
Emerging
growth company |
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. ☐
Indicate
by check mark whether the registrant has filed a report on and attestation of its management’s assessment of the effectiveness
of its internal controls over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered
public accounting firm that prepared or issued its audit report.
If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements. ☐
Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐
As
of June 30, 2022, the last day of the registrant’s most recently completed second fiscal quarter; the aggregate market value of
the registrant’s common stock held by non-affiliates of the registrant, based on a closing price of $10.72 per share, was approximately
$
As of March 30, 2023, there were shares outstanding of Registrant’s Common Stock (par value $0.01 per share).
DOCUMENTS INCORPORATED BY REFERENCE
None.
EXPLANATORY NOTE
In connection with the filing of this Amendment and pursuant to the rules of the SEC, we are including with this Amendment new certifications by our principal executive and principal financial officers. Accordingly, Item 15 of Part IV has also been amended to reflect the filing of these new certifications.
Accordingly, this Amendment consists of a cover page, this Explanatory Note, a revised Part II, Item 8, an updated Exhibit Index, new consents of the Company’s independent registered public accounting firms and new certifications pursuant to Section 302 and Section 906 of the Sarbanes-Oxley Act of 2002.
This Amendment does not modify, amend or update in any way the financial statements and other disclosures set forth in the Original Filing and there have been no changes to the XBRL data filed in Exhibit 101 of the Original Filing. In addition, this Amendment does not reflect events occurring after the filing of the Original Filing, nor does it modify or update disclosures therein in any way other than as required to reflect the revisions described above. Among other things, forward-looking statements made in the Original Filing have not been revised to reflect events that occurred or facts that became known to us after the filing of the Original Filing, and any such forward looking statements should be read in their historical context. Accordingly, this Amendment should be read in conjunction with the Original Filing.
ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES
FORM 10-K
TABLE OF CONTENTS
Page | ||
EXPLANATORY NOTE | ||
PART II | ||
Item 8. | Financial Statements and Supplementary Data | 2 |
PART IV | ||
Item 15. | Exhibits and Financial Statement Schedules | 2 |
SIGNATURES | 7 |
1 |
PART II
Item 8. Financial Statements and Supplementary Data
The information required by this Item 8 is included at the end of this Annual Report on Form 10-K beginning on page F-1.
PART IV
Item 15. Exhibits and Financial Statement Schedules
The following documents are filed as part of this Annual Report on Form 10-K:
(1) Financial Statements:
Reports
of Independent Registered Accounting Firm (PCAOB Firm ID : Marcum LLP # |
F-1 |
Consolidated Balance Sheets | F-4 |
Consolidated Statements of Operations and Comprehensive Loss | F-5 |
Consolidated Statements of Changes in Temporary Equity and Shareholders’ Equity | F-6 |
Consolidated Statements of Cash Flows | F-8 |
Notes to Consolidated Financial Statements | F-9 |
2 |
(2) Financial Statement Schedules:
None. Financial statement schedules have not been included because they are not applicable, or the information is included in the consolidated financial statements or notes thereto.
(3) Exhibits:
See “Index to Exhibits” for a description of our exhibits.
INDEX TO EXHIBITS
3 |
4 |
5 |
* | Filed herewith. | |
** | Furnished herewith. | |
# | Management contract or compensatory plan or arrangement. |
6 |
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
ENVERIC BIOSCIENCES, INC. | ||
June 8, 2023 | By: | /s/ Joseph Tucker |
Joseph Tucker | ||
Chief Executive Officer | ||
(Principal Executive Officer) |
7 |
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Shareholders and Board of Directors of
Enveric Biosciences, Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheet of Enveric Biosciences, Inc. (the “Company”) as of December 31, 2022, the related consolidated statements operations and comprehensive loss, changes in temporary equity and shareholders’ equity and cash flows for the year ended December 31, 2022, and the related notes (collectively referred to as the “financial statements”). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2022, and the results of its operations and its cash flows for the year ended December 31, 2022, in conformity with accounting principles generally accepted in the United States of America.
We also audited adjustments to the 2021 financial statements to retroactively apply the effects of the reverse stock split as described in Note 1. In our opinion, such adjustments are appropriate and have been properly applied. We were not engaged to audit, review, or apply any procedures to the Company’s 2021 financial statements other than with respect to the reverse stock split adjustments and, accordingly, we do not express an opinion or any other form of assurance on the 2021 financial statements as a whole.
Explanatory Paragraph – Going Concern
The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As more fully described in Note 2, the Company has a significant working capital deficiency, has incurred significant losses and needs to raise additional funds to meet its obligations and sustain its operations. These conditions raise substantial doubt about the Company’s ability to continue as a going concern. Management’s plans in regard to these matters are also described in Note 2. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Basis for Opinion
These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audit. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audit we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our audit included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audit also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audit provides a reasonable basis for our opinion.
F-1 |
Critical Audit Matters
The critical audit matters communicated below are matters arising from the current period audit of the financial statements that were communicated or required to be communicated to the audit committee and that: (1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of critical audit matters does not alter in any way our opinion on the financial statements, taken as a whole, and we are not, by communicating the critical audit matters below, providing separate opinions on the critical audit matters or on the accounts or disclosures to which they relate.
Impairment of Long-lived Assets
Critical Audit Matter Description
|
As discussed in Notes 2 and 4 to the financial statements, the Company reviews goodwill on an annual basis for impairment, or when circumstances indicate the assets might be impaired. Additionally, the Company reviews long lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset or asset group may not be recoverable. Due to a sustained decline in the Company’s market capitalization, the Company performed an impairment analysis and determined that an impairment of goodwill and long-lived assets existed at December 31, 2022.
Auditing the Company’s accounting for impairment of goodwill and long-lived assets required a high degree of subjective auditor judgment in evaluating the estimated discounted future cash flows used to test reporting units for recoverability and the determination of fair value of the relevant assets. The high degree of auditor judgement and increased extent of effort, including the need to involve valuation specialists, was required to evaluate the reasonableness of management’s analysis related to the impairment of goodwill and long-lived assets. | |
How We Addressed the Matter in Our Audit
|
We obtained an understanding and evaluated the procedures over management’s impairment review process. We evaluated the reasonableness of management’s inputs inclusive of forecasts and discount rates used in the impairment analysis. With the assistance of our valuation specialists, we evaluated the reasonableness of the valuation methodology, tested the mathematical accuracy of the calculation and developed a range of independent estimates to determine reasonableness of valuation conclusions. |
Redeemable Non-controlling Interest and Derivative Liability
Critical Audit Matter Description
|
As discussed in Notes 1, 2 and 8 to the financial statements, the Company announced plans to transfer and spin-off its cannabinoid clinical development pipeline assets to Akos Biosciences, Inc. (“Akos”) a majority owned subsidiary of the Company. Akos entered into a Securities Purchase Agreement, pursuant to which Akos agreed to sell to an investor 1,000 shares of Akos’ Series A Convertible Preferred Stock for $1.0 million during the year ended December 31, 2022. If the Spin-Off does not occur, the Company has guaranteed the redeemable non-controlling interest associated with the put right option as defined in the Series A Convertible Preferred Stock agreement. Fees associated with the spin-off including, but not limited to, placement agent fees, are contingent upon the spin-off occurring.
Auditing the accounting conclusions for the issuance of the Series A Convertible Preferred Stock discussed above was challenging because of the complex provisions affecting classification and required extensive audit effort. The accounting for the Series A Convertible Preferred Stock involved an assessment of the particular features in the agreement and Certificate of Designation and the impact of those features on the accounting and classification of the Series A Convertible Preferred Stock. The determination of fair value requires significant judgement by management and third-party valuation specialists to develop significant estimates and assumptions including the probability of the spin off occurring. Auditing management’s judgements involved especially challenging auditor judgement due to the nature and extent of audit effort required. | |
How We Addressed the Matter in Our Audit
|
We obtained an understanding and evaluated the procedures over management’s technical accounting analysis and valuation process. We inspected the governing agreements for the transaction and evaluated the application of the Company’s technical accounting analyses including evaluating the terms and management’s conclusion on the interpretation and application of the relevant accounting literature. With the assistance of our valuation specialists, we evaluated the reasonableness of the valuation methodology used, we evaluated the reasonableness of the inputs subject to assumptions and verified the accuracy and completeness of those inputs to the underlying transaction data utilized in the valuation of the preferred stock and derivative liability; we performed sensitivity analyses of the significant assumptions used in the valuation model to evaluate the change in fair value resulting from changes in the significant assumptions to determine reasonableness of the valuation conclusions. |
/s/
We have served as the Company’s auditor since 2021 (such date takes into account the acquisition of certain assets of Friedman LLP by Marcum LLP effective September 1, 2022).
March 31, 2023
F-2 |
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Stockholders and Board of Directors of Enveric Biosciences, Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheet of Enveric Biosciences, Inc. (the Company) as of December 31, 2021, and the related consolidated statements of operations and comprehensive loss, stockholders’ equity, and cash flows for the year then ended, and the related notes (collectively referred to as the “financial statements”). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2021, and the results of its operations and its cash flows for the year ended December 31, 2021, in conformity with accounting principles generally accepted in the United States of America.
We were not engaged to audit, review or apply any procedures to retroactively apply the effects of the reverse stock split described in Note 1, accordingly, we do not express an opinion or any other form of assurance about whether such adjustments are appropriate and have been properly applied. Those adjustments were audited by Marcum LLP.
Basis for Opinion
These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audit. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audit, we are required to obtain an understanding of internal control over financial reporting, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our audit included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audit also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audit provides a reasonable basis for our opinion.
/s/
| |
We have served as the Company’s auditor from 2021 through 2022. | |
March 31, 2022 |
F-3 |
ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
As of December 31, | ||||||||
2022 | 2021 | |||||||
ASSETS | ||||||||
Current assets: | ||||||||
Cash | $ | $ | ||||||
Prepaid expenses and other current assets | ||||||||
Total current assets | ||||||||
Other assets: | ||||||||
Property and equipment, net | ||||||||
Right-of-use operating lease asset | ||||||||
Intangible assets, net | ||||||||
Goodwill | ||||||||
Total other assets | ||||||||
Total assets | $ | $ | ||||||
LIABILITIES, TEMPORARY EQUITY, AND SHAREHOLDERS’ EQUITY | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | $ | ||||||
Accrued liabilities | ||||||||
Current portion of right-of-use operating lease obligation | ||||||||
Investment option liability | ||||||||
Warrant liability | ||||||||
Derivative liability | ||||||||
Total current liabilities | ||||||||
Non-current liabilities: | ||||||||
Non-current portion of right-of-use operating lease obligation | ||||||||
Deferred tax liability | ||||||||
Total non-current liabilities | ||||||||
Total liabilities | $ | $ | ||||||
Commitments and contingencies (Note 9) | ||||||||
Temporary equity | ||||||||
Series C redeemable preferred stock, $ | par value, shares authorized, and and shares issued and outstanding as of December 31, 2022 and 2021, respectively||||||||
Redeemable non-controlling interest | ||||||||
Total temporary equity | ||||||||
Shareholders’ equity | ||||||||
Preferred stock, $ par value, shares authorized; Series B preferred stock, $ par value, shares authorized, shares issued and outstanding as of December 31, 2022 and 2021, respectively | ||||||||
Common stock, $ par value, shares authorized, and shares issued and outstanding as of December 31, 2022 and 2021, respectively | ||||||||
Additional paid-in capital | ||||||||
Accumulated deficit | ( | ) | ( | ) | ||||
Accumulated other comprehensive loss | ( | ) | ( | ) | ||||
Total shareholders’ equity | ||||||||
Total liabilities, temporary equity, and shareholders’ equity | $ | $ |
The accompanying notes are an integral part of these consolidated financial statements.
