UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
☒
Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
For
the quarterly period ended: June 30, 2023
OR
☐
Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
For
the transition period from ___ to ___
Commission
File Number 001-38286
ENVERIC
BIOSCIENCES, INC.
(Exact
name of registrant as specified in its charter)
Delaware
95-4484725
(State
or other jurisdiction of
incorporation
or organization)
(IRS
Employer
Identification
No.)
4851
Tamiami Trail N , Suite 200 Naples , FL
34103
(Address
of principal executive offices)
(Zip
code)
(239)
302-1707
(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
Common
Stock, $0.01 par value per share
ENVB
The
Nasdaq Stock Market LLC
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (Section 232.405 of this chapter) during the preceding 12 months (or such shorter period that the registrant was
required to submit such files). Yes ☒ No ☐
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 ☐
Non-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 is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
As
of August 9, 2023, there were 2,147,906 shares outstanding of Registrant’s Common Stock (par value $0.01 per share).
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
FORM
10-Q
TABLE
OF CONTENTS
Page
PART I - FINANCIAL INFORMATION
Item 1.
Financial Statements
Condensed Consolidated Balance Sheets as of June 30, 2023 (Unaudited) and December 31, 2022
1
Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss for the three and six months ended June 30, 2023 and 2022
2
Unaudited Condensed Consolidated Statements of Changes in Mezzanine Equity and Shareholders’ Equity for the three and six months ended June 30, 2023 and 2022
3
Unaudited Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2023 and 2022
5
Notes to Unaudited Condensed Consolidated Financial Statements
6
Item 2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
20
Item 3.
Quantitative and Qualitative Disclosures About Market Risk
28
Item 4.
Controls and Procedures
28
PART II - OTHER INFORMATION
Item 1.
Legal Proceedings
29
Item 1A.
Risk Factors
29
Item 2.
Unregistered Sales of Equity Securities and Use of Proceeds
29
Item 3.
Defaults Upon Senior Securities
29
Item 4.
Mine Safety Disclosures
29
Item 5.
Other Information
29
Item 6.
Exhibits
29
Signatures
30
1
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED BALANCE SHEETS
June 30, 2023
December
31,2022
(unaudited)
ASSETS
Current assets:
Cash
$ 7,081,408
$ 17,723,884
Prepaid expenses and other current assets
1,818,611
708,053
Total current assets
8,900,019
18,431,937
Other assets:
Property and equipment, net
595,233
677,485
Right-of-use operating lease asset
9,607
63,817
Intangible assets, net
295,311
379,686
Total other assets
900,151
1,120,988
Total assets
$ 9,800,170
$ 19,552,925
LIABILITIES, MEZZANINE EQUITY, AND SHAREHOLDERS’ EQUITY
Current liabilities:
Accounts payable
$ 1,234,490
$ 463,275
Accrued liabilities
1,499,476
1,705,655
Current portion of right-of-use operating lease obligation
9,611
63,820
Investment option liability
1,813,644
851,008
Warrant liability
368,379
185,215
Derivative liability
—
727,000
Total current liabilities
$ 4,925,600
$ 3,995,973
Commitments and contingencies (Note 9)
-
-
Mezzanine equity
Series C redeemable preferred stock, $ 0.01 par value, 100,000 shares authorized, and 0 shares issued and outstanding as of June 30, 2023 and December 31, 2022
—
—
Redeemable non-controlling interest
—
885,028
Total mezzanine equity
—
885,028
Shareholders’ equity
Preferred stock, $ 0.01 par value, 20,000,000 shares authorized; Series B preferred stock, $ 0.01 par value, 3,600,000 shares authorized, 0 shares issued and outstanding as of June 30, 2023 and December 31, 2022
—
—
Common stock, $ 0.01 par value, 100,000,000 shares authorized, 2,141,782 and 2,078,271 shares issued and outstanding as of June 30, 2023 and December 31, 2022, respectively
21,417
20,782
Additional paid-in capital
95,640,571
94,395,662
Accumulated deficit
( 90,241,366 )
( 79,207,786 )
Accumulated other comprehensive loss
( 546,052 )
( 536,734 )
Total shareholders’ equity
4,874,570
14,671,924
Total liabilities, mezzanine equity, and shareholders’ equity
$ 9,800,170
$ 19,552,925
See the accompanying notes to the unaudited condensed
consolidated financial statements.
1
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
UNAUDITED
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
2023
2022
2023
2022
For the Three Months Ended June 30,
For the Six Months Ended June 30,
2023
2022
2023
2022
Operating expenses
General and administrative
$ 3,155,400
$ 2,501,206
$ 5,910,991
$ 5,269,072
Research and development
2,513,089
2,120,051
4,531,690
4,078,765
Depreciation and amortization
86,518
85,502
173,004
154,767
Total operating expenses
5,755,007
4,706,759
10,615,685
9,502,604
Loss from operations
( 5,755,007 )
( 4,706,759 )
( 10,615,685 )
( 9,502,604 )
Other income (expense)
Change in fair value of warrant liabilities
( 233,821 )
1,969,922
( 183,164 )
2,245,891
Change in fair value of investment option liability
( 1,082,141 )
—
( 962,636 )
—
Change in fair value of derivative liability
714,000
( 53,000 )
727,000
( 53,000 )
Interest income (expense)
916
( 668 )
905
( 4,806 )
Total other (expense) income
( 601,046 )
1,916,254
( 417,895 )
2,188,085
Net loss
( 6,356,053 )
( 2,790,505 )
( 11,033,580 )
( 7,314,519 )
Less preferred dividends attributable to non-controlling interest
6,712
7,808
19,041
7,808
Less deemed dividends attributable to accretion of embedded derivative at redemption value
36,997
73,994
147,988
73,994
Net loss attributable to shareholders
( 6,399,762 )
( 2,872,307 )
( 11,200,609 )
( 7,396,321 )
Other comprehensive loss
Foreign currency translation
( 11,286 )
( 281,014 )
( 9,318 )
( 192,305 )
Comprehensive loss
$ ( 6,411,048 )
$ ( 3,153,321 )
$ ( 11,209,927 )
$ ( 7,588,626 )
Net loss per share - basic and diluted
$ ( 3.04 )
$ ( 2.73 )
$ ( 5.35 )
$ ( 7.78 )
Weighted average shares outstanding, basic and diluted
2,107,583
1,053,760
2,093,008
951,193
See the accompanying notes to the unaudited condensed consolidated financial statements.
2
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
UNAUDITED
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN MEZZANINE EQUITY AND SHAREHOLDERS’ EQUITY
FOR
THE THREE AND SIX MONTHS ENDED JUNE 30, 2023 AND 2022
-
Shares
Amount
Equity
Shares
Amount
Capital
Deficit
Loss
Equity
Redeemable
Non-controlling Interest
Total Mezzanine
Common
Stock
Additional Paid-In
Accumulated
Accumulated Other
Comprehensive
Total
Shareholders’
Shares
Amount
Equity
Shares
Amount
Capital
Deficit
Loss
Equity
Balance at January 1, 2023 -
1,000
$ 885,028
$ 885,028
2,078,271
$ 20,782
$ 94,395,662
$ ( 79,207,786 )
$ ( 536,734 )
$ 14,671,924
Stock-based compensation
—
—
—
—
—
532,835
—
—
532,835
Preferred dividends attributable to redeemable non-controlling
interest
—
12,329
12,329
—
—
( 12,329 )
—
—
( 12,329 )
Accretion of embedded derivative to redemption value
—
110,991
110,991
—
—
( 110,991 )
—
—
( 110,991 )
Foreign exchange translation gain
—
—
—
—
—
—
—
1,968
1,968
Net loss -
—
—
—
—
—
—
( 4,677,527 )
—
( 4,677,527 )
Balance at March 31, 2023 -
1,000
$ 1,008,348
$ 1,008,348
2,078,271
$ 20,782
$ 94,805,177
$ ( 83,885,313 )
$ ( 534,766 )
$ 10,405,880
Stock-based compensation
—
—
—
—
—
879,738
—
—
879,738
Preferred dividends attributable to redeemable
—
6,712
6,712
—
—
( 6,712 )
—
—
( 6,712 )
Accretion of embedded derivative to redemption value
—
36,997
36,997
—
—
( 36,997 )
—
—
( 36,997 )
Redemption of Series A preferred stock
( 1,000 )
( 1,052,057 )
( 1,052,057 )
—
—
—
—
—
—
Issuance of common shares in exchange for RSU conversions
from the reduction in force
—
—
—
63,511
635
( 635 )
—
—
—
Foreign exchange translation loss
—
—
—
—
—
—
—
( 11,286 )
( 11,286 )
Net loss -
—
—
—
—
—
—
( 6,356,053 )
—
( 6,356,053 )
Balance at June 30, 2023 -
—
$ —
$ —
2,141,782
$ 21,417
$ 95,640,571
$ ( 90,241,366 )
$ ( 546,052 )
$ 4,874,570
See the accompanying notes to the unaudited condensed consolidated financial statements.
