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: September 30, 2022
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 November 11, 2022, there were 2,078,271 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 September 30, 2022 (Unaudited) and December 31, 2021
2
Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss for the three and nine months ended September 30, 2022 and 2021
3
Unaudited Condensed Consolidated Statements of Changes in Stockholders’ Equity for the three and nine months ended September 30, 2022 and 2021
4-5
Unaudited Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2022 and 2021
6
Notes to Unaudited Condensed Consolidated Financial Statements
7
Item
2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
23
Item
3.
Quantitative and Qualitative Disclosures About Market Risk
33
Item
4.
Controls and Procedures
34
PART II - OTHER INFORMATION
Item
1.
Legal Proceedings
35
Item
1A.
Risk Factors
35
Item
2.
Unregistered Sales of Equity Securities and Use of Proceeds
36
Item
3.
Defaults Upon Senior Securities
36
Item
4.
Mine Safety Disclosures
36
Item
5.
Other Information
36
Item
6.
Exhibits
37
Signatures
39
1
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED BALANCE SHEETS
September
30, 2022
December
31, 2021
(unaudited)
ASSETS
Current
assets:
Cash
$ 21,201,005
$ 17,355,999
Prepaid
expenses and other current assets
1,065,795
380,838
Total
current assets
22,266,800
17,736,837
Other assets:
Property and equipment,
net
712,944
294,430
Right-of-use operating
lease asset
88,768
176,304
Intangible assets, net
6,318,509
6,923,928
Goodwill
1,468,389
1,587,634
Total
other assets
8,588,610
8,982,296
Total
assets
$ 30,855,410
$ 26,719,133
LIABILITIES AND SHAREHOLDERS’
EQUITY
Current
liabilities:
Accounts payable
$ 710,314
$ 683,393
Accrued liabilities
1,113,145
1,292,721
Current portion of right-of-use
operating lease obligation
88,769
107,442
Derivative
liability
686,000
—
Total
current liabilities
2,598,228
2,083,556
Non-current liabilities:
Non-current portion of
right-of-use operating lease obligation
—
68,861
Deferred tax liability
1,486,413
1,607,122
Investment option liability
2,514,112
—
Warrant
liability
654,937
653,674
Total
non-current liabilities
4,655,462
2,329,657
Total
liabilities
$ 7,253,690
$ 4,413,213
Commitments and contingencies
(Note 7)
-
-
Mezzanine equity
Redeemable
non-controlling interest
761,434
—
Total
mezzanine equity
761,434
—
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
September 30, 2022 and December 31, 2021
—
—
Common stock, $ 0.01 par value, 100,000,000
shares authorized, 2,078,271 and 651,921 shares issued and outstanding as of September 30, 2022 and December 31, 2021, respectively
20,782
6,519
Additional paid-in capital
93,989,885
83,066,656
Accumulated deficit
( 70,529,884 )
( 60,736,453 )
Accumulated
other comprehensive loss
( 640,497 )
( 30,802 )
Total
shareholders’ equity
22,840,286
22,305,920
Total
liabilities, mezzanine equity, and shareholders’ equity
$ 30,855,410
$ 26,719,133
See
the accompanying notes to the unaudited condensed consolidated financial statements.