F-4 |
ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
For the Years Ended December 31, | ||||||||
2022 | 2021 | |||||||
Operating expenses | ||||||||
General and administrative | $ | $ | ||||||
Research and development | ||||||||
Impairment of intangible assets and goodwill | ||||||||
Depreciation and amortization | ||||||||
Total operating expenses | ||||||||
Loss from operations | ( | ) | ( | ) | ||||
Other income (expense) | ||||||||
Inducement expense | ( | ) | ||||||
Change in fair value of warrant liabilities | ||||||||
Change in fair value of investment option liability | ||||||||
Change in fair value of derivative liability | ( | ) | ||||||
Interest expense | ( | ) | ( | ) | ||||
Total other income | ||||||||
Net loss before income taxes | ( | ) | ( | ) | ||||
Income tax benefit | ||||||||
Net loss | ( | ) | ( | ) | ||||
Less preferred dividends attributable to non-controlling interest | ||||||||
Less deemed dividends attributable to accretion of embedded derivative at redemption value | ||||||||
Net loss attributable to shareholders | ( | ) | ( | ) | ||||
Other comprehensive loss | ||||||||
Foreign currency translation | ( | ) | ||||||
Comprehensive loss | $ | ( | ) | $ | ( | ) | ||
Net loss per share - basic and diluted | $ | ( | ) | $ | ( | ) | ||
Weighted average shares outstanding, basic and diluted |
The accompanying notes are an integral part of these consolidated financial statements.
F-5 |
ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CHANGES IN MEZZANINE EQUITY AND SHAREHOLDERS’ EQUITY
Series B Preferred Stock | Common Stock | Additional Paid-In | Accumulated | Accumulated Other Comprehensive | ||||||||||||||||||||||||||||
Shares | Amount | Shares | Amount | Capital | Deficit | Income (Loss) | Total | |||||||||||||||||||||||||
Balance at January 1, 2021 | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | ||||||||||||||||||||||
January 2021 registered direct offering, net of offering costs | — | |||||||||||||||||||||||||||||||
February 2021 registered direct offering, net of offering costs | — | |||||||||||||||||||||||||||||||
Consideration paid pursuant to amalgamation agreement | — | |||||||||||||||||||||||||||||||
Exercise of warrants | — | |||||||||||||||||||||||||||||||
Exercise of options | — | ( | ) | |||||||||||||||||||||||||||||
Induced conversion of stock options into restricted stock awards | — | |||||||||||||||||||||||||||||||
Stock-based compensation | — | — | ||||||||||||||||||||||||||||||
Common stock issued in lieu of cash for services | — | |||||||||||||||||||||||||||||||
Common stock issued pursuant to exercise of warrant put rights | — | ( | ) | |||||||||||||||||||||||||||||
Conversion of Series B preferred shares | ( | ) | ( | ) | ||||||||||||||||||||||||||||
Foreign exchange translation gain | — | — | ||||||||||||||||||||||||||||||
Net loss | — | — | ( | ) | ( | ) | ||||||||||||||||||||||||||
Balance at December 31, 2021 | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ |
The accompanying notes are an integral part of these consolidated financial statements.
F-6 |
ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CHANGES IN MEZZANINE EQUITY AND SHAREHOLDERS’ EQUITY
Series C Redeemable Preferred Stock | Redeemable Non-controlling Interest | Total Temporary | Common Stock | Additional Paid-In | Accumulated | Accumulated Other Comprehensive | Total Shareholders’ | |||||||||||||||||||||||||||||||||||||
Shares | Amount | Shares | Amount | Equity | Shares | Amount | Capital | Deficit | Loss | Equity | ||||||||||||||||||||||||||||||||||
Balance at January 1, 2022 | $ | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | ||||||||||||||||||||||||||||||||
February 2022 registered direct offering, net of offering costs | — | — | ||||||||||||||||||||||||||||||||||||||||||
Stock-based compensation | — | — | — | |||||||||||||||||||||||||||||||||||||||||
Conversion of RSUs into common shares | — | — | ( | ) | ||||||||||||||||||||||||||||||||||||||||
Redeemable non-controlling
interest, net of $ | — | — | ||||||||||||||||||||||||||||||||||||||||||
Issuance of redeemable Series C preferred stock | — | — | ( | ) | ( | ) | ||||||||||||||||||||||||||||||||||||||
Preferred dividends attributable to redeemable non-controlling interest | — | — | — | ( | ) | ( | ) | |||||||||||||||||||||||||||||||||||||
Accretion of embedded derivative to redemption value | — | — | — | ( | ) | ( | ) | |||||||||||||||||||||||||||||||||||||
Conversion of RSAs into common shares | — | — | ( | ) | ||||||||||||||||||||||||||||||||||||||||
July 2022 registered direct offering, PIPE offering, modification of warrants and exercise of pre-funded warrants, net of offering costs | — | — | ||||||||||||||||||||||||||||||||||||||||||
Issuance of rounded shares as a result of the reverse stock split | — | — | ( | ) | ||||||||||||||||||||||||||||||||||||||||
Redemption of Series C preferred stock | ( | ) | ( | ) | — | ( | ) | — | ||||||||||||||||||||||||||||||||||||
Foreign exchange translation loss | — | — | — | ( | ) | ( | ) | |||||||||||||||||||||||||||||||||||||
Net loss | — | — | — | ( | ) | ( | ) | |||||||||||||||||||||||||||||||||||||
Balance at December 31, 2022 | $ | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ |
The accompanying notes are an integral part of these consolidated financial statements.
F-7 |
ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
For the Years Ended December 31, | ||||||||
2022 | 2021 | |||||||
Cash Flows From Operating Activities: | ||||||||
Net loss | $ | ( | ) | $ | ( | ) | ||
Adjustments to reconcile net loss to cash used in operating activities | ||||||||
Change in fair value of warrant liability | ( | ) | ( | ) | ||||
Change in fair value of investment option liability | ( | ) | ||||||
Change in fair value of derivative liability | ||||||||
Stock-based compensation | ||||||||
Stock issued in lieu of cash for services | ||||||||
Impairment of intangible assets and goodwill | ||||||||
Non-cash income tax benefit | ( | ) | ( | ) | ||||
Inducement expense | ||||||||
Amortization of right-of-use asset | ||||||||
Amortization of intangible assets | ||||||||
Depreciation expense | ||||||||
Change in operating assets and liabilities: | ||||||||
Prepaid expenses and other current assets | ( | ) | ||||||
Accounts payable and accrued liabilities | ||||||||
Right-of-use operating lease liability | ( | ) | ( | ) | ||||
Net cash used in operating activities | ( | ) | ( | ) | ||||
Cash Flows From Investing Activities: | ||||||||
Purchases of property and equipment | ( | ) | ( | ) | ||||
Purchase of Diverse Bio license agreement | ( | ) | ||||||
Cash accretive acquisition of MagicMed | ||||||||
Net cash (used in) provided by investing activities | ( | ) | ||||||
Cash Flows From Financing Activities: | ||||||||
Proceeds from sale of common stock, warrants, and investment options, net of offering costs | ||||||||
Proceeds from the sale of redeemable non-controlling interest, net of offering costs (see Note 8) | ||||||||
Proceeds from warrant exercises, net of fees | ||||||||
Net cash provided by financing activities | ||||||||
Effect of foreign exchange rate on cash | ( | ) | ||||||
Net increase in cash | ||||||||
Cash at beginning of year | ||||||||
Cash at end of year | $ | $ | ||||||
Supplemental disclosure of cash and non-cash transactions: | ||||||||
Cash paid for interest | $ | $ | ||||||
Income taxes paid | $ | $ | ||||||
Investment options issued in conjunction with common stock issuance | $ | $ | ||||||
Modification of warrants as part of share capital raise | $ | $ | ||||||
Warrants issued in conjunction with common stock issuance | $ | $ | ||||||
Issuance of embedded derivative | $ | $ | ||||||
Preferred dividends attributable to redeemable non-controlling interest | $ | $ | ||||||
Accretion of embedded derivative to redemption value | $ | $ | ||||||
Issuance of Common Stock pursuant to MagicMed amalgamation | $ | $ | ||||||
Deferred tax liability incurred due to MagicMed amalgamation | $ | $ | ||||||
Conversion of preferred stock to common stock | $ | $ | ||||||
Fair value of warrants issued | $ | $ | ||||||
Right-of-use assets obtained in exchange for lease liabilities | $ | $ |
The accompanying notes are an integral part of these consolidated financial statements.
F-8 |
ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
NOTE 1. BUSINESS AND LIQUIDITY AND OTHER UNCERTAINTIES
Nature of Operations
Enveric Biosciences, Inc. (“Enveric Biosciences, Inc.” “Enveric” or the “Company”) is a pharmaceutical company developing innovative, evidence-based cannabinoid medicines. The head office of the Company is located in Naples, Florida. The Company has the following wholly owned subsidiaries: Jay Pharma Inc. (“Jay Pharma”), 1306432 B.C. Ltd. (“HoldCo”), MagicMed Industries, Inc. (“MagicMed”), and Enveric Canada. The Company has an Amalgamation Agreement (“Amalgamation Agreement”) and tender agreement (“Tender Agreement”) with Jay Pharma, which were entered into in prior years.
On May 24, 2021, the Company entered into an Amalgamation Agreement (the “Amalgamation Agreement”) with 1306432 B.C. Ltd., a corporation existing under the laws of the Province of British Columbia and a wholly-owned subsidiary of the Company (“HoldCo”), 1306436 B.C. Ltd., a corporation existing under the laws of the Province of British Columbia and a wholly-owned subsidiary of HoldCo (“Purchaser”), and MagicMed Industries Inc., a corporation existing under the laws of the Province of British Columbia (“MagicMed”), pursuant to which, among other things, the Company, indirectly through Purchaser, acquired all of the outstanding securities of MagicMed in exchange for securities of the Company by way of an amalgamation under the British Columbia Business Corporations Act, upon the terms and conditions set forth in the Amalgamation Agreement, such that, upon completion of the Amalgamation (as defined herein), the amalgamated corporation (“Amalco”) will be an indirect wholly-owned subsidiary of the Company. The Amalgamation was completed on September 16, 2021.
MagicMed Industries develops and commercializes psychedelic-derived pharmaceutical candidates. MagicMed’s psychedelic derivatives library, the Psybrary™, is an essential building block from which industry can develop new patented products. The initial focus of the Psybrary™ is on psilocybin and DMT derivatives, and it is then expected to be expanded to other psychedelics.