3
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
UNAUDITED
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN MEZZANINE EQUITY AND SHAREHOLDERS’ EQUITY
FOR
THE THREE AND SIX MONTHS ENDED JUNE 30, 2023 AND 2022
Shares
Amount
Shares
Amount
Equity
Shares
Amount
Capital
Deficit
Income
(Loss)
Equity
Series
C Preferred Stock
Redeemable
Non-controlling Interest
Total Mezzanine
Common
Stock
Additional Paid-In
Accumulated
Accumulated Other
Comprehensive
Total
Shareholders’
Shares
Amount
Shares
Amount
Equity
Shares
Amount
Capital
Deficit
Income
(Loss)
Equity
Balance at January 1, 2022
—
$ —
—
$ —
—
651,921
$ 6,519
$ 83,066,656
$ ( 60,736,453 )
$ ( 30,802 )
$ 22,305,920
February 2022 registered direct offering
—
—
—
—
—
400,000
4,000
5,798,464
—
—
5,802,464
Stock-based compensation
—
—
—
—
—
—
—
768,619
—
—
768,619
Conversion of RSUs into common shares
—
—
—
—
—
899
9
( 9 )
—
—
—
Foreign exchange translation gain
—
—
—
—
—
—
—
—
—
88,709
88,709
Net loss
—
—
—
—
—
—
—
—
( 4,524,014 )
—
( 4,524,014 )
Balance at March 31, 2022
—
$ —
—
$ —
$ —
1,052,820
$ 10,528
$ 89,633,730
$ ( 65,260,467 )
$ 57,907
$ 24,441,698
Stock-based compensation
—
—
—
—
—
—
—
677,543
—
—
677,543
Redeemable non-controlling interest, net of $ 402,000
—
—
1,000
556,038
556,038
—
—
—
—
—
—
Issuance of redeemable non-controlling Series C
52,865
527
—
—
527
—
—
( 527 )
—
—
( 527 )
Preferred dividends attributable to redeemable non-controlling
interest
—
—
—
7,808
7,808
—
—
( 7,808 )
—
—
( 7,808 )
Accretion of embedded derivative to redemption
—
—
—
73,994
73,994
—
—
( 73,994 )
—
—
( 73,994 )
Conversion of RSAs into common shares
—
—
—
—
—
1,223
12
( 12 )
—
—
—
Foreign exchange translation gain
—
—
—
—
—
—
—
—
—
( 281,014 )
( 281,014 )
Net loss
—
—
—
—
—
—
—
—
( 2,790,505 )
—
( 2,790,505 )
Balance at June 30, 2022
52,865
$ 527
1,000
$ 637,840
$ 638,367
1,054,043
$ 10,540
$ 90,228,932
$ ( 68,050,972 )
$ ( 223,107 )
$ 21,965,393
See the accompanying notes to the unaudited condensed consolidated financial statements.
4
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
UNAUDITED
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
2023
2022
For the Six Months Ended June 30,
2023
2022
Cash Flows From Operating Activities:
Net loss
$ ( 11,033,580 )
$ ( 7,314,519 )
Adjustments to reconcile net loss to cash used in operating activities
Change in fair value of warrant liability
183,164
( 2,245,891 )
Change in fair value of investment option liability
962,636
—
Change in fair value of derivative liability
( 727,000 )
53,000
Stock-based compensation
1,412,573
1,446,162
Amortization of right-of-use asset
54,703
68,910
Amortization of intangible assets
84,375
84,375
Depreciation expense
88,629
70,392
Gain on disposal of property and equipment
( 4,212
)
—
Change in operating assets and liabilities:
Prepaid expenses and other current assets
( 1,111,913 )
( 1,031,979 )
Accounts payable and accrued liabilities
542,397
( 187,902 )
Right-of-use operating lease liability
( 54,702 )
( 76,686 )
Net cash used in operating activities
( 9,602,930 )
( 9,134,138 )
Cash Flows From Investing Activities:
Purchases of property and equipment
( 5,187 )
( 559,398 )
Proceeds from disposal of property and equipment
16,872
—
Net cash used in investing activities
11,685
( 559,398 )
Cash Flows From Financing Activities:
Proceeds from sale of common stock, warrants, and investment options, net of offering costs
—
9,397,884
Redemption of Series A Preferred Stock (see Note 8)
( 1,052,057 )
—
Proceeds from the sale of redeemable non-controlling interest, net of offering
—
958,038
Net cash (used in) provided by financing activities
( 1,052,057 )
10,355,922
Effect of foreign exchange rate on cash
826
( 9,434 )
Net (decrease) increase in cash
( 10,642,476 )
652,952
Cash at beginning of period
17,723,884
17,355,999
Cash at end of period
$ 7,081,408
$ 18,008,951
Supplemental disclosure of cash and non-cash transactions:
Cash paid for interest
$ 11
$ 4,806
Income taxes paid
$ —
$ —
Warrants issued in conjunction with common stock issuance
$ —
$ 3,595,420
Issuance of embedded derivative
$ —
$ 402,000
Issuance of redeemable non-controlling Series C preferred stock
$ —
$ 527
Preferred dividends attributable to redeemable non-controlling interest
$ 19,041
$ 7,808
Accretion of embedded derivative to redemption value
$ 147,988
$ 73,994
See the accompanying notes to the unaudited condensed consolidated financial statements.
5
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED 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”), Enveric Canada, and Enveric Therapeutics, Pty. Ltd. (“Enveric Therapeutics”).
MagicMed
develops and commercializes psychedelic-derived pharmaceutical candidates. MagicMed’s Psychedelic Derivatives (as defined below)
library, the Psybrary™, is an essential building block from which the industry can develop new patented products. The initial focus
of the Psybrary™ is on psilocybin and N-dimethyltry (“DMT”) derivatives, and it is then expected to be expanded
to other psychedelics.
Following
the Company’s amalgamation with MagicMed completed in September 2021 (the “Amalgamation”), the Company has continued
to pursue the development of MagicMed’s proprietary Psychedelic Derivatives library, the Psybrary™ which the Company believes
will help to identify and develop the right drug candidates needed to address mental health challenges, including cancer-related distress.
The Company synthesizes novel versions of classic psychedelics, such as psilocybin, DMT, mescaline and MDMA, using a mixture of chemistry
and synthetic biology, resulting in the expansion of the Psybrary™, which includes 15 patent families with over a million potential
variations and hundreds of synthesized molecules. Within the Psybrary™ the Company has three different types of molecules, Generation
1 (classic psychedelics), Generation 2 (pro-drugs), and Generation 3 (new chemical entities). The Company is working to add novel psychedelic
molecular compounds and derivatives (“Psychedelic Derivatives”) on a regular basis through its work at the Company’s
labs in Calgary, Alberta, Canada, where the Company has a team of PhD scientists with expertise in synthetic biology and chemistry. To
date the Company has created over 500 molecules that are housed in the Psybrary™.
The
Company screens newly synthesized molecules in the Psybrary™ through PsyAI™, a proprietary artificial intelligence (“AI”)
tool. Leveraging AI systems is expected to reduce the time and cost of pre-clinical, clinical, and commercial development. The Company
believes it streamlines pharmaceutical design by predicting ideal binding structures of molecules, manufacturing capabilities, and pharmacological
effects to help determine ideal drug candidates, tailored to each indication. Each of these molecules that the Company believes are patentable
can then be further screened to see how changes to its makeup alter its effects in order to synthesize additional new molecules. New
compounds of sufficient purity are undergoing pharmacological screening, including non-clinical (receptors/cell lines), preclinical (animal),
and ultimately clinical (human) evaluations. The Company intends to utilize the Psybrary™ and the AI tool to categorize and characterize
the Psybrary™ substituents to focus on bringing more psychedelics-inspired molecules from discovery to the clinical phase.
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”). As of May 12, 2023,
the holders of the Company’s Akos Series A Preferred Stock, par value $ 0.01 per share (“Akos Series A Preferred Stock”)
have exercised this right to force redemption of all of the Akos Series A Preferred Stock for $ 1,000 per share, plus accrued but unpaid
dividends of $ 52,057 for a total of $ 1,052,057 . The Company made full payment on May 19, 2023. See Note 8.
Reverse
Stock Split
On
July 14, 2022, the Company effected a 1-for-50 reverse stock split . All historical share and per share amounts reflected throughout this
report have been adjusted to reflect the reverse stock split.
Australian
Subsidiary
On March 21, 2023, the Company
established Enveric Therapeutics, an Australia-based subsidiary, to support the Company’s plans to advance its lead program, the
EVM201 Series, comprised of the next generation synthetic prodrugs of the active metabolite, psilocin (“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.
6
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Going
Concern, Liquidity and Other Uncertainties
The Company has incurred a loss since inception resulting in an accumulated
deficit of $ 90,241,366 as of June 30, 2023, and further losses are anticipated in the development of its business. Further, the Company
has operating cash outflows of $ 9,602,930 for the six months ended June 30, 2023. For the six months ended June 30, 2023, the Company
had a loss from operations of $ 10,615,685 . Since its inception, being a research and development company, the Company has not yet generated
revenue and the Company has incurred continuing losses from its operations. The Company’s operations have been funded principally
through the issuance of debt and equity. These factors raise substantial doubt about the Company’s ability to continue as a going
concern for a period of one year from the issuance of these 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 June 30, 2023, the Company had cash
of $ 7,081,408 and
working capital of $ 3,974,419 .
The Company’s current cash on hand is not sufficient enough to satisfy its operating cash needs for the 12 months from the filing
of this Quarterly Report on Form 10-Q. These conditions raise substantial doubt regarding the Company’s ability to continue as
a going concern for a period of one year after the date the financial statements are issued. Management’s plan to alleviate the
conditions that raise substantial doubt include reducing the Company’s rate of spend, managing its cash flow, advancing its programs,
and raising additional working capital through public or private equity or debt financings or other sources, which may include collaborations
with third parties as well as disciplined cash spending, to increase the Company’s cash runway. Adequate additional financing may
not be available to us on acceptable terms, or at all. Should the Company be unable to raise sufficient additional capital, the Company
may be required to undertake cost-cutting measures including delaying or discontinuing certain operating activities.
The
Company’s material cash requirements consist of working capital to fund capital expenditures incurred at their research facility
in Calgary and their operations, which consist primarily of, without limitation, employee related expenses, product development activities
conducted by third parties, research materials and lab supplies, facility related expenses including rent and maintenance, costs associated
with preclinical studies, patent related costs, costs of regulatory and public company compliance, insurance costs, audit costs, consultants
and legal fees. Additionally, the Company currently utilizes third-party contract CROs to assist with clinical development activities.
If the Company obtains regulatory approval for any of their product candidates, they expect to incur significant expenses to engage third-party
contract CMOs to carry out their clinical manufacturing activities as they do not yet have a commercial organization, and incur significant
expenses related to developing their internal commercialization capability to support product sales, marketing and distribution. The
Company’s current working capital resources are not sufficient to fund these material cash requirements for the next twelve months.
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 unaudited condensed
consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Reduction
in Force/Restructuring
In
May 2023, the Company entered into a cost reduction plan, including a reduction in force of approximately 35 %
of its full-time employees to streamline its operations and conserve cash resources. Additionally, contracts with seven consultants
that were focused on the Akos cannabinoid spin-out will be terminated. The Company recognized severance charges of approximately
$ 453,059 through June
30, 2023. The plan included a focus on progressing the Company’s existing non-cannabinoid pipeline while reducing the rate of
spend and managing cash flow. As of June 30, 2023, the Company has completed the reduction in force, with such severance expenses
recorded in general and administrative accounts.