2
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
UNAUDITED
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
2022
2021
2022
2021
For
the Three Months Ended
September 30,
For
the Nine Months Ended
September 30,
2022
2021
2022
2021
Operating expenses
General and
administrative
$ 3,514,547
$ 2,123,834
$ 8,783,619
$ 10,864,696
Research and development
2,055,656
1,219,339
6,134,421
2,295,826
Depreciation
and amortization
86,646
173,696
241,413
484,355
Total
operating expenses
5,656,849
3,516,869
15,159,453
13,644,877
Loss from operations
( 5,656,849 )
( 3,516,869 )
( 15,159,453 )
( 13,644,877 )
Other income (expense)
Inducement expense
—
—
—
( 298,714 )
Change in fair value of
warrant liabilities
1,599,623
804,833
3,845,514
7,077,376
Change in fair value of
investment option liability
1,809,622
—
1,809,622
—
Change in fair value of
derivative liability
( 231,000 )
—
( 284,000 )
—
Interest
expense
( 308 )
( 370 )
( 5,114 )
( 5,191 )
Total
other income
3,177,937
804,463
5,366,022
6,773,471
Net loss
$ ( 2,478,912 )
$ ( 2,712,406 )
$ ( 9,793,431 )
$ ( 6,871,406 )
Less preferred dividends
attributable to non-controlling interest
12,603
—
20,411
—
Less
deemed dividends attributable to accretion of embedded derivative at redemption value
110,991
—
184,985
—
Net loss attributable to
shareholders
( 2,602,506 )
( 2,712,406 )
( 9,998,827 )
( 6,871,406 )
Other comprehensive loss
Foreign currency translation
( 417,390 )
( 6,510 )
( 609,695 )
( 4,036 )
Comprehensive
loss
$ ( 3,019,896 )
$ ( 2,718,916 )
$ ( 10,608,522 )
$ ( 6,875,442 )
Net loss per share -
basic and diluted
$ ( 1.46 )
$ ( 5.91 )
$ ( 8.11 )
$ ( 16.64 )
Weighted average shares outstanding, basic
and diluted
1,787,235
459,289
1,232,936
413,063
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 (DEFICIT) FOR THE THREE AND NINE MONTHS ENDED
SEPTEMBER 30, 2022 AND 2021
Shares
Amount
Shares
Amount
Capital
Deficit
Income (Loss)
Total
Series
B Preferred Stock
Common
Stock
Additional Paid-In
Accumulated
Accumulated Other Comprehensive
Shares
Amount
Shares
Amount
Capital
Deficit
Income (Loss)
Total
Balance at January 1, 2021
-
-
-
3,275,407
$ 32,754
202,249
$ 2,022
$ 15,321,699
$ ( 11,759,557 )
$ ( 181,277 )
$ 3,415,641
January 2021 registered
direct offering, net of offering costs
—
—
44,427
444
4,616,643
—
—
4,617,087
February 2021 registered
direct offering, net of offering costs
—
—
60,141
601
7,015,800
—
—
7,016,401
Stock-based compensation
—
—
—
—
3,591,565
—
—
3,591,565
Induced conversion of stock
options into restricted stock awards
—
—
—
—
298,714
—
—
298,714
Conversion of Series B
Preferred Stock
( 3,275,407 )
( 32,754 )
65,509
655
32,099
—
—
—
Exercise of warrants
—
—
17,022
170
3,267,075
—
—
3,267,245
Foreign exchange translation
gain
—
—
—
—
—
—
35,736
35,736
Net
loss
-
-
-
—
—
—
—
—
( 3,250,711 )
—
( 3,250,711 )
Balance at March 31,
2021
-
-
-
—
$ —
389,348
$ 3,892
$ 34,143,595
$ ( 15,010,268 )
$ ( 145,541 )
$ 18,991,678
Stock-based compensation
—
—
283
3
750,930
—
—
750,933
Conversion of stock options
into restricted stock
—
—
843
8
( 8 )
—
—
—
Exercise of warrants
—
—
35,839
358
17,570
—
—
17,928
Exercise of options
—
—
2,685
27
( 27 )
—
—
—
Foreign exchange translation
loss
—
—
—
—
—
—
( 33,262 )
( 33,262 )
Net
loss
-
-
-
—
—
—
—
—
( 908,289 )
—
( 908,289 )
Balance at June 30,
2021
-
-
-
—
$ —
428,998
$ 4,288
$ 34,912,060
$ ( 15,918,557 )
$ ( 178,803 )
$ 18,818,988
Consideration paid pursuant
to amalgamation agreement
—
—
199,025
1,990
39,040,292
—
—
39,042,282
Stock-based compensation
—
—
—
—
486,986
—
—
486,986
Reserve for Ameri warrant
liabilities
—
—
—
—
( 262,491 )
—
—
( 262,491 )
Foreign exchange translation
loss
—
—
—
—
—
—
( 6,510 )
( 6,510 )
Net
loss
-
-
-
—
—
—
—
—
( 2,712,406 )
—
( 2,712,406 )
Balance at September
30, 2021
-
-
-
—
$ —
628,023
$ 6,278
$ 74,176,847
$ ( 18,630,963 )
$ ( 185,313 )
$ 55,366,849
See
the accompanying notes to the unaudited condensed consolidated financial statements.