Akos Spin-Off
On May 11, 2022, the Company announced plans to transfer and spin-off its cannabinoid clinical development pipeline assets to Akos Biosciences, Inc. (formerly known as Acanna Therapeutics, Inc.), a majority owned subsidiary of the Company (hereafter referred to as “Akos”), which was incorporated on April 13, 2022, by way of dividend to Enveric shareholders (the “Spin-Off”). The Spin-Off will be subject to various conditions, including Akos meeting the qualifications for listing on the Nasdaq Stock Market, and if successful, would result in two standalone public companies. The new company as a result of the Spin-Off will be referred to as Akos. If the Spin-Off does not occur, the Company has guaranteed the redeemable non-controlling interest (“RNCI”).
On
May 5, 2022, the Company and Akos entered into a Securities Purchase Agreement (the “Akos Purchase Agreement”) with an
accredited investor (the “Akos Investor”), pursuant to which Akos agreed to sell to the Akos Investor up to an aggregate
of
Reverse Stock Split
On
July 14, 2022 the Company affected a
Going Concern, Liquidity and Other Uncertainties
The
Company has incurred a loss since inception resulting in an accumulated deficit of $
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ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
In
assessing the Company’s ability to continue as a going concern, the Company monitors and analyzes its cash and its ability to generate
sufficient cash flow in the future to support its operating and capital expenditure commitments. At December 31, 2022, the Company had
cash of $
As a result of these factors, management has concluded that there is substantial doubt about the Company’s ability to continue as a going concern for a period of one year after the date of the financial statements are issued. The Company’s consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Inflation Risks
The current inflationary trend existing in the North American economic environment is considered by the Company to be reasonably likely to have a material unfavorable impact on results of continuing operations. Higher rates of price inflation, as compared to recent prior levels of price inflation have caused a general increase the cost of labor and materials. In addition, there is an increased risk of the Company experiencing labor shortages as a result of a potential inability to attract and retain human resources due to increased labor costs resulting from the current inflationary environment.
Recent Developments
Nasdaq Notice
On February 18, 2022, the Company received a letter from the Listing Qualifications Department of the Nasdaq Stock Market indicating that, based upon the closing bid price of the Company’s common stock for the 30 consecutive business day period between January 5, 2022, through February 17, 2022, the Company did not meet the minimum bid price of $ per share required for continued listing on the Nasdaq Capital Market (“Nasdaq”) pursuant to Nasdaq Listing Rule 5550(a)(2). The letter also indicated that the Company will be provided with a compliance period of 180 calendar days, or until August 17, 2022 (the “Compliance Period”), in which to regain compliance pursuant to Nasdaq Listing Rule 5810(c)(3)(A).
On July 29, 2022, the Company received a letter from the Listing Qualifications Department of the Nasdaq Stock Market stating that for the last ten consecutive business days, from July 15 to July 28, 2022, the closing bid price of the Company’s common stock had been at $ per share or greater. Accordingly, the Company has regained compliance with Listing Rule 5550(a)(2).
NOTE 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis of Presentation and Principal of Consolidation
The accompanying consolidated financial statements have been prepared in accordance and in conformity with GAAP and the applicable rules and regulations of the Securities and Exchange Commission (the “SEC”) regarding consolidated financial information. All intercompany transactions have been eliminated in consolidation.
Reclassification
Certain reclassifications have been made to the prior period financial statements to conform to the current period financial statement presentation. These reclassifications had no effect on net earnings or cash flows as previously reported.
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ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Use of Estimates
The preparation of the consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amount of assets and liabilities at the date of the financial statements and expenses during the periods reported. By their nature, these estimates are subject to measurement uncertainty and the effects on the financial statements of changes in such estimates in future periods could be significant. Significant areas requiring management’s estimates and assumptions include determining the fair value of transactions involving common stock and the valuation of stock-based compensation, accruals associated with third party providers supporting research and development efforts, estimated fair values of long lives assets used to record impairment charges related to intangible assets, acquired in-process research and development (“IPR&D”), and goodwill, and allocation of purchase price in business acquisitions. Actual results could differ from those estimates.
Foreign Currency Translation
From inception through December 31, 2022, the reporting currency of the Company was the United States dollar while the functional currency of certain of the Company’s subsidiaries was the Canadian dollar. For the reporting periods ended December 31, 2022 and December 31, 2021, the Company engaged in a number of transactions denominated in Canadian dollars. As a result, the Company is subject to exposure from changes in the exchange rates of the Canadian dollar and the U.S. dollar.
The Company translates the assets and liabilities of its Canadian subsidiaries into the U.S. dollar at the exchange rate in effect on the balance sheet date. Revenues and expenses are translated at the average exchange rate in effect during each monthly period. Unrealized translation gains and losses are recorded as foreign currency translation gain (loss), which is included in the consolidated statements of shareholders’ equity as a component of accumulated other comprehensive income (loss).
The Company has not entered into any financial derivative instruments that expose it to material market risk, including any instruments designed to hedge the impact of foreign currency exposures. The Company may, however, hedge such exposure to foreign currency exchange fluctuations in the future.
Adjustments that arise from exchange rate changes on transactions denominated in a currency other than the local currency are included in other comprehensive income (loss) in the consolidated statements of operations and comprehensive income (loss) as incurred.
Cash and Cash Equivalents
The Company considers all highly liquid investments purchased with an original maturity of three months or less to be cash equivalents. The Company did not have any cash equivalents as of December 31, 2022 and 2021.
Concentration of Credit Risk
Financial
instruments that potentially subject the Company to concentrations of credit risk consist of cash accounts in a financial institution,
which at times, may exceed the federal depository insurance coverage of $
Comprehensive Loss
Comprehensive loss consists of two components, net loss and other comprehensive income (loss). Other comprehensive loss refers to revenue, expenses, gains, and losses that under GAAP are recorded as an element of shareholders’ equity but are excluded from net loss. Other comprehensive loss consists of foreign currency translation adjustments from those subsidiaries not using the U.S. dollar as their functional currency.
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ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Business Combinations
The Company accounts for business combinations under Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 805, “Business Combinations” (“ASC 805”) using the acquisition method of accounting, and accordingly, the assets and liabilities of the acquired business are recorded at their fair values at the date of acquisition. For transactions that are business combinations, the Company evaluates the existence of goodwill. Goodwill represents the excess purchase price over the fair value of the tangible net assets and intangible assets acquired in a business combination. ASC 805-10 also specifies criteria that intangible assets acquired in a business combination must meet to be recognized and reported apart from goodwill. All acquisition costs are expensed as incurred. Upon acquisition, the accounts and results of operations are consolidated as of and subsequent to the acquisition date.
The estimated fair value of net assets acquired, including the allocation of the fair value to identifiable assets and liabilities, was determined using established valuation techniques. A fair value measurement is determined as the price the Company would receive to sell an asset or pay to transfer a liability in an orderly transaction between market participants at the measurement date. In the context of purchase accounting, the determination of fair value often involves significant judgments and estimates by management, including the selection of valuation methodologies, estimates of future revenues, costs and cash flows, discount rates, and selection of comparable companies. The estimated fair values reflected in the purchase accounting are subject to management’s judgment.
Intangible Assets
Intangible assets consist of the Psybrary™ and Patent Applications, In Process Research and Development (“IPR&D”) and license agreements. Psybrary™ and Patent Applications intangible assets are valued using the relief from royalty method. The cost of license agreements is amortized over the economic life of the license. The Company assesses the carrying value of its intangible assets for impairment each year.
IPR&D intangible assets are acquired in conjunction with the acquisition of a business and are assigned a fair value, using the multi-period excess earnings method, related to incomplete research projects which, at the time of acquisition, have not reached technological feasibility. The amounts are capitalized and are accounted for as indefinite-lived intangible assets, subject to impairment testing until completion or abandonment of the projects. Upon successful completion of each project, the Company will make a determination as to the then-useful life of the intangible asset, generally determined by the period in which the substantial majority of the cash flows are expected to be generated, and begin amortization. The Company tests its intangible assets for impairment at least annually and whenever events or circumstances change that indicate impairment may have occurred. A significant amount of judgment is involved in determining if an indicator of impairment has occurred. Such indicators may include, among others and without limitation: a significant decline in the Company’s expected future cash flows; a sustained, significant decline in the Company’s stock price and market capitalization; a significant adverse change in legal factors or in the business climate of the Company’s segments; unanticipated competition; and slower growth rates. If the fair value determined is less than the carrying amount, an impairment loss is recognized in operating results.
Goodwill
The Company tests goodwill for potential impairment at least annually, or more frequently if an event or other circumstance indicates that the Company may not be able to recover the carrying amount of the net assets of the reporting unit. The Company has determined that the reporting unit is the entire company, due to the integration of all of the Company’s activities. In evaluating goodwill for impairment, the Company may assess qualitative factors to determine whether it is more likely than not (that is, a likelihood of more than 50%) that the fair value of a reporting unit is less than its carrying amount. If the Company bypasses the qualitative assessment, or if the Company concludes that it is more likely than not that the fair value of a reporting unit is less than its carrying value, then the Company performs a quantitative impairment test by comparing the fair value of a reporting unit with its carrying amount.
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ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Property & Equipment
Property
and equipment are recorded at cost. Major property additions, replacements, and betterments are capitalized, while maintenance and repairs
that do not extend the useful lives of an asset or add new functionality are expensed as incurred. Depreciation and amortization are
recorded using the straight-line method over the respective estimated useful lives of the Company’s long-lived assets. The estimated
useful lives are typically
Warrant Liability and Investment Options
The Company evaluates all of its financial instruments, including issued stock purchase warrants and investment options, to determine if such instruments are derivatives or contain features that qualify as embedded derivatives, pursuant to ASC 480 and FASB ASC 815. The Company accounts for warrants and investment options for shares of the Company’s common stock that are not indexed to its own stock as derivative liabilities at fair value on the consolidated balance sheets. The Company accounts for common stock warrants and investment options with put options as liabilities under ASC 480. Such warrants and investment options are subject to remeasurement at each consolidated balance sheet date and any change in fair value is recognized as a component of other expense on the consolidated statements of operations. The Company will continue to adjust the liability for changes in fair value until the earlier of the exercise or expiration of such common stock warrants and investment options. At that time, the portion of the warrant liability and investment options related to such common stock warrants will be reclassified to additional paid-in capital.
Modification of Warrants
A change in any of the terms or conditions of warrants is accounted for as a modification. For a warrant modification accounted for under ASC 815, the effect of a modification shall be measured as the difference between the fair value of the modified warrant over the fair value of the original warrant immediately before its terms are modified, measured based on the fair value of the shares and other pertinent factors at the modification date. The accounting for incremental fair value of warrants is based on the specific facts and circumstances related to the modification. When a modification is directly attributable to equity offerings, the incremental change in fair value of the warrants are accounted for as equity issuance costs.
Derivative Liability
The Company evaluates its financial instruments to determine if such instruments are derivatives or contain features that qualify as embedded derivatives in accordance with ASC 815. For derivative financial instruments that are accounted for as assets or liabilities, the derivative instrument is initially recorded at its fair value on the grant date and is then re-valued at each reporting date, with changes in the fair value reported in the consolidated statements of operations and comprehensive loss. The classification of derivative instruments, including whether such instruments should be recorded as assets or liabilities or as equity, is evaluated at the end of each reporting period. Derivative liabilities are classified in the consolidated balance sheets as current or non-current based on whether or not net-cash settlement or conversion of the instrument could be required within 12 months of the balance sheet date.