On
June 16, 2023, the Company entered into a separation agreement with Avani Kanubaddi, the Company’s President and Chief
Operating Officer (the “Kanubaddi Separation Agreement”). In accordance with the Kanubaddi Separation Agreement, Mr.
Kanubaddi’s outstanding restricted stock units (“RSUs”) will retain their vesting conditions. Mr.
Kanubaddi’s 2023 salary and benefits of $ 464,468
was accrued and will be paid out in twelve equal monthly installments beginning in July 2023. Upon termination, any unvested
time-based RSUs became fully vested. The Company accelerated expense recognized related to these shares that vested was $ 231,273 . Of
the 11,278
market performance-based RSUs previously granted, 3,759
will continue to be subject to the original terms and conditions of Mr. Kanubaddi’s employment agreement and the remainder were forfeited.
7
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
SCHEDULE
OF RESTRUCTURING COSTS PAYABLE
Restructuring Costs Payable
January 1, 2023 Beginning balance
$ —
Restructuring costs incurred
917,527
Restructuring costs paid
( 190,808 )
June 30, 2023 ending balance
$ 726,719
Inflation
Risks
The
Company considers the current inflationary trend existing in the North American economic environment 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 in the cost of labor and materials. In addition, there is an increased risk of the Company
experiencing labor shortages due to a potential inability to attract and retain human resources due to increased labor costs resulting
from the current inflationary environment.
NOTE
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis
of Presentation and Principal of Consolidation
The
accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally
accepted in the United States (“U.S. GAAP”) for interim financial information and Article 8 of Regulation S-X. Accordingly,
they do not include all the information and footnotes required by U.S. GAAP for complete financial statements. Management’s opinion
is that all adjustments (consisting of normal accruals) considered necessary for a fair presentation have been included. Operating results
for the three and six months ended June 30, 2023 are not necessarily indicative of the results that may be expected for the year ending
December 31, 2023. These unaudited condensed consolidated financial statements should be read in conjunction with the consolidated financial
statements for the year ended December 31, 2022, and related notes thereto included in the Company’s Annual Report on Form 10-K
filed with the Securities and Exchange Commission (the “SEC”) on March 31, 2023 and subsequently amended on Form 10-K/A Amendment
No. 1 filed with the SEC on June 9, 2023 (as amended, the “Annual Report”).
The
Company’s significant accounting policies and recent accounting standards are summarized in Note 2 of the Company’s consolidated
financial statements for the year ended December 31, 2022. There were no significant changes to these accounting policies during the
three and six months ended June 30, 2023.
Use
of Estimates
The
preparation of the unaudited condensed 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, and estimated fair values of long lived assets used to record
impairment charges related to intangible assets. Actual results could differ from those estimates.
Foreign
Currency Translation
From
inception through June 30, 2023, the reporting currency of the Company was the United States dollar while the functional currency of
certain of the Company’s subsidiaries were the Canadian dollar and Australian dollar. For the reporting periods ended June 30,
2023 and 2022, the Company engaged in a number of transactions denominated in Canadian dollars and Australian dollars. As a result, the
Company is subject to exposure from changes in the exchange rates of the Canadian dollar and Australian dollar against the United States
dollar.
The
Company translates the assets and liabilities of its Canadian subsidiaries and Australian subsidiary into the United States 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 condensed consolidated statements of shareholders’ equity as a component of accumulated other comprehensive loss.
8
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
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 loss in the condensed consolidated statements
of operations and comprehensive loss as incurred.
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 $ 250,000 in the United States and Australia and $ 100,000 in Canada.
The Company has not experienced losses on these accounts, and management believes the Company is not exposed to significant risks on
such accounts. As of June 30, 2023, the Company had greater than $ 250,000 at United States financial institutions.
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 “Distinguishing
Liabilities from Equity” (“ASC 480”) and FASB ASC Topic 815, “Derivatives and Hedging” (“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 unaudited condensed 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 unaudited condensed consolidated balance sheet date and any change in fair value is recognized as a component
of other expense on the unaudited condensed 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.
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 unaudited condensed consolidated statements of operations. 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 unaudited condensed 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.
Income
Taxes
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.
9
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Net
Loss per Share
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 three and six months ended June 30, 2023 and 2022
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 “Earnings per Share” (“ASC 260”), penny warrants were included
in the calculation of weighted average shares outstanding for the purposes of calculating basic and diluted earnings per share.
Potentially
dilutive securities outlined in the table below have been excluded from the computation of diluted net loss per share the three and six
months ended June 30, 2023 and 2022 because the effect of their inclusion would have been anti-dilutive.
SCHEDULE
OF POTENTIALLY DILUTIVE SECURITIES
For the three and six months ended June 30, 2023
For
the three and six months ended June 30, 2022
Warrants to purchase shares of common stock
655,463
655,463
Restricted stock units - vested and unissued
55,622
56,071
Restricted stock units - unvested
180,115
94,550
Restricted stock awards - vested and unissued
708
909
Restricted stock awards - unvested
—
65
Investment options to purchase shares of common stock
1,070,000
—
Options to purchase shares of common stock
36,579
22,829
Total potentially dilutive securities
1,998,487
829,887
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.
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 June 30,
2023, and December 31, 2022 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 sheet as of
June 30, 2023, and December 31, 2022, 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:
10
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
SCHEDULE
OF FAIR VALUE HIERARCHY OF VALUATION INPUTS ON RECURRING BASIS
Level
June 30, 2023
December 31, 2022
Warrant liabilities - January 2021 Warrants
3
$ 145
$ 81
Warrant liabilities - February 2021 Warrants
3
147
79
Warrant liabilities - February 2022 Warrants
3
368,087
185,055
Fair value of warrant liability
$ 368,379
$ 185,215
Level
June 30, 2023
December 31, 2022
Derivative liability - May 2022
3
$ —
$ 727,000
Fair value of derivative liability
$ —
$ 727,000
Level
June 30, 2023
December 31, 2022
H.C. Wainwright & Co., LLC investment options
3
$ 84,812
$ 44,904
RD investment options
3
648,312
302,289
PIPE investment options
3
1,080,520
503,815
Fair value of investment option liability
$ 1,813,644
$ 851,008
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.
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:
SCHEDULE
OF FAIR VALUE OF WARRANT LIABILITIES AND DERIVATIVE LIABILITY AND INVESTMENT OPTIONS
Total Warrant Liabilities
Fair value as of December 31, 2022
$ 185,215
Change in fair value
183,164
Fair value as of June 30, 2023
$ 368,379
Total Derivative Liability
Fair value as of December 31, 2022
$ 727,000
Change in fair value arising from redemption of Akos Series A Preferred Stock - See Note 8
( 727,000 )
Fair value of derivative liability as of June 30, 2023
$ —
Total Investment Option Liability
Fair value as of December 31, 2022
$ 851,008
Change in fair value
962,636
Fair value of investment option liability as of June 30, 2023
$ 1,813,644
11
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
The
key inputs into the Black Scholes valuation model for the Level 3 valuations of the warrant liabilities as of June 30, 2023 are below:
SCHEDULE
OF BLACK SCHOLES VALUATION MODELS OF WARRANT LIABILITIES AND INVESTMENT OPTIONS
January 2021
Warrants
February 2021 Warrants
February 2022 Warrants
February 2022 Post-Modification Warrants
Term (years)
2.5
2.6
3.6
4.6
Stock price
$ 3.37
$ 3.37
$ 3.37
$ 3.37
Exercise price
$ 247.50
$ 245.00
$ 27.50
$ 7.78
Dividend yield
— %
— %
— %
— %
Expected volatility
80.0 %
79.0 %
76.0 %
87.0 %
Risk free interest rate
4.70 %
4.60 %
4.40 %
4.20 %
Number of warrants
36,429
34,281
338,000
122,000
Value (per share)
$ —
$ —
$ 0.45
$ 1.78
The
key inputs into the Black Scholes valuation model for the Level 3 valuations of the investment options as of June 30, 2023 are below:
H.C. Wainwright & Co., LLC Options
RD Offering Options
PIPE Offering Options
Term (years)
4.1
4.6
4.6
Stock price
$ 3.37
$ 3.37
$ 3.37
Exercise price
$ 10.00
$ 7.78
$ 7.78
Dividend yield
— %
— %
— %
Expected volatility
77.0 %
85.0 %
85.0 %
Risk free interest rate
4.30 %
4.20 %
4.20 %
Number of investment options
70,000
375,000
625,000
Value (per share)
$ 1.21
$ 1.73
$ 1.73
The
key inputs into the Weighted Expected Return valuation model for the Level 3 valuations of the derivative liability as of redemption,
are below:
May 2022 Derivative Liability
Principal
$ —
Dividend rate
— %
Market rate
— %
At
the date of the redemption of the of Akos Series A Preferred Stock in May 2023, the derivative liability fair value was $0 due to the
probability of a spin-off occurring was zero. See Note 8
Redeemable
Non-controlling Interest
In
connection with the issuance of Akos Series A Preferred Stock, the Akos Purchase Agreement (as defined below in Note 8) 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 mezzanine equity within its unaudited condensed 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.
In
May 2023, pursuant to the Akos Series A Preferred Certificate of Designations, the holders of the Akos Series A Preferred Stock exercised
the Put Right (as defined below) requiring Akos to force redemption of all of the Akos Series A Preferred Stock. See Note 8.
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.
12
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
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, 2023, 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 early adopted ASU 2020-06 effective January 1, 2023, and has determined that the adoption of this
guidance had no impact on its condensed consolidated financial statements.