4
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN MEZZANINE EQUITY AND SHAREHOLDERS' EQUITY
(DEFICIT) FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2022 AND 2021
Shares
Amount
Shares
Amount
Equity
Shares
Amount
Capital
Deficit
Income
Equity
Series
C Redeemable 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
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, net of offering costs
—
—
—
—
—
400,000
4,000
5,798,464
—
—
5,802,464
February registered
direct offering, net of offering costs
—
—
—
—
—
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 currency 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 embedded derivative and net of issuance costs of $ 41,962
—
—
1,000
556,038
556,038
—
—
—
—
—
—
Issuance of redeemable
Series C preferred stock
52,685
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 value
—
—
—
73,994
73,994
—
—
( 73,994 )
—
—
( 73,994 )
Conversion of RSAs into
common shares
—
—
—
—
—
1,223
12
( 12 )
—
—
—
Foreign exchange translation
loss
—
—
—
—
—
—
—
—
—
( 281,014 )
( 281,014 )
Net
loss
—
—
—
—
— -
—
—
—
( 2,790,505 )
—
( 2,790,505 )
Balance at June 30,
2022
52,685
$ 527
1,000
$ 637,840
$ 638,367 -
1,054,043
$ 10,540
$ 90,228,932
$ ( 68,050,972 )
$ ( 223,107 )
$ 21,965,393
Beginning
balance
52,685
$ 527
1,000
$ 637,840
$ 638,367 -
1,054,043
$ 10,540
$ 90,228,932
$ ( 68,050,972 )
$ ( 223,107 )
$ 21,965,393
Stock-based compensation
—
—
—
—
—
—
—
645,137
—
—
645,137
July 2022 registered direct
offering, PIPE offering, modification of warrants and exercise of pre-funded warrants, net of offering costs
—
—
—
—
—
1,000,000
10,000
3,239,125
—
—
3,249,125
Issuance of rounded shares
as a result of the reverse stock split
—
—
—
—
—
24,228
242
( 242 )
—
—
—
Preferred dividends attributable
to redeemable non-controlling interest
—
—
—
12,603
12,603
—
—
( 12,603 )
—
—
( 12,603 )
Accretion of embedded derivative
to redemption value
—
—
—
110,991
110,991
—
—
( 110,991 )
—
—
( 110,991 )
Redemption of Series C
preferred stock
( 52,685 )
( 527 )
—
—
( 527 ) -
—
—
527
—
—
527
Foreign exchange translation
loss
—
—
—
—
—
—
—
—
—
( 417,390 )
( 417,390 )
Foreign exchange translation
gain (loss)
—
—
—
—
—
—
—
—
—
( 417,390 )
( 417,390 )
Net
loss
—
—
—
—
— -
—
—
—
( 2,478,912 )
—
( 2,478,912 )
Balance at September
30, 2022
—
$ —
1,000
$ 761,434
$ 761,434 -
2,078,271
$ 20,782
$ 93,989,885
$ ( 70,529,884 )
$ ( 640,497 )
$ 22,840,286
Ending balance
—
$ —
1,000
$ 761,434
$ 761,434 -
2,078,271
$ 20,782
$ 93,989,885
$ ( 70,529,884 )
$ ( 640,497 )
$ 22,840,286
See
the accompanying notes to the unaudited condensed consolidated financial statements.