Offering Costs
The Company allocates offering costs to the different components of the capital raise on a pro rata basis. Any offering costs allocated to common stock are charged directly to additional paid-in capital. Any offering costs allocated to warrant liabilities are charged to general and administrative expenses on the Company’s consolidated statement of operations and comprehensive loss.
Income Taxes
The Company utilizes an asset and liability approach for financial accounting and reporting for income taxes. The provision for income taxes is based upon income or loss after adjustment for those permanent items that are not considered in the determination of taxable income. Deferred income taxes represent the tax effects of differences between the financial reporting and tax basis of the Company’s assets and liabilities at the enacted tax rates in effect for the years in which the differences are expected to reverse.
F-13 |
ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
The Company evaluates the recoverability of deferred tax assets and establishes a valuation allowance when it is more likely than not that some portion or all the deferred tax assets will not be realized. Management makes judgments as to the interpretation of the tax laws that might be challenged upon an audit and cause changes to previous estimates of tax liabilities. In management’s opinion, adequate provisions for income taxes have been made. If actual taxable income by tax jurisdiction varies from estimates, additional allowances or reversals of reserves may be necessary.
Tax benefits are recognized only for tax positions that are more likely than not to be sustained upon examination by tax authorities. The amount recognized is measured as the largest amount of benefit that is greater than 50 percent likely to be realized upon settlement. A liability for “unrecognized tax benefits” is recorded for any tax benefits claimed in the Company’s tax returns that do not meet these recognition and measurement standards. As of December 31, 2022 and 2021, no liability for unrecognized tax benefits was required to be recorded.
The Company’s policy for recording interest and penalties associated with tax audits is to record such items as a component of operating expenses. There were no amounts accrued for penalties and interest for the years ended December 31, 2022 and 2021. The Company does not expect its uncertain tax positions to change during the next twelve months. Management is currently unaware of any issues under review that could result in significant payments, accruals or material deviations from its position.
The Company has identified its United States and Canadian federal tax return, its state and provincial tax returns in Florida and Ontario, CA as its “major” tax jurisdictions. The Company is in the process of filing its corporate tax returns for the years ended December 31, 2022 and 2021. Net operating losses for these periods will not be available to reduce future taxable income until the returns are filed.
The Company follows ASC 718, Compensation - Stock Compensation, which addresses the accounting for stock-based payment transactions, requiring such transactions to be accounted for using the fair value method. Awards of shares for property or services are recorded at the more readily measurable of the estimated fair value of the stock award and the estimated fair value of the service. The Company uses the Black-Scholes option-pricing model to determine the grant date fair value of certain stock-based awards under ASC 718. The assumptions used in calculating the fair value of stock-based awards represent management’s reasonable estimates and involve inherent uncertainties and the application of management’s judgment. Fair value of restricted stock units or restricted stock awards is determined by the closing price per share of the Company’s common stock on the date of award grant.
The estimated fair value is amortized as a charge to earnings on a straight-line basis, for awards or portions of awards that do not require specified milestones or performance criteria as a vesting condition and also depending on the terms and conditions of the award, and the nature of the relationship of the recipient of the award to the Company. The Company records the grant date fair value in line with the period over which it was earned. For employees and consultants, this is typically considered to be the vesting period of the award. The Company accounts for forfeitures as they occur.
The estimated fair value of awards that require specified milestones or recipient performance are charged to expense when such milestones or performance criteria are probable to be met.
Restricted stock units, restricted stock awards, and stock options are granted at the discretion of the Compensation Committee of the Company’s board of directors (the “Board of Directors”). These awards are restricted as to the transfer of ownership and generally vest over the requisite service periods, typically over a 12 to 48-month period. A significant portion of these awards may include vesting terms that include, without limitation, defined volume weighted average price levels being achieved by the Company’s Common Stock, specific performance milestones, employment, or engagement by the Company, with no assurances of achievement of any such vesting conditions, if applicable.
The value of RSU’s is equal to the product of the number of units awarded, multiplied by the closing price per share of the Company’s Common Stock on the date of the award. The terms and conditions of each RSU is defined in the RSU agreement and includes vesting terms that consist of any or all of the following: immediate vesting, vesting over a defined period of time, vesting based on achievement of a defined volume weighted average price levels at specified times, vesting based on achievement of specific performance milestones within a specific time frame, change of control, termination of the employee without cause by the Company, resignation of the employee with good cause. The value assigned to each RSU is charged to expense based on the vesting terms, as follows: value of RSU’s that vest immediately are charged to expense on the date awarded, value of RSU’s that vest based upon time, or achievement of stock price levels over a period of time are charged to expense on a straight line basis over the time frame specified in the RSU and the value of RSU’s that vest based upon achievement of specific performance milestones are charged to expense during the period that such milestone is achieved. Vested RSU’s may be converted to shares of Common Stock of an equivalent number upon either the termination of the recipient’s employment with the Company, or in the event of a change in control. If the recipient is not an employee, such person’s engagement with the Company must either be terminated prior to such conversion of RSU’s to shares of Common Stock, or in the event of a change in control. Furthermore, as required by Section 409A of the Internal Revenue Code, if the recipient is a “specified employee” (generally, certain officers and highly compensated employees of publicly traded companies), such recipient may only convert vested RSU’s into shares of Common Stock no earlier than the first day of the seventh month following such recipients termination of employment with the Company, or the event of change in control.
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ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
The value of RSA’s is equal to the product of the number of restricted shares awarded, multiplied by the closing price per share of the Company’s Common Stock on the date of the award. The terms and conditions of each RSA is defined in the RSA agreement and includes vesting terms that consist of any or all of the following: immediate vesting, vesting over a defined period of time, or vesting based on achievement of a defined volume weighted average price levels at specified times. Upon vesting, the recipient may receive restricted stock which includes a legend prohibiting sale of the shares during a restriction period that is defined in the RSA agreement. Termination of employment by or engagement with the Company is not required for the recipient to receive restricted shares of Common Stock. The value assigned to each RSA is charged to expense based on the vesting terms, as follows: value of RSA’s that vest immediately are charged to expense on the date awarded, value of RSA’s that vest based upon time, or achievement of stock price levels over a period of time are charged to expense on a straight-line basis over the time frame specified in the RSU.
Basic net loss per share is computed by dividing net loss by the weighted average number of shares of common stock outstanding during the period. Diluted earnings per share is computed using the weighted average number of common shares and, if dilutive, potential common shares outstanding during the period. Potential common shares consist of the incremental common shares issuable upon the exercise of stock options and warrants (using the treasury stock method). The computation of basic net loss per share for the years ended December 31, 2022 and 2021 excludes potentially dilutive securities. The computations of net loss per share for each period presented is the same for both basic and fully diluted. In accordance with ASC 260-10-45-13, penny warrants were included in the calculation of weighted average shares outstanding for purposes of calculating basic and diluted earnings per share.
During
the year ended December 31, 2022 the Company issued
For the years ended December 31, | ||||||||
2022 | 2021 | |||||||
Warrants to purchase shares of common stock | ||||||||
Restricted stock units - vested and unissued | ||||||||
Restricted stock units - unvested | ||||||||
Restricted stock awards - vested and unissued | ||||||||
Restricted stock awards - unvested | ||||||||
Investment options to purchase shares of common stock | ||||||||
Options to purchase shares of common stock | ||||||||
Total potentially dilutive securities |
Fair Value Measurements
Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. To increase the comparability of fair value measures, the following hierarchy prioritizes the inputs to valuation methodologies used to measure fair value:
Level 1 - Valuations based on quoted prices for identical assets and liabilities in active markets.
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ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Level 2 - Valuations based on observable inputs other than quoted prices included in Level 1, such as quoted prices for similar assets and liabilities in active markets, quoted prices for identical or similar assets and liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable market data.
Level 3 - Valuations based on unobservable inputs reflecting our own assumptions, consistent with reasonably available assumptions made by other market participants. These valuations require significant judgment.
For certain financial instruments, including cash and accounts payable, the carrying amounts approximate their fair values as of December 31, 2022 and 2021 because of their short-term nature.
The following table provides the financial liabilities measured on a recurring basis and reported at fair value on the balance sheets as of December 31, 2022 and 2021 and indicates the fair value of the valuation inputs the Company utilized to determine such fair value of warrant liabilities, derivative liability, and investment options:
Level | December 31, 2022 | December 31, 2021 | ||||||||||
Warrant liabilities - January 2021 Warrants | 3 | $ | $ | |||||||||
Warrant liabilities - February 2021 Warrants | 3 | |||||||||||
Warrant liabilities - February 2022 Warrants | 3 | |||||||||||
Fair value of warrant liability as of December 31, 2022 | $ | $ |
Level | December 31, 2022 | December 31, 2021 | ||||||||||
Derivative liability - May 2022 | 3 | $ | $ | |||||||||
Fair value of derivative liability as of December 31, 2022 | $ | $ |
Level | December 31, 2022 | December 31, 2021 | ||||||||||
Wainwright investment options | 3 | $ | $ | |||||||||
RD investment options | 3 | |||||||||||
PIPE investment options | 3 | |||||||||||
Fair value of investment option liability as of December 31, 2022 | $ | $ |
The warrant liabilities, derivative liability, and investment options are all classified as Level 3, for which there is no current market for these securities such as the determination of fair value requires significant judgment or estimation. Changes in fair value measurement categorized within Level 3 of the fair value hierarchy are analyzed each period based on changes in estimates or assumptions and recorded as appropriate.