NOTE
3. PREPAID EXPENSES AND OTHER CURRENT ASSETS
As
of June 30, 2023 and December 31, 2022, the prepaid expenses and other current assets of the Company consisted of the following:
Schedule
of Prepaid Expenses and Other Current Assets
June 30, 2023
December 31, 2022
Prepaid research and development
$ 998,866
$ 268,686
Prepaid value-added taxes
222,330
159,782
Prepaid insurance
511,042
174,406
Prepaid other
86,373
105,179
Total prepaid expenses and other current assets
$ 1,818,611
$ 708,053
NOTE
4. INTANGIBLE ASSETS
As
of June 30, 2023, the Company’s intangible assets consisted of:
SCHEDULE
OF FINITE LIVED INTANGIBLE ASSETS
Definite lived intangible assets
Balance at December 31, 2022
$ 379,686
Amortization
( 84,375 )
Balance at June 30, 2023
$ 295,311
For
identified definite lived intangible assets, there was no impairment expense during the three and six months ended June 30, 2023 and
2022. For identified definite lived intangible assets, amortization expense amounted to $ 42,187 during the three months ended June 30,
2023, and 2022, respectively. For identified definite lived intangible assets, amortization expense amounted to $ 84,375 during each of
the six months ended June 30, 2023 and 2022.
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:
SCHEDULE OF PROPERTY PLANT AND EQUIPMENT NET OF ACCUMULATED DEPRECIATION
June 30, 2023
December 31, 2022
Lab equipment
$ 834,288
$ 831,123
Computer equipment and leasehold improvements
28,349
25,137
Less: Accumulated depreciation
( 267,404 )
( 178,775 )
Property and equipment, net of accumulated depreciation
$ 595,233
$ 677,485
Depreciation
expense was $ 44,331 and $ 43,315 for the three months ended June 30, 2023, and 2022, respectively. Depreciation expense was $ 88,629 and
$ 70,392 for the six months ended June 30, 2023 and 2022, respectively.
13
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
NOTE
6. ACCRUED LIABILITIES
As
of June 30, 2023 and December 31, 2022, the accrued liabilities of the Company consisted of the following:
SCHEDULE
OF ACCRUED LIABILITIES
June 30, 2023
December 31, 2022
Product development
$ 154,870
$ 195,104
Accrued salaries and wages
518,846
1,175,963
Professional fees
81,955
83,255
Accrued restructuring costs
719,506
—
Accrued franchise taxes
6,299
—
Patent costs
18,000
251,333
Total accrued expenses
$ 1,499,476
$ 1,705,655
NOTE
7. SHARE CAPITAL AND OTHER EQUITY INSTRUMENTS
Authorized
Capital
The
holders of the Company’s common stock are entitled to one vote per share. Holders of common stock are entitled to receive ratably
such dividends, if any, as may be declared by the Board of Directors out of legally available funds. Upon the liquidation, dissolution,
or winding up of the Company, holders of common stock are entitled to share ratably in all assets of the Company that are legally available
for distribution. As of June 30, 2023, 100,000,000 shares of common stock and 20,000,000 shares of Preferred Stock were authorized under
the Company’s articles of incorporation.
Common
Stock Activity
On
February 15, 2022, the Company completed a public offering of 400,000 shares of Common Stock and warrants to purchase up to 400,000 shares
of Common Stock for gross proceeds of approximately $ 10 million, before deducting underwriting discounts and commissions and other offering
expenses. A.G.P./Alliance Global Partners acted as sole book-running manager for the offering. In addition, Enveric granted the underwriter
a 45-day option to purchase up to an additional 60,000 shares of Common Stock and/or warrants to purchase up to an additional 60,000
shares of Common Stock at the public offering price, which the underwriter has partially exercised for warrants to purchase up to 60,000
shares of common stock. At closing, Enveric received net proceeds from the offering of approximately $ 9.1 million, after deducting underwriting
discounts and commissions and estimated offering expenses with $ 5.8 million allocated to equity, $ 3.6 million to warrant liability and
the remaining $ 0.3 million recorded as an expense.
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 116,500 shares of the Company’s common stock, pre-funded warrants to
purchase up to 258,500 shares of common stock (the “RD Pre-Funded Warrants”), and unregistered preferred investment options
(the “RD Preferred Investment Options”) to purchase up to 375,000 shares of common stock (the “RD Offering”).
The gross proceeds from the RD Offering were approximately $ 3,000,000 . Subject to certain ownership limitations, the RD Pre-Funded Warrants
became immediately exercisable at an exercise price equal to $ 0.0001 per share of common stock. On August 3, 2022, all of the issued
RD Pre-Funded Warrants were exercised.
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 116,000 shares of common stock, pre-funded warrants to purchase up to 509,000
shares of common stock (the “PIPE Pre-Funded Warrants”), and preferred investment options (the “PIPE Preferred Investment
Options”) to purchase up to 625,000 shares of the common stock in a private placement (the “PIPE Offering”). The gross
proceeds from the PIPE Offering were approximately $ 5,000,000 . Subject to certain ownership limitations, the PIPE Pre-Funded Warrants
became immediately exercisable at an exercise price equal to $ 0.0001 per share of common stock. All of the issued PIPE Pre-Funded Warrants
were exercised on various dates prior to August 18, 2022.
The
RD Offering and PIPE Offering closed on July 26, 2022, with aggregate gross proceeds of approximately $ 8 million. The aggregate net proceeds
from the offerings, after deducting the placement agent fees and other estimated offering expenses, were approximately $ 7.1 million,
with $ 3.2 million allocated to equity, $ 4.3 million to investment option liability, and the remaining $ 0.4 million recorded as an expense.
14
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
During
the six months ended June 30, 2023, a total of 63,511 shares of Common Stock were issued pursuant to the conversion of restricted stock
units. During the six months ended June 30, 2022, a total of 2,122 shares of Common Stock were issued pursuant to the conversion of restricted
stock units.
Stock
Options
Amendment
to 2020 Long-Term Incentive Plan
On
May 3, 2022, our board of directors (“Board”) adopted the First Amendment (the “Plan Amendment”) to the Enveric
Biosciences, Inc. 2020 Long-Term Incentive Plan (the “Incentive Plan”) to (i) increase the aggregate number of shares available
for the grant of awards by 146,083 shares to a total of 200,000 shares, and (ii) add an “evergreen” provision whereby the
number of shares authorized for issuance pursuant to awards under the Incentive Plan will be automatically increased on the first trading
date immediately following the date the Company issues any share of Common Stock (defined below) to any person or entity, to the extent
necessary so that the number of shares of the Company’s Common Stock authorized for issuance under the Incentive Plan will equal
the greater of (x) 200,000 shares, and (y) 15% of the total number of shares of the Company’s Common Stock outstanding as of such
issuance date. The Plan Amendment was approved by the Company’s shareholders at a special meeting of the Company’s shareholders
held on July 14, 2022.
A
summary of activity under the Company’s incentive plan for the six months ended June 30, 2023, is presented below:
SCHEDULE OF STOCK OPTION
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, 2022
48,329
$ 37.05
$ 44.82
4.1
$ —
Forfeited
( 11,750 )
$ 3.07
$ 2.58
—
$ —
Outstanding at June 30, 2023
36,579
$ 47.93
$ 64.47
3.6
$ —
Exercisable at June 30, 2023
28,265
$ 56.59
$ 76.86
3.2
$ —
The
Company’s stock-based compensation expense, recorded within general and administrative expense in the condensed consolidated statement
of operations and comprehensive loss, related to stock options for the three months ended June 30, 2023, and 2022 was $ 54,375 and $ 48,697 ,
respectively. The Company’s stock-based compensation expense, recorded within general and administrative expense, related to stock
options for the six months ended June 30, 2023 and 2022 was $ 102,461 and $ 85,686 , respectively. As of June 30, 2023, the Company had
$ 138,388 in unamortized stock option expense, which will be recognized over a weighted average period of 1.5 years.
Restricted
Stock Awards
For
the three months ended June 30, 2023, and 2022, the Company recorded $ 0 and $ 6,250 , respectively, in stock-based compensation expense
within general and administrative expense, related to restricted stock awards. For the six months ended June 30, 2023 and 2022, the Company
recorded $ 0 and $ 18,113 , respectively, in stock-based compensation expense within general and administrative expense, related to restricted
stock awards. As of June 30, 2023, there were no unamortized stock-based compensation costs related to restricted share awards. There
are 708 vested and unissued shares of restricted stock awards as of June 30, 2023.
15
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Issuance
of Restricted Stock Units
The
Company’s activity in restricted stock units was as follows for the six months ended June 30, 2023:
SCHEDULE OF RESTRICTED STOCK UNITS AND AWARDS ACTIVITY
Number of shares
Weighted average fair value
Non-vested at December 31, 2022
64,053
$ 92.57
Granted
182,500
$ 2.73
Vested
( 57,280 )
$ 8.93
Forfeited
( 9,158 )
$ 44.69
Non-vested at June 30, 2023
180,115
$ 30.57
For
the three months ended June 30, 2023, and 2022, the Company recorded $ 825,363 and $ 622,596 , respectively, in stock-based compensation
expense related to restricted stock units. For the six months ended June 30, 2023 and 2022, the Company recorded $ 1,310,112 and $ 1,342,363
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 condensed consolidated statement of operations and comprehensive loss. As of June 30, 2023,
the Company had unamortized stock-based compensation costs related to restricted stock units of $ 2,157,127 which will be recognized over
a weighted average period of 2.5 years and unamortized stock-based costs related to restricted stock units which will be recognized upon
achievement of specified milestones. As of June 30, 2023, 55,622 restricted stock units are vested without shares of common stock being
issued, with 38,382 of these shares due as of June 30, 2023.
The
following table summarizes the Company’s recognition of stock-based compensation for restricted stock units for the following periods:
SCHEDULE OF STOCK-BASED COMPENSATION FOR RESTRICTED STOCK UNITS
2023
2022
2023
2022
Three months ended June 30,
Six months ended June 30,
2023
2022
2023
2022
Stock-based compensation expense for RSUs:
General and administrative
$ 592,929
$ 358,818
$ 845,244
$ 717,636
Research and development
232,434
263,778
464,868
624,727
Total
$ 825,363
$ 622,596
$ 1,310,112
$ 1,342,363
Warrants
The
following table summarizes information about shares issuable under warrants outstanding on June 30, 2023:
SCHEDULE
OF WARRANTS OUTSTANDING
Warrant shares outstanding
Weighted average exercise price
Weighted average remaining life
Intrinsic value
Outstanding at December 31, 2022
655,463
$ 58.36
3.6
$ 5,514
Outstanding at June 30, 2023
655,463
$ 58.36
3.1
$ —
Exercisable at June 30, 2023
655,463
$ 58.36
3.1
$ —
The
warrants assumed pursuant to the acquisition of MagicMed contain certain down round features, which were not triggered by the February
2022 public offering and July 2022 RD Offering, that would require adjustment to the exercise price upon certain events when the offering
price is less than the stated exercise price.