5
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
UNAUDITED
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
2022
2021
For
the Nine Months Ended September 30,
2022
2021
Cash Flows From Operating
Activities:
Net loss
$ ( 9,793,431 )
$ ( 6,871,406 )
Adjustments to reconcile
net loss to cash used in operating activities
Change in fair value of
warrant liability
( 3,845,514 )
( 7,077,376 )
Change in fair value of
investment option liability
( 1,809,622 )
—
Change in fair value of
derivative liability
284,000
—
Stock-based compensation
2,091,299
4,829,484
Inducement expense
—
298,714
Amortization of right-of-use
asset
103,365
—
Amortization of intangible
assets
126,563
482,115
Depreciation expense
114,850
2,240
Change
in operating assets and liabilities:
Prepaid expenses and other
current assets
( 758,419 )
320,123
Accounts payable and accrued
liabilities
( 106,675 )
625,748
Right-of-use
operating lease liability
( 91,022 )
—
Net
cash used in operating activities
( 13,684,606 )
( 7,390,358 )
Cash Flows From Investing
Activities:
Purchases of property and
equipment
( 577,972 )
—
Purchase of Diverse Bio
license agreement
—
( 675,000 )
Cash
accretive acquisition of MagicMed
—
3,055,327
Net
cash (used in) provided by investing activities
( 577,972 )
2,380,327
Cash Flows From Financing
Activities:
Proceeds from sale of common
stock, warrants, and investment options, net of offering costs
17,222,100
21,614,488
Proceeds from the sale
of redeemable non-controlling interest, net of offering costs (see Note 6)
958,038
—
Proceeds
from warrant exercises, net of fees
—
3,285,164
Net
cash provided by financing activities
18,180,138
24,899,652
Effect of foreign exchange
rate on cash
( 72,554 )
( 19,655 )
Net increase in cash
3,845,006
19,869,966
Cash at beginning of period
17,355,999
1,578,460
Cash at end of period
$ 21,201,005
$ 21,448,426
Supplemental disclosure
of cash and non-cash transactions:
Cash paid for interest
$ 5,114
$ 5,191
Income taxes paid
$ —
$ —
Investment options issued
in conjunction with common stock issuance
$ 4,323,734
$ —
Modification of warrants as part of share
capital raise
$ 251,357
$ —
Warrants issued in conjunction
with common stock issuance
$ 3,595,420
$ —
Issuance of embedded
derivative
$ 402,000
$ —
Preferred dividends
attributable to redeemable non-controlling interest
$ 20,411
$ —
Accretion of embedded
derivative to redemption value
$ 184,985
$ —
Issuance of Common Stock
pursuant to MagicMed amalgamation
$ —
$ 39,042,282
Deferred tax liability
incurred due to MagicMed amalgamation
$ —
$ 9,061,927
Conversion of preferred
stock to common stock
$ —
$ 32,754
Fair value of warrants issued
$ —
$ 9,981,000
Fair value of Ameri warrants
$ —
$ 262,492
See
the accompanying notes to the unaudited condensed consolidated financial statements.
6
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
1. NATURE OF BUSINESS
Nature
of Operations
Enveric
Biosciences, Inc. (“Enveric Biosciences, Inc.” “Enveric” or the “Company”) (formerly known as Ameri
Holdings, Inc.) (“Ameri”) is a pharmaceutical company developing innovative, evidence-based cannabinoid medicines. The head
office of the Company is located in Naples, Florida. The Company has the following wholly owned subsidiaries: Jay Pharma Inc. (“Jay
Pharma”), 1306432 B.C. Ltd. (“HoldCo”), MagicMed Industries, Inc. (“MagicMed”), and Enveric Canada. The
Company has an Amalgamation Agreement (“Amalgamation Agreement”) and tender agreement (“Tender Agreement”) with
Jay Pharma, which were entered into in prior years.
On
May 24, 2021, the Company entered into an Amalgamation Agreement (the “Amalgamation Agreement”) with 1306432 B.C. Ltd., a
corporation existing under the laws of the Province of British Columbia and a wholly-owned subsidiary of the Company (“HoldCo”),
1306436 B.C. Ltd., a corporation existing under the laws of the Province of British Columbia and a wholly-owned subsidiary of HoldCo
(“Purchaser”), and MagicMed Industries Inc., a corporation existing under the laws of the Province of British Columbia (“MagicMed”),
pursuant to which, among other things, the Company, indirectly through Purchaser, acquired all of the outstanding securities of MagicMed
in exchange for securities of the Company by way of an amalgamation under the British Columbia Business Corporations Act, upon the terms
and conditions set forth in the Amalgamation Agreement, such that, upon completion of the Amalgamation (as defined herein), the amalgamated
corporation (“Amalco”) will be an indirect wholly-owned subsidiary of the Company. The Amalgamation was completed on September
16, 2021.
MagicMed
Industries develops and commercializes psychedelic-derived pharmaceutical candidates. MagicMed’s psychedelic derivatives library,
the Psybrary™, is an essential building block from which industry can develop new patented products. The initial focus of the Psybrary™
is on psilocybin and DMT derivatives, and it is then expected to be expanded to other psychedelics.
Akos
Spin-Off
On
May 11, 2022, the Company announced plans to transfer and spin-off its cannabinoid clinical development pipeline assets to Akos Biosciences,
Inc. (formerly known as Acanna Therapeutics, Inc.), a majority owned subsidiary of the Company (hereafter referred to as “Akos”),
which was incorporated on April 13, 2022, by way of dividend to Enveric shareholders (the “Spin-Off”). The Spin-Off will
be subject to various conditions, including Akos meeting the qualifications for listing on the Nasdaq Stock Market, and if successful,
would result in two standalone public companies. The new company as a result of the Spin-Off will be referred to as Akos. If the Spin-Off
does not occur, the Company has guaranteed the redeemable non-controlling interest (“RNCI”).