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ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Initial measurement
The Company established the initial fair value of its warrant liabilities at the respective dates of issuance. The Company used a Black Scholes valuation model in order to determine their value. The key inputs into the Black Scholes valuation model for the initial valuations of the warrant liabilities are below:
February 2022 Warrants | February 2022 Post-Modification Warrants (See Note 7) | |||||||
February 15, 2022 | July 26, 2022 | |||||||
Term (years) | ||||||||
Stock price | $ | $ | ||||||
Exercise price | $ | $ | ||||||
Dividend yield | % | % | ||||||
Expected volatility | % | % | ||||||
Risk free interest rate | % | % | ||||||
Number of warrants | ||||||||
Value (per share) | $ | $ |
The Company established the initial fair value of its derivative liability at the respective date of issuance. The Company used a Weighted Expected Return valuation model in order to determine their value. The key inputs into the Weighted Expected Return valuation model for the initial valuations of the warrant liabilities are below:
May 2022 Derivative Liability | ||||
May 5, 2022 | ||||
Principal | $ | |||
Dividend rate | % | |||
Market rate | % |
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ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
The Company established the initial fair value of its investment options at the respective dates of issuance. The Company used a Black Scholes valuation model in order to determine their value. The key inputs into the Black Scholes valuation model for the initial valuations of the investment options are below:
Wainwright Options | RD Options | PIPE Options | ||||||||||
July 26, 2022 | July 26, 2022 | July 26, 2022 | ||||||||||
Term (years) | ||||||||||||
Stock price | $ | $ | $ | |||||||||
Exercise price | $ | $ | $ | |||||||||
Dividend yield | % | % | % | |||||||||
Expected volatility | % | % | % | |||||||||
Risk free interest rate | % | % | % | |||||||||
Number of investment options | ||||||||||||
Value (per share) | $ | $ | $ |
Subsequent measurement
The following table presents the changes in fair value of the warrant liabilities, derivative liability, and investment options that are classified as Level 3:
Total Warrant Liabilities | ||||
Fair value as of December 31, 2020 | $ | |||
Initial value of warrant liability | ||||
Change in fair value | ( | ) | ||
Fair value as of December 31, 2021 | $ | |||
Issuance of February 2022 warrants | ||||
Change in fair value due to modification of February 2022 warrants as part of July 2022 raise | ||||
Change in fair value | ( | ) | ||
Fair value of warrant liability as of December 31, 2022 | $ |
Total Derivative Liability | ||||
Fair value as of December 31, 2021 | $ | |||
Issuance of May 2022 convertible preferred stock | ||||
Change in fair value | ||||
Fair value of derivative liability as of December 31, 2022 | $ |
Total Investment Options | ||||
Fair value as of December 31, 2021 | $ | |||
Issuance of July 2022 investment options | ||||
Change in fair value | ( | ) | ||
Fair value of investment option liability as of December 31, 2022 | $ |
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ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
The key inputs into the Black Scholes valuation model for the Level 3 valuations of the warrant liabilities as of December 31, 2022 are below:
January 2021 Warrants | February 2021 Warrants | February 2022 Warrants | February
2022 Post-Modification Warrants | |||||||||||||
Term (years) | ||||||||||||||||
Stock price | $ | $ | $ | $ | ||||||||||||
Exercise price | $ | $ | $ | $ | ||||||||||||
Dividend yield | % | % | % | % | ||||||||||||
Expected volatility | % | % | % | % | ||||||||||||
Risk free interest rate | % | % | % | % | ||||||||||||
Number of warrants | ||||||||||||||||
Value (per share) | $ | $ | $ | $ |
The key inputs into the Weighted Expected Return valuation model for the Level 3 valuations of the derivative liability as of December 31, 2022 are below:
May 2022 Derivative Liability | ||||
Principal | $ | |||
Dividend rate | % | |||
Market rate | % |
The key inputs into the Black Scholes valuation model for the Level 3 valuations of the investment options as of December 31, 2022 are below:
Wainwright Options | RD Options | PIPE Options | ||||||||||
Term (years) | ||||||||||||
Stock price | $ | $ | $ | |||||||||
Exercise price | $ | $ | $ | |||||||||
Dividend yield | % | % | % | |||||||||
Expected volatility | % | % | % | |||||||||
Risk free interest rate | % | % | % | |||||||||
Number of investment options | ||||||||||||
Value (per share) | $ | $ | $ |
Research and Development
Research and development expenses are charged to operations as incurred. Research and development expenses include, among other things, internal and external costs associated with preclinical development, pre-commercialization manufacturing expenses, and clinical trials. The Company accrues for costs incurred as the services are being provided by monitoring the status of the trial or services provided and the invoices received from its external service providers. In the case of clinical trials, a portion of the estimated cost normally relates to the projected cost to treat a patient in the trials, and this cost is recognized based on the number of patients enrolled in the trial. As actual costs become known, the Company adjusts its accruals accordingly.
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ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Leases
Operating lease assets are included within right-of-use operating lease asset and operating lease liabilities are included in current portion of right-of-use operating lease obligation and non-current portion of right-of-use operating lease obligation on the consolidated balance sheets as of December 31, 2022 and 2021. The Company has elected not to present short-term leases as these leases have a lease term of 12 months or less at lease inception and do not contain purchase options or renewal terms that the Company is reasonably certain to exercise. All other lease assets and lease liabilities are recognized based on the present value of lease payments over the lease term at commencement date. Because most of the Company’s leases do not provide an implicit rate of return, the Company used an incremental borrowing rate based on the information available at adoption date in determining the present value of lease payments.
A lease qualifies as a finance lease if any of the following criteria are met at the inception of the lease: (i) there is a transfer of ownership of the leased asset to the Company by the end of the lease term, (ii) the Company holds an option to purchase the leased asset that it is reasonably certain to exercise, (iii) the lease term is for a major part of the remaining economic life of the leased asset, (iv) the present value of the sum of lease payments equals or exceeds substantially all of the fair value of the leased asset, or (v) the nature of the leased asset is specialized to the point that it is expected to provide the lessor no alternative use at the end of the lease term. All other leases are recorded as operating leases. Finance lease payments are bifurcated into (i) a portion that is recorded as interest expense and (ii) a portion that reduces the finance liability associated with the lease. The Company did not have any finance leases as of December 31, 2022 and 2021.
Redeemable Non-controlling Interest
In connection with the issuance of Akos Series A Preferred Stock, the Akos Purchase Agreement and certificate of designation contain a put right guaranteed by the Company as defined in Note 8. Applicable accounting guidance requires an equity instrument that is redeemable for cash or other assets to be classified outside of permanent equity if it is redeemable (a) at a fixed or determinable price on a fixed or determinable date, (b) at the option of the holder, or (c) upon the occurrence of an event that is not solely within the control of the issuer. As a result of this feature, the Company recorded the non-controlling interests as redeemable non-controlling interests and classified them in temporary equity within its consolidated balance sheet initially at its acquisition-date estimated redemption value or fair value. In addition, the Company has elected to recognize changes in the redemption value immediately as they occur and adjust the carrying amount of the instrument by accreting the embedded derivative at each reporting period over 12 months.
The Akos Series A Preferred Certificate of Designations provides that upon the earlier of (i) the one-year anniversary of May 5, 2022, and only in the event that the Spin-Off has not occurred; or (ii) such time that Akos and the Company have abandoned the Spin-Off or the Company is no longer pursuing the Spin-Off in good faith, the holders of the Akos Series A Preferred Stock shall have the right (the “Put Right”), but not the obligation, to cause Akos to purchase all or a portion of the Akos Series A Preferred Stock for a purchase price equal to $ per share, subject to certain adjustments as set forth in the Akos Series A Preferred Certificate of Designations, plus all the accrued but unpaid dividends per share. Pursuant to the Akos Purchase Agreement, the Company has guaranteed the payment of the purchase price for the shares purchased under the Put Right.
Segment Reporting
The Company determines its reporting units in accordance with FASB ASC 280, “Segment Reporting” (“ASC 280”). The Company evaluates a reporting unit by first identifying its operating segments under ASC 280. The Company then evaluates each operating segment to determine if it includes one or more components that constitute a business. If there are components within an operating segment that meet the definition of a business, the Company evaluates those components to determine if they must be aggregated into one or more reporting units. If applicable, when determining if it is appropriate to aggregate different operating segments, the Company determines if the segments are economically similar and, if so, the operating segments are aggregated. The Company has multiple operations related to psychedelics and cannabinoids. Both of these operations exist under one reporting unit: Enveric. The Company has one operating segment and reporting unit. The Company is organized and operated as one business. Management reviews its business as a single operating segment, using financial and other information rendered meaningful only by the fact that such information is presented and reviewed in the aggregate.
Recent Accounting Pronouncements
In August 2020, the FASB issued ASU 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40) (“ASU 2020-06”) to simplify certain financial instruments. ASU 2020-06 eliminates the current models that require separation of beneficial conversion and cash conversion features from convertible instruments and simplifies the derivative scope exception guidance pertaining to equity classification of contracts in an entity’s own equity. The new standard also introduces additional disclosures for convertible debt and freestanding instruments that are indexed to and settled in an entity’s own equity. ASU 2020-06 amends the diluted earnings per share guidance, including the requirement to use the if-converted method for all convertible instruments. ASU 2020-06 is effective for fiscal years beginning after December 15, 2021 and should be applied on a full or modified retrospective basis. Early adoption is permitted, but no earlier than fiscal years beginning after December 15, 2020, including interim periods within those fiscal years. The Company will adopt ASU 2020-06 effective January 1, 2024.
F-20 |
ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
NOTE 3. AMALGAMATION WITH MAGICMED INDUSTRIES INC.
On May 24, 2021, the Company entered into an Amalgamation Agreement (the “Amalgamation Agreement”) with 1306432 B.C. Ltd., a corporation existing under the laws of the Province of British Columbia and a wholly-owned subsidiary of the Company (“HoldCo”), 1306436 B.C. Ltd., a corporation existing under the laws of the Province of British Columbia and a wholly-owned subsidiary of HoldCo (“Purchaser”), and MagicMed Industries Inc., a corporation existing under the laws of the Province of British Columbia (“MagicMed”), pursuant to which, among other things, the Company, indirectly through Purchaser, acquired all of the outstanding securities of MagicMed in exchange for securities of the Company by way of an amalgamation under the British Columbia Business Corporations Act, upon the terms and conditions set forth in the Amalgamation Agreement, such that, upon completion of the Amalgamation (as defined herein), the amalgamated corporation (“Amalco”) will be an indirect wholly-owned subsidiary of the Company. The Amalgamation was completed on September 16, 2021.
At
the effective time of the Amalgamation (the “Effective Time”), holders of outstanding common shares of MagicMed (the “MagicMed
Shares”) received such number of shares of common stock of the Company (“Company Shares”) representing, together with
the Company Shares issuable upon exercise of the Warrants and the Converted Options (each as defined herein), approximately
The aggregate number of Company Shares that the Company issued in connection with the Amalgamation (collectively, the “Share Consideration”) was in excess of % of the Company’s pre-transaction outstanding Company Shares. Accordingly, the Company sought and received stockholder approval of the issuance of the Share Consideration in the Amalgamation in accordance with the Nasdaq Listing Rules.
Pursuant to the terms of the Amalgamation Agreement, the Company appointed, effective as of the Effective Time two individuals selected by MagicMed to the Company Board of Directors, Dr. Joseph Tucker and Dr. Brad Thompson.
The Amalgamation Agreement contained representations and warranties, closing deliveries and indemnification provisions customary for a transaction of this nature. The closing of the Amalgamation was conditioned upon, among other things, (i) the Share Consideration being approved for listing on Nasdaq, (ii) the effectiveness of a Registration Statement on Form S-4 registering the Share Consideration (the “S-4 Registration Statement”) and (iii) the approval (a) of the MagicMed stockholders of the Amalgamation and (b) of the Company’s stockholders of each of the Amalgamation and the issuance of the Share Consideration in the Amalgamation. The closing of the Amalgamation occurred on September 16, 2021.
MagicMed Industries develops and commercializes psychedelic-derived pharmaceutical candidates. MagicMed’s psychedelic derivatives library, the Psybrary™, is an essential building block from which industry can develop new patented products. The initial focus of the Psybrary™ is on psilocybin and DMT derivatives, and it is then expected to be expanded to other psychedelics.
On
September 16, 2021, the Company completed the Acquisition. In exchange for a total purchase price valued at $
F-21 |
ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Aggregate
goodwill of $
The following table represents the purchase price:
Stock ( common shares issued) | $ | |||
Fair value of warrants | ||||
Fair value of options | ||||
Total Purchase Price | $ |
The Acquisition is being accounted for as a business combination in accordance with ASC 805.