Preferred
Investment Options
The
following table summarizes information about investment options outstanding on June 30, 2023:
16
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
SCHEDULE
OF WARRANTS AND INVESTMENT OPTIONS
Investment options outstanding
Weighted average exercise price
Weighted average remaining life
Intrinsic value
Outstanding at December 31, 2022
1,070,000
$ 7.93
5.1
$ —
Outstanding at June 30, 2023
1,070,000
$ 7.93
4.6
$ —
Exercisable at June 30, 2023
1,070,000
$ 7.93
4.6
$ —
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 a Securities Purchase Agreement (the
“Akos Purchase Agreement”) with an accredited investor (the “Akos Investor”), pursuant to which Akos agreed
to sell up to an aggregate of 5,000
shares of Akos Series A Preferred Stock, at price of $ 1,000
per share, and warrants (the “Akos Warrants”) Akos Warrants to purchase shares of Akos’ common stock, par
value $ 0.01
per share (the “Akos Common Stock”), for an aggregate purchase price of up to $ 5,000,000
(the “Akos Private Placement”). The Akos Purchase Agreement is guaranteed by the Company. Pursuant to the Akos Purchase
Agreement, Akos has issued 1,000
shares of the Akos Series A Preferred Stock to the Akos Investor in exchange for $ 1,000,000
on May 5, 2022. The additional $ 4,000,000
will be received on or immediately prior to the Spin-Off. The issuance of the Akos Series A Preferred Stock results in RNCI (see
Note 2). Palladium Capital Advisors, LLC (“Palladium”) acted as placement agent for the Akos Private Placement. Pursuant
to the Akos Purchase Agreement, Akos has agreed to pay Palladium a fee equal to 9% of the aggregate gross proceeds raised from the
sale of the shares of the Akos Series A Preferred Stock and a non-accountable expense allowance of 1% of the aggregate gross
proceeds raised the sale of the Akos Series A Preferred Stock in the Akos Private Placement. The fee due in connection with the Akos
Private Placement to be paid to Palladium in the form of convertible preferred stock and warrants was on similar terms to the
securities issued in the Akos Private Placement. Palladium was also entitled to warrants to purchase Akos Common Stock in an
amount up to 8 %
of the number of shares of Akos Common Stock underlying the shares issuable upon conversion of the Akos Series A Preferred Stock. As
of June 30, 2023, no accruals have been recorded for the fees or warrants since the Akos Series A Preferred Stock has been
redeemed.
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 25 % of the then issued and outstanding Akos Common Stock, subject to
the Beneficial Ownership Limitation (as defined in the Akos Purchase Agreement). Cumulative dividends on each share of Akos Series A
Preferred Stock accrue at the rate of 5 % annually.
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 $ 1,000 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.
17
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
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.
Redemption
of Akos Series A Preferred Stock
In
May 2023, pursuant to the Akos Series A Preferred Certificate of Designations, the holders of the Akos Series A Preferred Stock exercised
the Put Right requiring Akos to force redemption of all of the Akos Series A Preferred Stock for $ 1,000 per
share, plus accrued but unpaid dividends of approximately $ 50,000 for
a total of approximately $ 1,052,057 .
The Company has 20 days following the receipt of the Put Exercise Notice to make the payment and made payment on May 19, 2023. Upon redemption,
the Company revalued the derivative liability and the Company recognized a change in fair value of the derivative liability on the Company’s
Condensed Consolidated Statement of Operations for the three months ended June 30, 2023 of $ 714,000 .
The
Company, Akos, and the Akos Investor have terminated the Akos Purchase Agreement in connection with the planned Spin-Off and certain
registration rights agreement in connection with the Akos Private Placement.
Accounting
for Akos Series A Preferred Stock
Since
the shares of Akos Series A Preferred Stock were 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 were accounted for as a redeemable non-controlling interest and classified
within mezzanine equity in the Company’s condensed consolidated balance sheets. The redeemable non-controlling interest was initially
measured at fair value. Dividends on the shares of Akos Series A Preferred Stock were recognized as preferred dividends attributable
to redeemable non-controlling interest in the Company’s condensed consolidated statement of operations and comprehensive loss.
The
table below presents the reconciliation of changes in redeemable non-controlling interest:
SCHEDULE OF RECONCILIATION CHANGE IN REDEEMABLE NONCONTROLLING INTEREST
Balance at December 31, 2022
$ 885,028
Preferred dividends attributable to redeemable non-controlling interest
19,041
Accretion of embedded derivative and transaction costs associated with Akos Series A Preferred
147,988
Redemption of Akos Series A Preferred Stock
( 1,052,057 )
Balance at June 30, 2023
$ —
As
of June 30, 2023, the Akos Series A Preferred Stock has been redeemed for a total of approximately $ 1,052,057 , and the balance of the
redeemable non-controlling interest is $ 0 .
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.
Australian
Subsidiary Research and Development
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. 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 3,000,000 AUD, which translates to approximately $ 2,000,000 USD as of June 30,
2023. As of June 30, 2023, the Company has paid approximately $ 1,125,103 of the Avance Clinical contract costs and has $ 783,819 recorded
as prepaid assets within prepaid and other current assets on the accompanying condensed consolidated balance sheet. For the three and
six months ended June 30, 2023, the Company has expensed $ 354,419 and $ 355,232 in research and development expenses, respectively, within
the accompanying condensed consolidated statement of operations.
18
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
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.
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 $ 200,000 upon the issuance of a utility patent in the United States or by the European Patent Office, as defined in the agreement.
The Company has accrued such amount as of December 31, 2021, as a result of the milestone criteria being achieved. Payment was made during
January 2022. In addition, a milestone payment totaling $ 300,000 is due upon initiation of a Phase II(b) study. Research activities related
to the relevant patents are still in pre-clinical stage, and accordingly, this milestone has not been achieved. The Vogel-Nathan Purchase
Agreement contains a commitment for payment of royalties equaling 2 % of the first $ 20 million in net sales derived from the commercialization
of products utilizing the relevant patent. As these products are still in the preclinical phase of development, no royalties have been
earned.
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 18 months. These agreements, in aggregate, commit the Company to approximately $ 1.6 million in future
cash payments.
19
Item
2. Management’s discussion and analysis of financial condition and results of operations
The
information set forth below should be read in conjunction with the unaudited condensed consolidated financial statements and notes thereto
included elsewhere in this Quarterly Report on Form 10-Q. Unless stated otherwise, references in this Quarterly Report on Form 10-Q to
“us,” “we,” “our,” or our “Company” and similar terms refer to Enveric Biosciences, Inc.,
a Delaware corporation.
Cautionary
Note Regarding Forward-Looking Statements
This
quarterly report on Form 10-Q (this “Form 10-Q”) contains forward-looking statements within the meaning of the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of forward-looking
terms such as “anticipates,” “assumes,” “believes,” “can,” “could,” “estimates,”
“expects,” “forecasts,” “guides,” “intends,” “is confident that,” “may,”
“plans,” “seeks,” “projects,” “targets,” and “would” or the negative of such
terms or other variations on such terms or comparable terminology. Such forward-looking statements include, but are not limited to, future
financial and operating results, the company’s plans, objectives, expectations and intentions and other statements that are not
historical facts. We have based these forward-looking statements largely on our current expectations and projections about future events
and financial trends that we believe may affect our business, financial condition, and results of operations. These forward-looking statements
speak only as of the date of this Form 10-Q and are subject to a number of risks, uncertainties, and assumptions that could cause actual
results to differ materially from our historical experience and our present expectations, or projections described under the sections
in this Form 10-Q entitled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and
Results of Operations.” These risks and uncertainties include, but are not limited to:
●
our
dependence on the success of our prospective product candidates, which are in the early stages of development and may not reach a
particular stage in development, receive regulatory approval, or be successfully commercialized;
●
potential
difficulties that may delay, suspend, or scale back our efforts to advance additional early research programs through preclinical
development and investigational new drug (“IND”) application filings and into clinical development;
●
the
risk that the cost savings, synergies and growth from our combination with MagicMed Industries Inc. and the successful use of the
rights and technologies acquired in the combination may not be fully realized or may take longer to realize than expected;
●
the
ongoing impact of the novel coronavirus (COVID-19) on our business, including our current plans for product development, as well
as any currently ongoing preclinical studies and clinical trials and any future studies or other development or commercialization
activities;
●
the
limited study on the effects of medical cannabinoids and psychedelics, and the chance that future clinical research studies may lead
to conclusions that dispute or conflict with our understanding and belief regarding the medical benefits, viability, safety, efficacy,
dosing, and social acceptance of cannabinoids or psychedelics;
●
the
expensive, time-consuming, and uncertain nature of clinical trials, which are susceptible to change, delays, termination, and differing
interpretations;
●
the
ability to establish that potential products are efficacious or safe in preclinical or clinical trials;
●
the
fact that our current and future preclinical and clinical studies may be conducted outside the United States, and the United States
Food and Drug Administration may not accept data from such studies to support any new drug applications we may submit after completing
the applicable developmental and regulatory prerequisites;
●
our
ability to effectively and efficiently build, maintain and legally protect our molecular derivatives library so that it can be an
essential building block from which those in the biotech industry can develop new patented products;
●
our
ability to establish or maintain collaborations on the development of therapeutic candidates;
●
our
ability to obtain appropriate or necessary governmental approvals to market potential products;
●
our
ability to manufacture product candidates on a commercial scale or in collaborations with third parties;
●
our
significant and increasing liquidity needs and potential requirements for additional funding;
●
our
ability to obtain future funding for developing products and working capital and to obtain such funding on commercially reasonable
terms;
●
legislative
changes related to and affecting the healthcare system, including, without limitation, changes and proposed changes to the Patient
Protection and Affordable Care Act;
●
the
intense competition we face, often from companies with greater resources and experience than us;
●
our
ability to retain key executives and scientists;
●
the
ability to secure and enforce legal rights related to our products, including intellectual property rights and patent protection;
●
political,
economic, and military instability in Israel which may impede our development programs;
●
our
ability to successfully spin off our cannabinoid assets;
●
our
success at managing the risks involved in the foregoing; and
●
the
risk of loss in excess of insurance limitations on funds help in U.S Banking Institutions.