On
May 5, 2022, the Company and Akos entered into a Securities Purchase Agreement (the “Akos Purchase Agreement”) with an accredited
investor (the “Akos Investor”), pursuant to which Akos agreed to sell to the Akos Investor up to an aggregate of 5,000 shares
of Akos’ Series A Convertible Preferred Stock (the “Akos Series A Preferred Stock”), par value $ 0.01 per share at a
price of $ 1,000 per share, and warrants (the “Akos Warrants”) to purchase shares of Akos’ common stock (the “Akos
Common Stock”), par value $ 0.01 per share, for an aggregate purchase price of up to $ 5,000,000 (the “Akos Private Placement”).
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.
Reverse
Stock Split
On
July 14, 2022 the Company affected 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.
Liquidity and Other Uncertainties
F or
the nine months ended September 30, 2022, the Company had a loss from operations of $ 15,159,453 and net cash used in operating activities
of $ 13,684,606 . As of September 30, 2022, the Company had an accumulated deficit of $ 70,529,884 . 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.
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 September 30, 2022, the Company had cash of $ 21,201,005 and
working capital of $ 19,668,572 . The Company’s cash on hand at the filing date is estimated to be sufficient to fund operations,
however, there can be no guarantee that the conditions will not change and that the Company will require additional funding, which may
not be available on acceptable terms or at all, in which case significant delays or cost increases may result in material disruption to
the Company’s operations. In such case, the Company would be required to delay, scale back or eliminate some or all of its research
and development programs, which would likely have a material adverse effect on the Company and its financial statements.
7
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
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 sufficient to fund these material cash requirements for the next twelve months.
The
Company expects to finance future cash needs through public or private equity offerings, debt financings, or business development
transactions. If adequate funds are not available, the Company may be required to delay, reduce the scope of or
eliminate research and development programs or obtain funds through arrangements with collaborators or others that may require the
Company to relinquish rights to certain pipeline candidates that they might otherwise seek to develop or commercialize
independently.
Nasdaq
Notice
On
February 18, 2022, the Company received a letter from the Listing Qualifications Department of the Nasdaq Stock Market indicating that,
based upon the closing bid price of the Company’s common stock for the 30 consecutive business day period between January 5, 2022,
through February 17, 2022, the Company did not meet the minimum bid price of $ 1.00 per share required for continued listing on the Nasdaq
Capital Market (“Nasdaq”) pursuant to Nasdaq Listing Rule 5550(a)(2). The letter also indicated that the Company will be
provided with a compliance period of 180 calendar days, or until August 17, 2022 (the “Compliance Period”), in which to regain
compliance pursuant to Nasdaq Listing Rule 5810(c)(3)(A).
On
July 29, 2022, the Company received a letter from the Listing Qualifications Department of the Nasdaq Stock Market stating that for the
last ten consecutive business days, from July 15 to July 28, 2022, the closing bid price of the Company’s common stock had been
at $ 1.00 per share or greater. Accordingly, the Company has regained compliance with Listing Rule 5550(a)(2).
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 of 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 nine months ended September 30, 2022 are not necessarily indicative of the results that may be expected for
the year ending December 31, 2022. These unaudited condensed consolidated financial statements should be read in conjunction with the
consolidated financial statements for the year ended December 31, 2021 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, 2022.
The
Company’s significant accounting policies and recent accounting standards are summarized in Note 2 of the Company’s financial
statements for the year ended December 31, 2021. There were no significant changes to these accounting policies during the three and
nine months ended September 30, 2022.
Reclassification
Certain
reclassifications have been made to the prior period financial statements to conform to the current period financial statement presentation.
Certain amounts related to depreciation and amortization from the prior period were reclassified from General and administrative line
item to Depreciation and amortization line item on the Unaudited Condensed Consolidated Statement of Operations and Comprehensive Income
(Loss). These reclassifications had no net effect on loss from operations, net loss, or cash flows as previously reported.