The following table summarizes the purchase price allocations relating to the Acquisition:
Description | Fair Value | |||
Assets acquired: | ||||
Cash | $ | |||
Prepaid expenses and other current assets | ||||
Government remittances recoverable | ||||
Property and equipment | ||||
Right-of-use lease assets | ||||
Other assets | ||||
In process research and development | ||||
Psybrary and patent applications | ||||
Goodwill | ||||
Total assets acquired | $ | |||
Liabilities assumed: | ||||
Accounts payable | $ | |||
Accrued expenses and other liabilities | ||||
Right-of-use lease liabilities | ||||
Deferred tax liabilities | ||||
Total liabilities assumed | ||||
Estimated fair value of net assets acquired attributable to the Company | $ |
The
goodwill represents the excess fair value after the allocation to the identifiable net assets, with $
F-22 |
ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Certain adjustments to the assessed fair values of the assets and liabilities made subsequent to the acquisition date, but within the measurement period, which is up to one year, are recorded as adjustments to goodwill. Any adjustments subsequent to the measurement period are recorded in income.
During the fourth quarter of 2021, the Company finalized the opening balance sheet and valuations for the assets acquired and liabilities assumed related to the acquisition of MagicMed and adjusted provisional amounts as follows:
● | The
Company recorded a $ | |
● | The
Company further decreased the IPR&D asset by $ | |
● | The
Company recorded a $ |
Total
acquisition-related costs for the Acquisition incurred by the Company during the year ended December 31, 2021 was approximately $
Historical and Proforma Financial Information
The
amounts of MagicMed’s revenues and net loss included in the Company’s consolidated statements of operations and comprehensive
loss for the period from the acquisition date to December 31, 2021 were $
For the year ended December 31, | ||||
2021 | ||||
Revenues | $ | |||
Net loss | $ | ( | ) |
NOTE 4. INTANGIBLE ASSETS AND GOODWILL
The Company performs an annual impairment test at the reporting unit level as of December 31 of each fiscal year. As of December 31, 2022, the Company qualitatively assessed whether it is more likely than not that the respective fair value of the Company’s reporting unit is less than its carrying amount, including goodwill. Beginning with the fourth quarter of 2021 and throughout 2022, the Company experienced a sustained decline in the quoted market price of the Company’s common stock and as a result the Company determined that as of December 31, 2022 it was more likely than not that the carrying value of these acquired intangibles exceeded their estimated fair value. Accordingly, the Company performed an impairment analysis as of December 31, 2022 using the income approach. This analysis required significant judgments, including primarily the estimation of future development costs, the probability of success in various phases of its development programs, potential post launch cash flows and a risk-adjusted weighted average cost of capital. Pursuant to ASU 2017-04, the Company recorded a goodwill and intangible asset impairment charge as of December 31, 2022 and a goodwill and intangible asset impairment charge as of December 31, 2021 for the excess of the reporting unit’s carrying value over its fair value. The following table provides the Company’s goodwill, indefinite and definite lives intangible assets as of December 31, 2022 and 2021.
F-23 |
ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
As of December 31, 2022 and 2021, the Company’s intangible assets consisted of:
Goodwill | ||||
Balance at December 31, 2020 | $ | |||
Acquired during the year | ||||
Impairment losses | ( | ) | ||
Loss on currency translation | ( | ) | ||
Balance at December 31, 2021 | $ | |||
Impairment losses | ( | ) | ||
Loss on currency translation | ( | ) | ||
Balance at December 31, 2022 | $ | |||
Indefinite lived intangible assets | ||||
Balance at December 31, 2020 | $ | |||
Acquired during the year | ||||
Impairment losses | ( | ) | ||
Loss on currency translation | ( | ) | ||
Balance at December 31, 2021 | $ | |||
Impairment losses | ( | ) | ||
Loss on currency translation | ( | ) | ||
Balance at December 31, 2022 | $ | |||
Definite lived intangible assets | ||||
Balance at December 31, 2020 | $ | |||
Acquired during the year | ||||
Amortization | ( | ) | ||
Impairment loss | ( | ) | ||
Gain on currency translation | ||||
Balance at December 31, 2021 | $ | |||
Amortization | ( | ) | ||
Balance at December 31, 2022 | $ |
For
goodwill, impairment losses amounted to $
For
goodwill, aggregate impairment amounted to $
F-24 |
ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
The Company amortizes definite lived intangible assets on a straight-line basis over their estimated useful lives. Amortization expense of identified intangible assets based on the carrying amount as of December 31, 2022 is as follows:
Year ending December 31, | ||||
2023 | $ | |||
2024 | ||||
2025 | ||||
$ |
Acquisition of Diverse Bio License Agreement
On March 5, 2021, the Company entered into an Exclusive License Agreement (the “DB Agreement”) with Diverse Biotech, Inc. (“Diverse”), pursuant to which the Company acquired an exclusive, perpetual license to develop five therapeutic candidates (collectively, the “Agents”) with the goal of alleviating the side effects that cancer patients experience. Under the terms of the DB Agreement, Diverse has granted the Company an exclusive license to its intellectual property rights covering the Agents and its products. In exchange, the Company has granted Diverse the right to information relating to the Agents developed for the express purpose of using such information to obtain patent rights, which right terminates upon the issuance or denial of the patent rights.
Under
the DB Agreement, the Company will maintain sole responsibility and ownership of the development and commercialization of the Agents
and its products. Diverse has agreed not to develop or commercialize any agent or product that would compete with the Agents, or its
products containing the Agents, at any time during or after the term of the DB Agreement. If Diverse intends to license, sell, or transfer
any other molecules linked with cannabinoids not granted to the Company under the terms of the DB Agreement, the Company will have the
first right, but not the obligation, to negotiate an agreement with Diverse for such cannabinoids. The Company agreed to pay Diverse
an up-front investment payment in the amount of $
The term of the DB Agreement shall continue for as long as the Company intends to develop or commercialize the new drugs, unless earlier terminated by either Party. The Agreement may be terminated by either party upon ninety (90) days written notice of an uncured material breach or in the event of bankruptcy or insolvency. In addition, the Company has the right to terminate the DB Agreement at any time upon sixty (60) days’ prior written notice to Diverse.
NOTE 5. PROPERTY AND EQUIPMENT
Property and equipment consists of the following assets which are located in Calgary, Canada and placed in service by Enveric Biosciences Canada, Inc (“EBCI”), with all amounts translated into U.S. dollars:
December 31, 2022 | December 31, 2021 | |||||||
Lab equipment | $ | $ | ||||||
Computer equipment and leasehold improvements | ||||||||
Less: Accumulated depreciation | ( | ) | ( | ) | ||||
Property and equipment, net of accumulated depreciation | $ | $ |
Depreciation
expense was $
F-25 |
ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
NOTE 6. ACCRUED LIABILITIES
As of December 31, 2022 and December 31, 2021, the accrued liabilities of the Company consisted of the following:
December 31, 2022 | December 31, 2021 | |||||||
Product development | $ | $ | ||||||
Accrued salaries and wages | ||||||||
Professional fees | ||||||||
Patent costs | ||||||||
Total accrued expenses | $ | $ |
NOTE 7. SHARE CAPITAL AND OTHER EQUITY INSTRUMENTS
Authorized Capital
On December 30, 2020, the Company amended its articles of incorporation to designate and authorize shares of preferred stock. The Company issued Series B preferred stock (“Series B Preferred Stock), which has a certificate of designation authorizing issuance of preferred shares. During the year ended December 31, 2021, holders of an aggregate of shares of Series B Preferred Stock converted their shares into shares of common stock. Following those conversions, Series B Preferred stock shares remain outstanding.
Series C Preferred Shares
On May 3, 2022, the Board of Directors (the “Board”) declared a dividend of one one-thousandth of a share of the Company’s Series C Preferred Stock (“Series C Preferred Stock”) for each outstanding share of the Company’s Common Stock (the “Common Stock”) held of record as of 5:00 p.m. Eastern Time on May 13, 2022 (the “Record Date”). This dividend was based on the number of outstanding shares of Common Stock prior to the Reverse Stock Split. The outstanding shares of Series C Preferred Stock were entitled to vote together with the outstanding shares of the Company’s Common Stock, as a single class, exclusively with respect to a proposal giving the Board the authority, as it determines appropriate, to implement a reverse stock split within twelve months following the approval of such proposal by the Company’s stockholders (the “Reverse Stock Split Proposal”), as well as any proposal to adjourn any meeting of stockholders called for the purpose of voting on the Reverse Stock Split Proposal (the “Adjournment Proposal”).
The
Company held a special meeting of stockholders on July 14, 2022 (the “Special Meeting”) for the purpose of voting on, among
other proposals, a Reverse Stock Split Proposal and an Adjournment Proposal. All shares of Series C Preferred Stock that were not present
in person or by proxy at the Special Meeting were automatically redeemed by the Company immediately prior to the opening of the polls
at Special Meeting (the “Initial Redemption”). All shares that were not redeemed pursuant to the Initial Redemption were
redeemed automatically upon the approval by the Company’s stockholders of the Reverse Stock Split Proposal at the Special Meeting
(the “Subsequent Redemption” and, together with the Initial Redemption, the “Redemption”).
Common Stock Activity
On
February 15, 2022, the Company completed a public offering of
F-26 |
ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
On
July 22, 2022, the Company entered into a securities purchase agreement (the “Registered Direct Securities Purchase Agreement”)
with an institutional investor for the purchase and sale of
Concurrently
with the RD Offering, the Company entered into a securities purchase agreement (the “PIPE Securities Purchase Agreement”)
with institutional investors for the purchase and sale of
The
RD offering and PIPE Offering closed on July 26, 2022, with aggregate gross proceeds of approximately $
During the year ended December 31, 2022, a total of and shares of Common Stock were issued pursuant to the conversion of restricted stock awards and restricted stock units, respectively.
On
January 14, 2021, the Company completed an offering of
On
February 11, 2021, the Company completed an offering of
On
September 16, 2021, the Company, in connection with the Amalgamation Agreement entered into on May 24, 2021, acquired MagicMed Industries
Inc., and its wholly owned subsidiary MagicMed USA, Inc. The Company issued a total of
During
the year ended December 31, 2021, a total of
During the year ended December 31, 2021, a total of Common Shares were issued pursuant to cashless exercise of options to purchase Common Stock.
During
the year ended December 31, 2021, a total of
During
the year ended December 31, 2021, the Company issued
During the year ended December 31, 2021, the Company issued a total of shares of Common Stock pursuant to exercise of put rights contained in warrants originally issued by Ameri and assumed by the Company.
Issuance and Conversion of Series B Preferred Shares
During the year ended December 31, 2021, the Company issued a total of shares of Common Stock pursuant to the conversion of shares of Series B Preferred Stock.