20
For
a more detailed discussion of these and other factors that may affect our business and that could cause the actual results to differ
materially from those projected in these forward-looking statements, see the risk factors and uncertainties set forth in Part II, Item
1A of this Form 10-Q and Part I, Item 1A of the Annual Report. Any one or more of these uncertainties, risks and other influences could
materially affect our results of operations and whether forward-looking statements made by us ultimately prove to be accurate. We undertake
no obligation to publicly update or revise any forward-looking statements, whether from new information, future events or otherwise,
except as required by law.
Business
Overview
We
are a biotechnology company dedicated to the development of novel small-molecule therapeutics for the treatment of anxiety, depression,
and addiction disorders. We seek to improve the lives of patients suffering from cancer, initially by developing palliative and supportive
care products for people suffering from certain side effects of cancer and cancer treatment such as pain or skin irritation. We currently
intend to offer such palliative and supportive care products in the United States, following approval through established regulatory
pathways.
Psychedelics
Following
our amalgamation with MagicMed completed in September 2021 (the “Amalgamation”), we have continued to pursue the development
of MagicMed’s proprietary Psychedelic Derivatives library, the Psybrary™ which we believe will help us to identify and develop
the right drug candidates needed to address mental health challenges, including cancer-related distress. We synthesize novel versions
of classic psychedelics, such as psilocybin, N-dimethyltryptamine (DMT), mescaline and MDMA, using a mixture of chemistry and synthetic
biology, resulting in the expansion of the Psybrary™, which includes 15 patent families with over a million potential variations
and hundreds of synthesized molecules. Within the Psybrary™ we have three different types of molecules, Generation 1 (classic psychedelics),
Generation 2 (pro-drugs), and Generation 3 (new chemical entities). The Company is working to add novel psychedelic molecular compounds
and Psychedelic Derivatives on a regular basis through our work at Enveric Labs in Calgary, Alberta, Canada, where we have a team of
PhD scientists with expertise in synthetic biology and chemistry. To date we have created over 500 molecules that are housed in the Psybrary.
We
screen newly synthesized molecules in the Psybrary™ through PsyAI™, a proprietary AI tool. Leveraging AI systems is expected
to reduce the time and cost of pre-clinical, clinical, and commercial development. We believe it streamlines pharmaceutical design by
predicting ideal binding structures of molecules, manufacturing capabilities, and pharmacological effects to help determine ideal drug
candidates, tailored to each indication. Each of these molecules that we believe are patentable can then be further screened to see how
changes to its makeup alter its effects in order to synthesize additional new molecules. New compounds of sufficient purity are undergoing
pharmacological screening, including non-clinical (receptors/cell lines), preclinical (animal), and ultimately clinical (human) evaluations.
We intend to utilize our Psybrary™ and the AI tool to categorize and characterize the Psybrary™ substituents to focus on
bringing more psychedelics-inspired molecules from discovery to the clinical phase.
Cannabinoids
We
aim to advance a pipeline of novel cannabinoid combination therapies for the side effects of cancer treatments, such as chemotherapy
and radiotherapy.
We
intend to bring together leading oncology clinicians, researchers, academic and industry partners to develop both external proprietary
products and a robust internal pipeline of product candidates aimed at improving quality of life and outcomes for cancer patients. We
intend to evaluate options to out-license our proprietary technology as it moves along the regulatory pathway.
21
In
developing our product candidates, we intend to focus on cannabinoids derived from non-hemp botanical sources, and synthetic materials
containing no tetrahydrocannabinol (“THC”) in order to comply with U.S. federal regulations. Of the potential cannabinoids
to be used in therapeutic formulations, THC, which is responsible for the psychoactive properties of marijuana, can result in undesirable
mood effects. Selected cannabidiol (CBD) and cannabigerol (CBG) candidates, on the other hand, have amounts of THC well below 0.1% and
are not psychotropic and therefore more attractive candidates for translation into therapeutic practice. Drugs with less than 0.1% THC
have a history, when approved as drugs by the Food and Drug Administration “FDA”, of being able to be rescheduled by DEA
from Schedule I to Schedule V, as in the case of Epidiolex and Marinol. In the future, we may utilize cannabinoids that are derived from
cannabis plants, which may contain higher amounts of THC; however, we only intend to do so in jurisdictions where THC is legal. However,
synthetic THC is a Schedule I controlled substance; so, the use of any APIs (Active Pharmaceutical Ingredients) containing synthetic
THC (or naturally derived THC in concentrations greater than 0.3%) may increase regulatory scrutiny and require additional expenses and
authorizations. All current and future product candidates that we are developing or may develop will be tested for safety and efficacy
under an IND application and subject to the FDA pre-market approval process for new drugs.
While
we continue to pursue the development of our cannabinoid-based product candidates, our principal focus is on the development of psychedelic-based
treatments.
On
May 11, 2022, the Company announced plans to transfer and spin-off its cannabinoid clinical development pipeline assets (the “Spin-Off”)
to Akos Biosciences, Inc. (formerly known as Acanna Therapeutics, Inc.), a majority owned subsidiary of the Company (“Akos”).
In connection with the Spin-Off, the Company would transfer its cannabinoid clinical development pipeline assets to Akos, while retaining
its psychedelics clinical development pipeline assets. The Spin-Off was 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.
In
May 2023, pursuant to the Akos Series A Preferred Certificate of Designations, the holders of the Akos Series A Preferred Stock exercised
their Put Right requiring Akos to redeem all of the outstanding shares of Akos Series A Preferred Stock for $1,000 per share, plus
accrued but unpaid dividends of approximately $50,000 for a total redemption amount of approximately $1,052,057. The Company completed
the redemption May 19, 2023. The Company now plans to engage with strategic advisors to identify and pursue alternative routes to capture value
from the cannabinoid assets.
Recent
Developments
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. 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
TGA and is currently in preclinical development targeting the treatment of anxiety disorder. The total cost of the Avance Clinical contract
is approximately 3,000,000 AUD, which translates to approximately $2,000,000 as of June 30, 2023. As of June 30, 2023, the Company has
paid approximately $1,125,103 of the Avance Clinical contract costs and has $783,819 recorded as prepaid assets. For the three and six
months ended June 30, 2023, the Company has expensed $354,419 and $355,232 in research and development expenses, respectively.
22
Reduction
in Force/Restructuring
In
May 2023, the Company entered into a cost reduction plan, including a reduction in force of approximately 35% of its full-time
employees to streamline its operations and conserve cash resources. Additionally, contracts with seven consultants that were focused
on the Akos cannabinoid spin-out will be terminated. The Company recognized severance charges of approximately $453,059 through June
30, 2023. The plan included a focus on progressing the Company’s existing non-cannabinoid pipeline while reducing the rate of
spend and managing cash flow. As of June 30, 2023, the Company has completed the reduction in force, with such severance expenses
recorded in salaries and wages and legal accounts.
On June 16, 2023, the Company entered into a separation agreement
with Avani Kanubaddi, the Company’s President and Chief Operating Officer (the “Kanubaddi Separation Agreement”). In
accordance with the Kanubaddi Separation Agreement, Mr. Kanubaddi’s outstanding RSUs will retain their vesting conditions. Mr. Kanubaddi’s
2023 salary and benefits of $464,468 was accrued and will be paid out in twelve equal monthly installments beginning in July 2023. Upon
termination, any unvested time-based RSU’s became fully vested. The Company accelerated expense recognized related to these shares that
vested upon termination of $231,273. Of the 11,278 market performance-based RSUs, 3,759 will continue to be subject to the original terms
and conditions of Mr. Kanubaddi’s employment agreement and the remainder were forfeited.
Results
of Operations
The
following table sets forth information comparing the components of net loss for the three months ended June 30, 2023, and 2022:
For the Three Months Ended June 30,
2023
2022
Operating expenses
General and administrative
$ 3,155,400
$ 2,501,206
Research and development
2,513,089
2,120,051
Depreciation and amortization
86,518
85,502
Total operating expenses
5,755,007
4,706,759
Loss from operations
(5,755,007 )
(4,706,759 )
Other income (expense)
Change in fair value of warrant liabilities
(233,821 )
1,969,922
Change in fair value of investment option liability
(1,082,141 )
—
Change in fair value of derivative liability
714,000
(53,000 )
Interest income (expense)
916
(668 )
Total other (expense) income
(601,046 )
1,916,254
Net loss
$ (6,356,053 )
$ (2,790,505 )
General
and Administrative Expenses
Our
general and administrative expenses increased to $3,155,400 for the three months ended June 30, 2023 from $2,501,206 for the three months
ended June 30, 2022, an increase of $654,194, or 26%. This change was primarily driven by an increase in consulting fees of $396,684,
an increase in salaries and wages of $330,683, and an increase in stock-based compensation associated with accelerated expense on restricted
stock units of $227,861, all primarily related to the reduction in force that occurred during the three months ended June 30, 2023. Other
increases related to an increase in director fees of $68,479. This is slightly offset by a decrease in director and officer insurance
of $264,350 and a decrease in legal expenses of $175,317 for the three months ended June 30, 2023 as compared to the three months ended
June 30, 2022.
Research
and Development Expenses
Our
research and development expense for the three months ended June 30, 2023 was $2,513,089 as compared to $2,120,051 for the three months
ended June 30, 2022 with an increase of $393,038, or approximately 19%. This change was primarily driven by an increase of $355,232 in
costs associated with the Avance Clinical contract during the three months ended June 30, 2023 as compared to the three months ended
June 30, 2022. The Avance Clinical contract was entered into in March 2023, and therefore there was no expense incurred on this contract
during the three months ended June 30, 2022.
23
Depreciation
and Amortization Expense
Depreciation
and amortization expense for the three months ended June 30, 2023 was $86,518 as compared to $85,502 for the three months ended June
30, 2022, with an increase of $1,016, or approximately 1%. Depreciation and amortization expense was substantially similar for the three
months ended June 30, 2023 compared with the three months ended June 30, 2022.