8
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
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, estimated fair values of long lives assets used to record impairment
charges related to intangible assets, acquired in-process research and development (“IPR&D”), and goodwill, and allocation
of purchase price in business acquisitions. Actual results could differ from those estimates.
Foreign
Currency Translation
From
inception through September 30, 2022, the reporting currency of the Company was the United States dollar while the functional currency
of the Company’s subsidiaries was the Canadian dollar. For the reporting periods ended September 30, 2022 and September 30, 2021,
the Company engaged in a number of transactions denominated in Canadian dollars. As a result, the Company is subject to exposure from
changes in the exchange rates of the Canadian dollar and the U.S. dollar.
The
Company translates the assets and liabilities of its Canadian subsidiaries into the U.S. dollar at the exchange rate in effect on the
balance sheet date. Revenues and expenses are translated at the average exchange rate in effect during each monthly period. Unrealized
translation gains and losses are recorded as foreign currency translation gain (loss), which is included in the consolidated statements
of shareholders’ equity as a component of accumulated other comprehensive income (loss).
The
Company has not entered into any financial derivative instruments that expose it to material market risk, including any instruments designed
to hedge the impact of foreign currency exposures. The Company may, however, hedge such exposure to foreign currency exchange fluctuations
in the future.
Adjustments
that arise from exchange rate changes on transactions denominated in a currency other than the local currency are included in other comprehensive
income (loss) in the consolidated statements of operations and comprehensive income (loss) as incurred.
Warrant
Liability and Investment Options
The
Company evaluates all of its financial instruments, including issued stock purchase warrants and investment options, to determine if
such instruments are derivatives or contain features that qualify as embedded derivatives, pursuant to ASC 480 and FASB ASC 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.
Modification
of Warrants
A change in any of the terms or conditions of warrants is accounted for
as a modification. For a warrant modification accounted for under ASC 815, the effect of a modification shall be measured as the difference
between the fair value of the modified warrant over the fair value of the original warrant immediately before its terms are modified,
measured based on the fair value of the shares and other pertinent factors at the modification date. The accounting for incremental fair
value of warrants is based on the specific facts and circumstances related to the modification. When a modification is directly attributable
to equity offerings, the incremental change in fair value of the warrants are accounted for as equity issuance costs.
9
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
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.
Offering
Costs
The
Company allocates offering costs to the different components of the capital raise on a pro rata basis. Any offering costs allocated to
common stock are charged directly to additional paid-in capital. Any offering costs allocated to warrant liabilities are charged to general
and administrative expenses on the Company’s unaudited condensed consolidated statement of operations.
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 nine months ended September 30, 2022
and 2021 excludes potentially dilutive securities. The computations of net loss per share for each period presented is the same for both
basic and fully diluted. In accordance with ASC 260-10-45-13, penny warrants were included in the calculation of weighted average shares
outstanding for purposes of calculating basic and diluted earnings per share.
During
the three and nine months ended September 30, 2022 the Company issued 767,500 pre-funded common stock warrants, which were exercised
on various dates during the three and nine months ended September 30, 2022. The pre-funded common stock warrants became exercisable on
July 26, 2022 based on the terms and conditions of the agreements. As the pre-funded common stock warrants are exercisable for $ 0.0001 ,
these shares are considered outstanding common shares and are included in the computation of basic and diluted Earnings Per Share as
the exercise of the pre-funded common stock warrants is virtually assured. The Company included these pre-funded common stock warrants
in basic and diluted earnings per share when all conditions were met on July 26, 2022.
Potentially
dilutive securities outlined in the table below have been excluded from the computation of diluted net loss per share for the three and
nine months ended September 30, 2022 and 2021 because the effect of their inclusion would have been anti-dilutive.
SCHEDULE
OF POTENTIALLY DILUTIVE SECURITIES
For the three and
nine months ended
September 30, 2022
For the three and
nine months ended
September 30, 2021
Warrants to purchase shares of common stock
655,463
211,534
Restricted stock units - vested and unissued
61,428
—
Restricted stock units - unvested
65,117
115,504
Restricted stock awards - vested and unissued
974
—
Restricted stock awards - unvested
—
578
Investment options to purchase shares of common stock
1,070,000
—
Options to purchase shares of common stock
22,829
22,947
Total potentially dilutive securities
1,875,811
350,563
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.