F-27 |
ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Stock Options
Amendment to 2020 Long-Term Incentive Plan
On May 3, 2022, our Board adopted the First Amendment (the “Plan Amendment”) to the Enveric Biosciences, Inc. 2020 Long-Term Incentive Plan (the “Incentive Plan”) to
Number of Shares | Weighted Average Exercise Price | Weighted Average Grant Date Fair Value | Weighted Average Remaining Contractual Term (years) | Aggregate Intrinsic Value | ||||||||||||||||
Outstanding at December 31, 2020 | $ | $ | $ | |||||||||||||||||
Granted | $ | $ | — | $ | — | |||||||||||||||
Options assumed pursuant to acquisition of MagicMed | $ | $ | — | $ | — | |||||||||||||||
Exercised | ( | ) | $ | $ | — | $ | — | |||||||||||||
Expired, forfeited, or cancelled | ( | ) | $ | $ | — | $ | — | |||||||||||||
Outstanding at December 31, 2021 | $ | $ | $ | |||||||||||||||||
Granted | $ | $ | — | — | ||||||||||||||||
Forfeited | ( | ) | $ | $ | — | — | ||||||||||||||
Outstanding at December 31, 2022 | $ | $ | $ | — | ||||||||||||||||
Exercisable at December 31, 2022 | $ | $ | $ | — |
During the years ended December 31, 2022 and 2021, options were exercised via a cashless exercise resulting in the issuance of and shares of common stock. and
December 31, 2022 | December 31, 2021 | |||||||
Term (years) | - | |||||||
Stock price | $ | $ - $ | ||||||
Exercise price | $ | $ - $ | ||||||
Dividend yield | % | % | ||||||
Expected volatility | % | % - | % | |||||
Risk free interest rate | % | % - | % |
F-28 |
ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
The above assumptions are determined by the Company as follows:
● | Stock price – Based on closing price of the Company’s common stock on the date of grant. |
● | Weighted average risk-free interest rate — Based on the daily yield curve rates for U.S. Treasury obligations with maturities, which correspond to the expected term of the Company’s stock options. |
● | Dividend yield — The Company has not paid any dividends on common stock since its inception and does not anticipate paying dividends on its common stock in the foreseeable future. |
● | Expected volatility — Based on the historical volatility of comparable companies in a similar industry. |
● | Expected term — The Company has had no stock options exercised since inception. The expected option term represents the period that stock-based awards are expected to be outstanding based on the simplified method provided in Staff Accounting Bulletin (“SAB”) No. 107, Share-Based Payment, which averages an award’s weighted-average vesting period and expected term for “plain vanilla” share options. |
The Company’s stock based compensation expense, recorded within general and administrative expense, related to stock options for the years ended December 31, 2022 and 2021 was $ and $ , respectively. As of December 31, 2022, the Company had $ in unamortized stock option expense, which will be recognized over a weighted average period of years.
During
the year ended December 31, 2021, the Company exchanged options to purchase
Restricted Stock Awards
Number of shares | Weighted average fair value | |||||||
Non-vested at December 31, 2020 | $ | |||||||
Granted | $ | |||||||
Vested | ( | ) | $ | |||||
Non-vested at December 31, 2021 | $ | |||||||
Forfeited | ( | ) | $ | |||||
Vested | ( | ) | $ | |||||
Non-vested at December 31, 2022 | $ |
For the years ended December 31, 2022 and 2021, the Company recorded $ and $ , respectively, in stock-based compensation expense within general and administrative expense, related to restricted stock awards. As of December 31, 2022, there were no unamortized stock-based compensation costs related to restricted share awards. The balance of Common Shares related to the vested restricted stock awards as of December 31, 2022 will be issued during the 2023 calendar year. There are vested and unissued shares of restricted stock awards as of December 31, 2022.
F-29 |
ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Issuance of Restricted Stock Units
The Company’s activity in restricted stock units was as follows for the year ended December 31, 2022:
Number of shares | Weighted average fair value | |||||||
Non-vested at December 31, 2020 | $ | |||||||
Granted | $ | |||||||
Forfeited | ( | ) | $ | |||||
Vested | ( | ) | $ | |||||
Non-vested at December 31, 2021 | $ | |||||||
Granted | $ | |||||||
Forfeited | ( | ) | $ | |||||
Vested | ( | ) | $ | |||||
Non-vested at December 31, 2022 | $ |
For the years ended December 31, 2022 and 2021, the Company recorded $ and $ , respectively, in stock-based compensation expense related to restricted stock units, which is a component of both general and administrative and research and development expenses in the consolidated statement of operations and comprehensive loss.
As of December 31, 2022, the Company had unamortized stock-based compensation costs related to restricted stock units of $ which will be recognized over a weighted average period of years and unamortized stock-based costs related to restricted stock units which will be recognized upon achievement of specified milestones.
As of December 31, 2022, shares of Common Stock have been issued in relation to vested restricted stock units and restricted stock units are vested without shares of Common Stock being issued.
Year ended December 31, | ||||||||
Stock-based compensation for RSUs | 2022 | 2021 | ||||||
General and administrative | $ | $ | ||||||
Research and development | ||||||||
Total | $ | $ |
As of the end of the fiscal years ended December 31, 2022 and 2021, there were and shares of common stock underlying outstanding restricted stock units, of which (i) and shares are underlying vested restricted stock units and issuable, subject to certain conditions for settlement, which includes either termination of employment with the Company or a change of control, and (ii) and shares are issuable upon the vesting of such restricted stock units, subject to achievement of vesting conditions, certain conditions of settlement which includes either termination of employment with the Company or a change of control, and further subject to the increase in the number of shares authorized for issuance of awards under the Long-Term Incentive Plan upon approval by the Company’s stockholders.
F-30 |
ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Warrants
The following table summarizes information about shares issuable under warrants outstanding at December 31, 2022 and 2021:
Warrant shares outstanding | Weighted average exercise price | Weighted average remaining life | Intrinsic value | |||||||||||||
Outstanding at December 31, 2020 | $ | $ | ||||||||||||||
Issued | $ | — | $ | — | ||||||||||||
Assumed pursuant to acquisition of MagicMed | $ | — | $ | — | ||||||||||||
Exercised | ( | ) | $ | — | $ | — | ||||||||||
Exchanged for common stock | ( | ) | $ | — | $ | — | ||||||||||
Outstanding at December 31, 2021 | $ | $ | ||||||||||||||
Issued | $ | — | $ | — | ||||||||||||
Exercised | ( | ) | $ | — | — | $ | — | |||||||||
Exchanged for common stock | — | $ | — | — | $ | — | ||||||||||
Outstanding at December 31, 2022 | $ | $ | ||||||||||||||
Exercisable at December 31, 2022 | $ | $ |
On
February 11, 2022, the Company entered into an underwriting agreement (the “Underwriting Agreement”) with A.G.P./Alliance
Global Partners (the “Underwriter”). Pursuant to the Underwriting Agreement, the Company agreed to sell, in a firm commitment
offering,
In
connection with the Registered Direct (“RD”) Offering and the Private Investment in Public Entity (“PIPE”) Offering
entered into on July 22, 2022, the Company entered into Warrant Amendment (the “Warrant Amendments”) with the investors in
both offerings to amend certain existing warrants to purchase up to an aggregate of
The warrants assumed pursuant to the acquisition of MagicMed contain certain down round features, which were not triggered by the February 2022 and July 2022 public offerings, that would require adjustment to the exercise price upon certain events when the offering price is less than the stated exercise price.
During
the year ended December 31, 2021, warrants exchanged for Common Stock consisted of an aggregate of
The aggregate of Common Shares issued in exchange for the aggregate of warrants issued by Ameri and containing put rights were issued in lieu of cash payments, in accordance with the terms of the put rights contained in the warrants.
The
aggregate of
F-31 |
ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Preferred Investment Options
In
connection with the Registered Direct Securities Purchase Agreement the Company issued unregistered preferred investment options to purchase
up to shares of common stock.Subject to certain
ownership limitations, the RD Preferred Investment Options became immediately exercisable
at an exercise price equal to $
In
connection with the PIPE Securities Purchase Agreement the Company issued unregistered preferred investment options to purchase up to
shares of the common stock. Subject to certain
ownership limitations, PIPE Preferred Investment Options became immediately exercisable
at an exercise price equal to $
On
July 26, 2022, in connection with the RD Offering and PIPE Offering, the Company issued preferred
investment options (the “Placement Agent Preferred Investment Options”) to an entity to purchase up to
The following table summarizes information about investment options outstanding at December 31, 2022 (there were no investment options issued for the year ended December 31, 2021):
Investment options outstanding | Weighted average exercise price | Weighted average remaining life | Intrinsic value | |||||||||||||
Outstanding at January 1, 2022 | $ | — | $ | |||||||||||||
Issued | $ | — | — | |||||||||||||
Outstanding at December 31, 2022 | $ | $ | ||||||||||||||
Exercisable at December 31, 2022 | $ | $ |
F-32 |
ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
NOTE 8. REDEEMABLE NON-CONTROLLING INTEREST
Spin-Off and Related Private Placement
In
connection with the planned Spin-Off, on May 5, 2022, Akos and the Company entered into the Akos Purchase Agreement with the Akos Investor,
pursuant to which Akos agreed to sell up to an aggregate of
Terms of Akos Series A Preferred Stock
Under
the Certificate of the Designations, Preferences and Rights of Series A Convertible Preferred Stock of Akos (the “Akos Series A
Preferred Certificate of Designations”), on or immediately prior to the completion of the spin-off of Akos into an independent,
separately traded public company listed on the Nasdaq Stock Market, the outstanding Akos Series A Preferred Stock will be automatically
converted into a number of shares of Akos Common Stock equal to
The Akos Series A Preferred Certificate of Designations provides that upon the earlier of (i) the one-year anniversary of May 5, 2022, and only in the event that the Spin-Off has not occurred; or (ii) such time that Akos and the Company have abandoned the Spin-Off or the Company is no longer pursuing the Spin-Off in good faith, the holders of the Akos Series A Preferred Stock shall have the right (the “Put Right”), but not the obligation, to cause Akos to purchase all or a portion of the Akos Series A Preferred Stock for a purchase price equal to $ per share, subject to certain adjustments as set forth in the Akos Series A Preferred Certificate of Designations (the “Stated Value”), plus all the accrued but unpaid dividends per share. In addition, after the one-year anniversary of May 5, 2022, and only in the event that the Spin-Off has not occurred and Akos is not in material default of any of the transaction documents, Akos may, at its option, at any time and from time to time, redeem the outstanding shares of Akos Series A Preferred Stock, in whole or in part, for a purchase price equal to the aggregate Stated Value of the shares of Akos Series A Preferred Stock being redeemed and the accrued and unpaid dividends on such shares. Pursuant to the Akos Purchase Agreement, the Company has guaranteed the payment of the purchase price for the shares purchased under the Put Right.
The Akos Series A Preferred Certificate of Designations contains limitations that prevent the holder thereof from acquiring shares of Akos Common Stock upon conversion of the Akos Series A Preferred Stock that would result in the number of shares of Akos Common Stock beneficially owned by such holder and its affiliates exceeding 9.99% of the total number of shares of Akos Common Stock outstanding immediately after giving effect to the conversion (the “Beneficial Ownership Limitation”), except that upon notice from the holder to Akos, the holder may increase or decrease the limit of the amount of ownership of outstanding shares of Akos Common Stock after converting the holder’s shares of Akos Series A Preferred Stock, provided that any change in the Beneficial Ownership Limitation shall not be effective until 61 days following notice to Akos.
F-33 |
ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Accounting for Akos Series A Preferred Stock
Since the shares of Akos Series A Preferred Stock are redeemable at the option of the holder and the redemption is not solely in the control of the Company, the shares of Akos Series A Preferred Stock are accounted for as a redeemable non-controlling interest and classified within temporary equity in the Company’s consolidated balance sheets. The redeemable non-controlling interest was initially measured at fair value. Dividends on the shares of Akos Series A Preferred Stock are recognized as preferred dividends attributable to redeemable non-controlling interest in the Company’s consolidated statement of operations and comprehensive loss.