Change
in Fair Value of Warrant Liabilities
Change
in fair value of warrant liabilities for the three months ended June 30, 2023 resulted in expense of $233,821 as compared to income of
$1,969,922 for the three months ended June 30, 2022. The change in fair value of warrant liabilities is significantly influenced by the
change in the closing price of Common Stock at the end of each period, as compared to the closing price of Common Stock at the beginning
of each period with a strong inverse relationship between changes in fair value of warrant liabilities and the trading price of Common
Stock. The Company’s stock price was $3.37 as of June 30, 2023, $1.66 as of March 31, 2023, $10.70 as of June 30, 2022 and $16.50
as of March 31, 2022. The stock price of the Company increased approximately 103% during the three months ended June 30, 2023 compared
to a decrease of approximately 35% during the three months ended June 30, 2022. The significant percentage change in the Company’s
stock price during the three months ended June 30, 2023 compared to the three months ended June 30, 2022, resulted in the increase to
the change in fair value of warrant liabilities.
Change
in Fair Value of Investment Option Liability
Change
in fair value of investment option liability for the three months ended June 30, 2023 resulted in expense of $1,082,141. The Company
did not have any outstanding investment option liabilities during the three months ended June 30, 2022. The change in fair value is due
to the significant increase in the Company’s stock price for the three months ended June 30, 2023. The Company’s stock price
was $1.66 on March 31, 2023 and $3.37 on June 30, 2023, an increase of approximately 103% during that time.
Change
in Fair Value of Derivative Liability
The
Company’s change in fair value of derivative liability was expense of $53,000 for the three months ended June 30, 2022, compared
with income of $714,000 for the three months ended June 30, 2023 due primarily to redemption of the redeemable stock and the decreased
probability of occurrence of the Akos spin-off as of June 30, 2023 as compared to March 31, 2023.
The
following table sets forth information comparing the components of net loss for the six months ended June 30, 2023 and 2022:
For the Six Months Ended June 30,
2023
2022
Operating expenses
General and administrative
$ 5,910,991
$ 5,269,072
Research and development
4,531,690
4,078,765
Depreciation and amortization
173,004
154,767
Total operating expenses
10,615,685
9,502,604
Loss from operations
(10,615,685 )
(9,502,604 )
Other income (expense)
Change in fair value of warrant liabilities
(183,164 )
2,245,891
Change in fair value of investment option liability
(962,636 )
—
Change in fair value of derivative liability
727,000
(53,000 )
Interest income (expense)
905
(4,806 )
Total other (expense) income
(417,895 )
2,188,085
Net loss
$ (11,033,580 )
$ (7,314,519 )
24
General
and Administrative Expenses
Our
general and administrative expenses increased to $5,910,991 for the six months ended June 30, 2023 from $5,269,072 for the six
months ended June 30, 2022, an increase of $641,919, or 12%. This change was primarily driven by an increase in consulting fees of
$693,420, coupled with an increase in stock-based compensation associated with restricted stock units and RSAs of $109,495, an
increase in salaries and wages of $92,509, and an increase in stock-based compensation associated with options of $16,775, all
primarily due to the restructuring that occurred during the three months ended June 30, 2023. Other increases related to an increase
in Delaware franchise taxes of $261,075 and an increase in accounting fees of $241,359. This is offset by a decrease in director and
officer insurance of $528,700 and a decrease in legal fees of $209,485 during the six months ended June 30, 2023 as compared to the
six months ended June 30, 2022.
Research
and Development Expenses
Our
research and development expense for the six months ended June 30, 2023 was $4,531,690 as compared to $4,078,765 for the six months ended
June 30, 2022 with an increase of $452,925, or approximately 11%. This change was primarily driven by an increase of $355,232 in costs
associated with the Avance Clinical contract during the six months ended June 30, 2023 as compared to the six months ended June 30, 2022.
The Avance Clinical contract was entered into in March 2023, and therefore there was no expense incurred on this contract during the
six months ended June 30, 2022.
Depreciation
and Amortization Expense
Depreciation
and amortization expense for the six months ended June 30, 2023 was $173,004 as compared to $154,767 for the six months ended June 30,
2022, with an increase of $18,237, or approximately 12%. This increase is due to fixed asset additions during the six months ended June
30, 2022 which only incurred partial depreciation, compared to a full six months’ of depreciation during the six months ended June
30, 2023.
Change
in Fair Value of Warrant Liabilities
Change
in fair value of warrant liabilities the six months ended June 30, 2023 resulted in expense of $183,164 as compared to income of $2,245,891
the six months ended June 30, 2022. The change in fair value of warrant liabilities is significantly influenced by the change in the
closing price of Common Stock at the end of each period, as compared to the closing price of Common Stock at the beginning of each period
with a strong inverse relationship between changes in fair value of warrant liabilities and the trading price of Common Stock. The Company’s
stock price was $3.37 as of June 30, 2023, $2.08 as of December 31, 2022, $10.70 as of June 30, 2022 and $46.50 as of December 31, 2021.
The stock price of the Company increased approximately 62% during the six months ended June 30, 2023 compared to a decrease of approximately
77% during the six months ended June 30, 2022. The significant percentage change in the Company’s stock price during the six months
ended June 30, 2023 compared to the six months ended June 30, 2022, resulted in the increase to the change in fair value of warrant liabilities.
Change
in Fair Value of Investment Option Liability
Change
in fair value of investment option liability during the six months ended June 30, 2023 resulted in expense of $962,636. The Company did
not have any outstanding investment option liabilities during the six months ended June 30, 2022. The change in fair value is due to
the significant increase in the Company’s stock price the six months ended June 30, 2023. The Company’s stock price was $2.08
on December 31, 2022 and $3.37 on June 30, 2023, an increase of approximately 62% during that time.
Change
in Fair Value of Derivative Liability
The
Company’s change in fair value of derivative liability was expense of $53,000 for the six months ended June 30, 2022 compared to
income of $727,000 for the six months ended June 30, 2023, due primarily to the decreased probability of occurrence of the Akos spin-off
and Akos Series A Preferred Stock redemption as of June 30, 2023 as compared to December 31, 2022.
Going
Concern, Liquidity and Capital Resources
The
Company has incurred a loss since inception resulting in an accumulated deficit of $90,241,366 as of June 30, 2023 and further losses
are anticipated in the development of its business. Further, the Company has operating cash outflows of $9,602,930 for the year ended
June 30, 2023. For the six months ended June 30, 2023, the Company had a loss from operations of $10,615,685. Since inception, being
a research and development company, the Company has not yet generated revenue and the Company has incurred continuing losses from its
operations. The Company’s operations have been funded principally through the issuance of debt and equity. These factors raise
substantial doubt about the Company’s ability to continue as a going concern for a period of one year from the issuance of these
financial statements.
25
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 June 30, 2023, the Company had cash
of $7,081,408 and working capital of $3,974,419. The Company’s current cash on hand is not sufficient enough to satisfy its operating
cash needs for the 12 months from the filing of this Quarterly Report on Form 10-Q. These conditions raise substantial doubt regarding
the Company’s ability to continue as a going concern for a period of one year after the date the financial statements are issued.
Management’s plan to alleviate the conditions that raise substantial doubt include reducing the Company’s rate of spend,
managing its cash flow, advancing its programs, and raising additional working capital through public or private equity or debt financings
or other sources, which may include collaborations with third parties as well as disciplined cash spending, to increase the Company’s
cash runway. Adequate additional financing may not be available to us on acceptable terms, or at all. Should the Company be unable to
raise sufficient additional capital, the Company may be required to undertake cost-cutting measures including delaying or discontinuing
certain operating activities.
In
May 2023, the Company entered into a cost reduction plan, including a reduction in force of approximately 35% of its full-time
employees to streamline its operations and conserve cash resources. Additionally, contracts with seven consultants that were focused
on the Akos cannabinoid spin-out will be terminated. Additionally, on June 16, 2023, the Company entered into the Kanubaddi
Separation Agreement with Avani Kanubaddi, the Company’s President and Chief Operating Officer. In accordance with the
Kanubaddi Separation Agreement, Mr. Kanubaddi’s outstanding RSUs will retain their vesting conditions. Mr. Kanubaddi’s
2023 salary and benefits was accrued and will be paid out in twelve equal monthly installments beginning in July 2023. The Company
recognized severance charges of approximately $917,527 through June 30, 2023, with $190,808 of these charges paid as of June 30,
2023. The plan included a focus on progressing the Company’s existing non-cannabinoid pipeline while reducing the rate of
spend and managing cash flow. As of June 30, 2023, the Company has completed the reduction in force, with such severance expenses
recorded in salaries and wages and legal accounts.
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 condensed consolidated
financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Cash
Flows
Since
inception, we have primarily used our available cash to fund our product development and operations expenditures.
Cash
Flows for the Six Months Ended June 30, 2023 and 2022
The
following table sets forth a summary of cash flows for the years presented:
For the Six Months Ended June 30,
2023
2022
Net cash used in operating activities
$ (9,602,930 )
$ (9,134,138 )
Net cash used in investing activities
11,685
(559,398 )
Net cash (used in) provided by financing activities
(1,052,057 )
10,355,922
Effect of foreign exchange rate on cash
826
(9,434 )
Net (decrease) increase in cash
$ (10,642,476 )
$ 652,952
Operating
Activities
Net
cash used in operating activities was $9,602,930 during the six months ended June 30, 2023, which consisted primarily of a net loss adjusted
for non-cash items of $8,978,712, an increase in prepaid expenses of $1,111,913, and a decrease in accounts payable and accrued liabilities
of $542,397.
Net
cash used in operating activities was $9,134,138 during the six months ended June 30, 2022, which consisted primarily of a net loss adjusted
for non-cash items of $7,837,571, increase in prepaid expenses and other current assets of $1,031,979, and a decrease in accounts payable
and accrued liabilities of $187,902.
26
Investing
Activities
Net
cash used in investing activities was $11,685 during the six months ended June 30, 2023, which consisted of the purchase of property and
equipment.
Net
cash used in investing activities was $559,398 during the six months ended June 30, 2022, which consisted of the purchase of property
and equipment.
Financing
Activities
Net
cash used in financing activities was $1,052,057 during the six months ended June 30, 2023, which consisted of the redemption of redeemable
non-controlling interest.