10
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Level
2 - Valuations based on observable inputs other than quoted prices included in Level 1, such as quoted prices for similar assets and
liabilities in active markets, quoted prices for identical or similar assets and liabilities in markets that are not active, or other
inputs that are observable or can be corroborated by observable market data.
Level
3 - Valuations based on unobservable inputs reflecting our own assumptions, consistent with reasonably available assumptions made by
other market participants. These valuations require significant judgment.
For
certain financial instruments, including cash, accounts receivable, and accounts payable, the carrying amounts approximate their fair
values as of September 30, 2022 and December 31, 2021 because of their short-term nature.
The
following table provides the financial liabilities measured on a recurring basis and reported at fair value on the balance sheet as of
September 30, 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:
SCHEDULE
OF FAIR VALUE HIERARCHY OF VALUATION INPUTS ON RECURRING BASIS
Level
September 30, 2022
December 31, 2021
Warrant liabilities - January 2021 Warrants
3
$ 1,011
$ 333,471
Warrant liabilities - February 2021 Warrants
3
1,101
320,203
Warrant liabilities - February 2022 Warrants
3
652,825
—
Fair value as of September 30, 2022
$ 654,937
$ 653,674
Warrant liabilities - fair value
$ 654,937
$ 653,674
Level
September 30, 2022
December 31, 2021
Derivative liability - May 2022
3
$ 686,000
$ —
Fair value as of September 30, 2022
$ 686,000
$ —
Derivative liability - fair value
$ 686,000
$ —
Level
September 30, 2022
December 31, 2021
Wainwright investment options
3
$ 139,314
$ —
RD investment options
3
890,549
—
PIPE investment options
3
1,484,249
—
Fair value as of September 30, 2022
$ 2,514,112
$ —
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.
Initial
measurement
The
Company established the initial fair value of its warrant liabilities at the respective dates of issuance. The Company used a Black Scholes
valuation model in order to determine their value. The key inputs into the Black Scholes valuation model for the initial valuations of
the warrant liabilities are below:
SCHEDULE
OF BLACK SCHOLES VALUATION MODELS OF WARRANT LIABILITIES AND INVESTMENT OPTIONS
February 2022 Warrants
February 2022 Post-Modification Warrants
February 15, 2022
July 26, 2022
Term (years)
5.0
5.5
Stock price
$ 15.75
$ 6.33
Exercise price
$ 27.50
$ 7.78
Dividend yield
— %
— %
Expected volatility
74.1 %
80.0 %
Risk free interest rate
1.9 %
2.9 %
Number of warrants
460,000
122,000
Value (per share)
$ 8.00
$ 4.07
The
Company established the initial fair value of its derivative liability at the respective date of issuance. The Company used a Weighted
Expected Return valuation model in order to determine their value. The key inputs into the Weighted Expected Return valuation model for
the initial valuations of the warrant liabilities are below:
May 2022 Derivative Liability
May 5, 2022
Principal
$ 1,000,000
Dividend rate
5.0 %
Market rate
4.4 %
11
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
The
Company established the initial fair value of its investment options at the respective dates of issuance. The Company used a Black Scholes
valuation model in order to determine their value. The key inputs into the Black Scholes valuation model for the initial valuations of
the investment options are below:
Wainwright Options
RD Options
PIPE Options
July 26, 2022
July 26, 2022
July 26, 2022
Term (years)
5.0
5.5
5.5
Stock price
$ 6.33
$ 6.33
$ 6.33
Exercise price
$ 10.00
$ 7.78
$ 7.78
Dividend yield
— %
— %
— %
Expected volatility
80.0 %
80.0 %
80.0 %
Risk free interest rate
2.9 %
2.9 %
2.9 %
Number of investment options
70,000
375,000
625,000
Value (per share)
$ 3.60
$ 4.07
$ 4.07
Subsequent
measurement
The
following table presents the changes in fair value of the warrant liabilities, derivative liability, and investment options:
SCHEDULE
OF FAIR VALUE OF WARRANT LIABILITIES AND DERIVATIVE LIABILITY AND INVESTMENT OPTIONS
Total Warrant Liabilities
Fair value as of December 31, 2021
$ 653,674
Issuance of February 2022 warrants
3,595,420
Issuance
3,595,420
Change in fair value due to modification of February 2022 warrants as part of July 2022 raise
251,357
Change in fair value
( 3,845,514 )
Fair value as of September 30, 2022
$ 654,937
Total Derivative Liability
Fair value as of December 31, 2021
$ —
Issuance of May 2022 convertible preferred stock
402,000
Change in fair value
284,000
Fair value as of September 30, 2022
$ 686,000
Total Investment Options
Fair value as of December 31, 2021
$ —