The table below presents the reconciliation of changes in redeemable non-controlling interest:
Balance at December 31, 2021 | $ | |||
Redeemable
non-controlling interest, net of initial value embedded derivative of $ | ||||
Preferred dividends attributable to redeemable non-controlling interest | ||||
Accretion of embedded derivative and transaction costs associated with Series A Preferred Stock | ||||
Balance at December 31, 2022 | $ |
As
of December 31, 2022, the redemption value of the redeemable non-controlling interest is $
NOTE 9. COMMITMENTS AND CONTINGENCIES
The Company is periodically involved in legal proceedings, legal actions and claims arising in the normal course of business. Management believes that the outcome of such legal proceedings, legal actions and claims will not have a significant adverse effect on the Company’s financial position, results of operations or cash flows.
Development and Clinical Supply Agreement
On February 22, 2021, the Company entered into a Development and Clinical Supply Agreement (the “PureForm Agreement”) with PureForm Global, Inc. (“PureForm”), pursuant to which PureForm will be the exclusive provider of synthetic cannabidiol (“API”) for the Company’s development plans for cancer treatment and supportive care. Under the terms of the PureForm Agreement, PureForm has granted the Company the exclusive right to purchase API and related product for cancer treatment and supportive care during the term of the Agreement (contingent upon an initial minimum order of 1 kilogram during the first thirty (30) days from the effective date) and has agreed to manufacture, package and test the API and related product in accordance with specifications established by the parties. All inventions that are developed jointly by the parties in the course of performing activities under the PureForm Agreement will be owned jointly by the parties in accordance with applicable law; however, if the Company funds additional research and development efforts by PureForm, the parties may enter into a further agreement whereby PureForm would assign any resulting inventions or technical information to the Company.
The initial term of the PureForm Agreement is three (3) years commencing on the effective date of the PureForm Agreement, subject to extension by mutual agreement of the parties. The PureForm Agreement may be terminated by either party upon thirty (30) days written notice of an uncured material breach or immediately in the event of bankruptcy or insolvency. The PureForm Agreement contains, among other provisions, representation and warranties, indemnification obligations and confidentiality provisions in favor of each party that are customary for an agreement of this nature.
The Company has met the minimum purchase requirement of 1 kilogram during the first thirty days of the PureForm Agreement’s effectiveness.
F-34 |
ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Purchase agreement with Prof. Zvi Vogel and Dr. Ilana Nathan
On
December 26, 2017, Jay Pharma entered into a purchase agreement with Prof. Zvi Vogel and Dr. Ilana Nathan (the “Vogel-Nathan Purchase
Agreement”), pursuant to which Jay Pharma was assigned ownership rights to certain patents, which were filed and unissued as of
the date of the Vogel-Nathan Purchase Agreement. The Vogel-Nathan Purchase Agreement includes a commitment to pay a one-time milestone
totaling $
Agreement with Tikkun
License Agreement
On August 12, 2020, Jay Pharma, TO LLC and TOH entered into the First Amendment to the License Agreement, pursuant to which all references to the Original Amalgamation Agreement and the amalgamation were revised to be references to the Tender Agreement and the Offer, as applicable.
On October 2, 2020, Jay Pharma, TO LLC and TOH entered into the Second Amendment to the License Agreement, pursuant to which the effective date of the transactions was revised to occur as of October 2, 2020.
On December 30, 2022, the Tikun Olam License was formally terminated by mutual agreement between the Company and Tikun Olam.
Other Consulting and Vendor Agreements
The
Company has entered into a number of agreements and work orders for future consulting, clinical trial support, and testing services,
with terms ranging between 1 and 12 months. These agreements, in aggregate, commit the Company to approximately $
Right-of-use lease
On August 1, 2021, MagicMed entered into a lease agreement (the “LSIH Lease”) with the University of Calgary for the use and occupation of lab and office space at the University of Calgary’s Life Science Innovation Hub building located in Calgary, Alberta, Canada (the “LSIH Facility”). The Company acquired all rights and obligations contained in the LSIH Lease concurrent with its amalgamation with MagicMed.
The Company assesses whether an arrangement is a lease or contains a lease at inception. For arrangements considered leases or that contain a lease that is accounted for separately, the Company determines the classification and initial measurement of the right-of-use asset and lease liability at the lease commencement date, which is the date that the underlying asset becomes available for use. The Company has elected to account for non-lease components associated with its leases and lease components as a single lease component.
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ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
The Company recognizes a right-of-use asset, which represents the Company’s right to use the underlying asset for the lease term, and a lease liability, which represents the present value of the Company’s obligation to make payments arising over the lease term. The present value of the lease payments is calculated using either the implicit interest rate in the lease or an incremental borrowing rate.
Lease assets and liabilities are classified as follows on the consolidated balance sheet:
Lease | Classification | As of December 31, 2022 | As of December 31, 2021 | |||||||
Assets | ||||||||||
Operating | Right of use operating lease asset, net | $ | $ | |||||||
Total leased assets | $ | $ | ||||||||
Liabilities | ||||||||||
Current | ||||||||||
Operating | Current portion of right-of-use operating lease obligation | $ | $ | |||||||
Long-term | ||||||||||
Operating | Non-current portion of right-of-use operating lease obligation | |||||||||
Total lease liabilities | $ | $ |
Rent
expense is recorded on the straight-line basis. Rent expense under the LSIH Lease for the years ended December 31, 2022 and 2021 was
$
The table below shows the future minimum rental payments, exclusive of taxes, insurance, and other costs, under the LSIH Lease:
Years ending December 31, | Amount | |||
2023 | $ | |||
Total future minimum lease payments | ||||
Less: present value adjustment | ( | ) | ||
Present value of lease payments | $ |
The weighted-average remaining lease term and the weighted-average discount rate of the lease was as follows:
Lease Term and Discount Rate | December 31, 2022 | December 31, 2021 | ||||||
Remaining lease term (years) | ||||||||
Operating leases | ||||||||
Discount rate | ||||||||
Operating leases | % | % |
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ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
NOTE 10. INCOME TAXES
The Company’s U.S. and foreign loss before income taxes are set forth below:
December 31, | ||||||||
2022 | 2021 | |||||||
United States | $ | ( | ) | $ | ( | ) | ||
Foreign | ( | ) | ( | ) | ||||
Total | $ | ( | ) | $ | ( | ) |
For
the years ended December 31, 2022 and 2021, the Company recorded an income tax benefit of $
December 31, | ||||||||
2022 | 2021 | |||||||
Deferred tax benefit - United States | $ | $ | ||||||
Deferred tax benefit - Foreign | ||||||||
Total income tax benefit | $ | $ |
The Company’s deferred tax assets and deferred tax liabilities consist of the following:
December 31, | ||||||||
2022 | 2021 | |||||||
Deferred tax assets: | ||||||||
Net operating loss carryforwards | $ | $ | ||||||
Stock-based compensation | ||||||||
Accrued bonus | ||||||||
Research and development capitalized expenses | ||||||||
Intangible amortization | ||||||||
Other | ||||||||
Less valuation allowances | ( | ) | ( | ) | ||||
Net deferred tax assets | $ | $ | ||||||
Deferred tax liabilities: | ||||||||
Indefinite lived intangible assets | ( | ) | ||||||
Net deferred tax liabilities | $ | $ | ( | ) |
The Company had the following potentially utilizable net operating loss tax carryforwards:
December 31, | ||||||||
2022 | 2021 | |||||||
Federal | $ | $ | ||||||
State | $ | $ | ||||||
Foreign | $ | $ |
The
Tax Cuts and Jobs Act of 2017 (the “Act”) limits the net operating loss deduction to 80% of taxable income for losses arising
in tax years beginning after December 31, 2017. As of December 31, 2022, the Company had federal net operating loss carryforwards and
state net operating loss carryforwards of $
F-37 |
ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
The Company’s effective tax rate varied from the statutory rate as follows:
December 31, | ||||||||
2022 | 2021 | |||||||
Federal income tax at the statutory rate | ( | )% | ( | )% | ||||
State income tax rate (net of federal) | ( | )% | ( | )% | ||||
Foreign tax rate differential | ( | )% | ( | )% | ||||
Intangible asset impairment | % | % | ||||||
Non-deductive expenses | ( | )% | % | |||||
Change in valuation allowance | % | % | ||||||
Effective income tax rate | ( | )% | ( | )% |
On
September 16, 2021, the Company acquired MagicMed. In connection with the acquisition, the Company recorded intangible assets from
IPR&D valued at $
In
assessing the realizability of deferred tax assets, management considers whether it is more likely than not that some portion or all
of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of
future taxable income during the periods in which those temporary differences become deductible. The valuation allowance increased by
$
The Company files U.S. federal and state returns. The Company’s foreign subsidiary also files a local tax return in their local jurisdiction. From a U.S. federal, state and Canadian perspective the years that remain open to examination are consistent with each jurisdiction’s statute of limitations. As of March 30, 2023, the Company has not filed tax returns for the fiscal years 2022 and 2021.
Section 382
The utilization of the Company’s net operating losses may be subject to a substantial limitation in the event of any significant future changes in its ownership structure under Section 382 of the Internal Revenue Code and similar state provisions. Such limitation may result in the expiration of the net operating loss carryforwards before their utilization.
Section 174
Beginning in 2022, the Tax Cuts and Jobs Act of 2017 (“TCJA”)
eliminated the option to deduct research and development expenditures in the current year and requires taxpayers to amortize US expenses
over five years and foreign expense over fifteen years pursuant to IRC Section 174. The Company has estimated and capitalized gross $
Inflation Reduction Act
On August 16, 2022, President Joe Biden signed the Inflation Reduction Act of 2022 (the “Act”) into law. The Act includes a new 15% corporate minimum tax and a 1% excise tax on the value of corporate stock repurchases, net of new share issuances, after December 31, 2022. The Company does not expect these provisions to have a material impact on the Company’s consolidated financial position; however, the Company will continue to evaluate their impact as further information becomes available.
NOTE 11. SUBSEQUENT EVENTS
Australian Subsidiary
On March 21, 2023, the Company established Enveric Therapeutics, Pty. Ltd. (“Enveric Therapeutics”), an Australia-based subsidiary, to support the Company’s plans to advance its EVM201 Series towards the clinic. Enveric Therapeutics will oversee the Company’s preclinical, clinical, and regulatory activities in Australia, including ongoing interactions with the local Human Research Ethics Committees (HREC) and the Therapeutic Goods Administration (TGA), Australia’s regulatory authority.
On
March 23, 2023, the Company issued a press release announcing the selection of Australian CRO, Avance Clinical, in preparation for
Phase 1 Study of EB-373, the Company’s lead candidate targeting the treatment of anxiety disorders. The Phase 1 clinical trial
is expected to initiate in the fourth quarter of 2023. Under the agreement, Avance Clinical will manage the Phase 1 clinical trial
of EB-373 in coordination with the Company’s newly established Australian subsidiary, Enveric Therapeutics Pty, Ltd. The Phase
1 clinical trial is designed as a multi-cohort, dose-ascending study to measure the safety and tolerability of EB-373. EB-373, a
next-generation proprietary psilocin prodrug, has been recognized as a New Chemical Entity (NCE) by Australia’s Therapeutic
Goods Administration (TGA) and is currently in preclinical development targeting the treatment of anxiety disorder. The total cost
of the Avance Clinical contract is approximately
F-38 |