Net
cash provided by financing activities was $10,355,922 during the six months ended June 30, 2022, which consisted of $9,397,884 in proceeds
from the sale of common stock and warrants and $958,038 in proceeds from the sale of redeemable non-controlling interest.
Critical
Accounting Policies and Significant Judgments and Estimates
The
Company’s accounting policies are fundamental to understanding its management’s discussion and analysis. The Company’s
significant accounting policies are presented in Note 2 to its financial statements for the year ended December 31, 2022, and included
in the Annual Report. The Company’s financial statements have been prepared in accordance with accounting principles generally
accepted in the United States of America (“U.S. GAAP”) for interim financial information. Accordingly, they do not include
all of the information and notes required by U.S. GAAP. However, in the opinion of the management of the Company, all adjustments necessary
for a fair presentation of the financial position and operating results have been included in the Company’s unaudited condensed
consolidated financial statements.
27
Item
3. Quantitative and Qualitative Disclosures About Market Risk
From
inception through June 30, 2023, the Company’s reporting currency is the United States dollar while the functional currency of
certain of the Company’s subsidiaries were the Canadian dollar and Australian dollar. For the reporting periods ended June 30,
2023 and June 30, 2022, the Company engaged in a number of transactions denominated in Canadian dollars and Australian dollars. As a
result, the Company is subject to exposure from changes in the exchange rates of the Canadian dollar and Australian dollar against the
U.S. dollar.
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.
Item
4. Controls and Procedures
Evaluation
of Disclosure Controls and Procedures
We
maintain disclosure controls and procedures designed to ensure that the information we are required to disclose in reports we file or
submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified under the rules and
forms of the SEC. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that such
information is accumulated and communicated to our management, including our Chief Executive Officer and our Chief Financial Officer,
as appropriate, to allow timely decisions regarding required disclosures. A material weakness is a deficiency, or combination of deficiencies,
in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our annual
or interim financial statements will not be prevented or detected on a timely basis. The matters that management identified in our Annual
Report for the year ended December 31, 2022, continued to exist and were still considered material weaknesses in our internal control
over financial reporting at June 30, 2023.
As
required by paragraph (b) of Rules 13a-15 and 15d-15 under the Exchange Act, our Chief Executive Officer (our principal executive) and
Chief Financial Officer (our principal financial officer and principal accounting officer) carried out an evaluation of the effectiveness
of the design and operation of our disclosure controls and procedures as of June 30, 2023. Based on this evaluation, and in light of
the material weaknesses found in our internal controls over financial reporting, our Chief Executive Officer and Chief Financial Officer
concluded that our disclosure controls and procedures (as defined in paragraph (e) of Rules 13a-15 and 15d-15 under the Exchange Act)
were not effective as of June 30, 2023.
Management’s
Remediation Plan
As
previously discussed in our Annual Report for the year ended December 31, 2022, management had concluded that our internal control over
financial reporting was not effective as of December 31, 2022, because management identified inadequate segregation of duties to ensure
the processing, review, and authorization of all transactions, including non-routine transactions resulting in deficiencies, which, in
aggregate, amounted to a material weakness in the Company’s internal control over financial reporting.
As
of June 30, 2023, there were control deficiencies that constituted a material weakness in our internal control over financial reporting.
Management has taken, and is taking steps to strengthen our internal control over financial reporting: we have conducted evaluation of
the material weakness to determine the appropriate remedy and have established procedures for documenting disclosures and disclosure
controls.
While
we have taken certain actions to address the material weaknesses identified, additional measures may be necessary as we work to improve
the overall effectiveness of our internal controls over financial reporting.
Changes
in Internal Control over Financial Reporting
Other
than the changes discussed above in the Remediation Plan, there have been no other changes in our internal controls over financial reporting
(as defined in Rule 13a-15(f) and 15d-(f) of the Exchange Act) that occurred during quarter ending June 30, 2023, that have materially
affected, or are reasonably likely to materially affect, our internal control over financial reporting.
28
PART
II. OTHER INFORMATION
Item
1. Legal Proceedings
The
Company is periodically involved in legal proceedings, legal actions and claims arising in the ordinary course of business. Other than
as described below, we do not have any pending litigation that, separately or in the aggregate, would, in the opinion of management,
have a material adverse effect on our financial position, results of operations or cash flows.
Item
1A. Risk Factors
Factors
that could cause our actual results to differ materially from those in this Quarterly Report are any of the risks described below and
in the Annual Report. Any of these factors could result in a significant or material adverse effect on our results of operations of financial
condition. Additional risk factors not presently known to us or that we currently deem immaterial may also impair our business or results
of operations.
The
following discussion of risk factors contains forward-looking statements. These risk factors may be important to understanding other
statements in this Form 10-Q. The following information should be read in conjunction with the condensed consolidated financial statements
and related notes in Part I, Item 1, “Financial Statements” and Part I, Item 2, “Management’s Discussion and
Analysis of Financial Condition and Results of Operations” of this Form 10-Q.
We
may not realize the benefits we expect from our cost reduction plan or, as a result of the reduction in force, we may not be successful
in attracting, motivating and retaining highly qualified personnel in the future.
In
May 2023, the Company entered into a cost reduction plan, including a reduction in force of approximately 35% of its full-time employees.
Additionally, contracts with seven consultants that were focused on the Akos cannabinoid spin-out will be terminated. In addition, the
Company entered into a separation agreement with Avani Kanubaddi, the Company’s President and Chief Operating Officer. The Company
recorded a charge of approximately $918,000 in severance and benefits. The Company may not realize, in full or in part, the anticipated
benefits and savings from its cost reduction plan, and it cannot guarantee that it will not have to undertake additional reductions in
force or restructuring activities in the future. Furthermore, the cost reduction plan may be disruptive to the Company’s operations.
For example, the cost reduction plan could yield unanticipated consequences, such as attrition beyond planned staff reductions, increased
difficulties in the Company’s day-to-day operations and reduced employee morale.
The
reduction in force could also harm the Company’s ability to attract, motivate and retain qualified personnel who are critical to
its business in the future. Recruiting and retaining qualified employees, consultants and advisors for the Company’s business is
and will continue to be critical to its success. Competition for skilled personnel is intense and the turnover rate can be high. Any
failure to attract or retain qualified personnel could prevent the Company from successfully developing the Company’s product candidates
in the future.
Our
reprioritization and the associated headcount reduction may not result in anticipated savings, could result in total costs and expenses
that are greater than expected and could disrupt our business.
The
Company may incur additional expenses not currently contemplated due to events associated with the reduction in force entered into by
the Company in May 2023, for example, the reduction in force may have a future impact on other areas of the Company’s liabilities
and obligations. The Company may not realize, in full or in part, the anticipated benefits and savings from the reduction in force due
to unforeseen difficulties, delays or unexpected costs. If the Company is unable to realize the expected operational efficiencies and
cost savings from the reduction in force, the Company’s operating results and financial condition would be adversely affected.
In addition, the Company may need to undertake restructuring activities or workforce reductions in the future. Furthermore, the Company’s
initiatives to re-balance its cost structure, including the reduction in force, may be disruptive to the Company’s operations.
If employees who were not affected by the reduction in force seek alternative employment, this could result in the Company seeking contractor
support at unplanned additional expense or harm its productivity. Any disruption in the Company’s business as a result of the reduction
in force could prevent the Company from successfully developing the Company’s product candidates in the future.
Item
2. Unregistered Sales of Equity Securities and Use of Proceeds
None.
Item
3. Defaults Upon Senior Securities
None.
Item
4. Mine Safety Disclosures
Not
applicable.
Item
5. Other Information
In
May 2023, pursuant to the Akos Series A Preferred Certificate of Designations, the holders of the Akos Series A Preferred Stock exercised
the Put Right requiring Akos to force redemption of all of the Akos Series A Preferred Stock for $1,000 per share, plus accrued
but unpaid dividends of approximately $50,000 for a total of approximately $1,052,057. The Company has 20 days following the receipt
of the Put Exercise Notice to make the payment and made payment on May 19, 2023.
The
Company, Akos, and the Akos Investor intend to terminate the Akos Purchase Agreement in connection with the planned Spin-Off and that
certain registration rights agreement in connection with the Akos Private Placement.
In
May 2023, the Company entered into a cost reduction plan, including a reduction in force of approximately 35% of its full-time
employees to streamline its operations and conserve cash resources. Additionally, contracts with seven consultants that were focused
on the Akos cannabinoid spin-out will be terminated. The Company recognized severance charges of approximately $917,527 through June
30, 2023. The plan included a focus on progressing the Company’s existing non-cannabinoid pipeline while reducing the rate of
spend and managing cash flow. As of June 30, 2023, the Company has completed the reduction in force, with such severance expenses
recorded in salaries and wages and legal accounts.
Item
6. Exhibits
INDEX
TO EXHIBITS
Exhibit No.
Description
31.1*
Certification pursuant to Section 302 of the Sarbanes–Oxley Act of 2002 of Principal Executive Officer*
31.2*
Certification pursuant to Section 302 of the Sarbanes–Oxley Act of 2002 of Principal Financial and Accounting Officer*
32.1**
Certification pursuant to Section 906 of the Sarbanes–Oxley Act of 2002 of Principal Executive Officer, Principal Financial and Accounting Officer**
101.INS*
Inline XBRL Instance Document*
101.SCH*
Inline XBRL Taxonomy Extension Schema*
101.CAL*
Inline XBRL Taxonomy Extension Calculation Linkbase Document*
101.DEF*
Inline XBRL Taxonomy Extension Definition Linkbase Document*
101.LAB*
Inline XBRL Taxonomy Extension Labels Linkbase Document*
101.PRE*
Inline XBRL Taxonomy Extension Presentation Linkbase Document*
104*
Cover Page Interactive Data File (formatted as Inline XBRL document
and contained in Exhibit 101)
*
Filed herewith.
**
Furnished herewith.
29
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned, thereunto duly authorized.
ENVERIC BIOSCIENCES, INC
August
11, 2023
By:
/s/
Dr. Joseph Tucker
Dr.
Joseph Tucker
Chief
Executive Officer
(Principal
Executive Officer)
August
11, 2023
By:
/s/
Kevin Coveney
Kevin
Coveney
Chief
Financial Officer
(Principal
Financial and Accounting Officer)
30
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.