Issuance of July 2022 investment options
4,323,734
Change in fair value
( 1,809,622 )
Fair value as of September 30, 2022
$ 2,514,112
12
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
The
key inputs into the Black Scholes valuation model for the Level 3 valuations of the warrant liabilities as of September 30, 2022 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)
3.3
3.4
4.4
5.3
Stock price
$ 4.22
$ 4.22
$ 4.22
$ 4.22
Exercise price
$ 247.50
$ 245.00
$ 27.50
$ 7.78
Dividend yield
— %
— %
— %
— %
Expected volatility
78.0 %
78.0 %
80.0 %
79.0 %
Risk free interest rate
4.20 %
4.20 %
4.10 %
4.00 %
Number of warrants
36,429
34,281
338,000
122,000
Value (per share)
$ 0.03
$ 0.03
$ 1.07
$ 2.37
The
key inputs into the Weighted Expected Return valuation model for the Level 3 valuations of the derivative liability as of September 30,
2022 are below:
May 2022 Derivative Liability
Principal
$ 1,000,000
Dividend rate
5.0 %
Market rate
6.8 %
The
key inputs into the Black Scholes valuation model for the Level 3 valuations of the investment options as of September 30, 2022 are below:
Wainwright Options
RD Options
PIPE Options
Term (years)
4.8
5.3
5.3
Stock price
$ 4.22
$ 4.22
$ 4.22
Exercise price
$ 10.00
$ 7.78
$ 7.78
Dividend yield
— %
— %
— %
Expected volatility
78.0 %
79.0 %
79.0 %
Risk free interest rate
4.10 %
4.00 %
4.00 %
Number of investment options
70,000
375,000
625,000
Value (per share)
$ 1.99
$ 2.37
$ 2.37
Leases
Operating
lease assets are included within right-of-use operating lease asset and operating lease liabilities are included in current portion of
right-of-use operating lease obligation and non-current portion of right-of-use operating lease obligation on the consolidated balance
sheet as of September 30, 2022. The Company has elected not to present short-term leases as these leases have a lease term of 12 months
or less at lease inception and do not contain purchase options or renewal terms that the Company is reasonably certain to exercise. All
other lease assets and lease liabilities are recognized based on the present value of lease payments over the lease term at commencement
date. Because most of the Company’s leases do not provide an implicit rate of return, the Company used an incremental borrowing
rate based on the information available at adoption date in determining the present value of lease payments.
13
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Redeemable
Non-controlling Interest
In
connection with the issuance of Akos Series A Preferred Stock, the Akos Purchase Agreement and certificate of designation contain a put
right guaranteed by the Company as defined in Note 6. Applicable accounting guidance requires an equity instrument that is redeemable
for cash or other assets to be classified outside of permanent equity if it is redeemable (a) at a fixed or determinable price on a fixed
or determinable date, (b) at the option of the holder, or (c) upon the occurrence of an event that is not solely within the control of
the issuer. As a result of this feature, the Company recorded the non-controlling interests as redeemable non-controlling interests and
classified them in temporary equity within its 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.
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, plus all the accrued but unpaid dividends per share. Pursuant to the Akos Purchase Agreement, the Company has guaranteed
the payment of the purchase price for the shares purchased under the Put Right.
Segment
Reporting
The
Company determines its reporting units in accordance with FASB ASC 280, “Segment Reporting” (“ASC 280”). The
Company evaluates a reporting unit by first identifying its operating segments under ASC 280. The Company then evaluates each operating
segment to determine if it includes one or more components that constitute a business. If there are components within an operating segment
that meet the definition of a business, the Company evaluates those components to determine if they must be aggregated into one or more
reporting units. If applicable, when determining if it is appropriate to aggregate different operating segments, the Company determines
if the segments are economically similar and, if so, the operating segments are aggregated. The Company has multiple operations related
to psychedelics and cannabinoids. Both of these operations exist under one reporting unit: Enveric. The Company has one operating segment
and reporting unit. The Company is organized and operated as one business. Management reviews its business as a single operating segment,
using financial and other information rendered meaningful only by the fact that such information is presented and reviewed in the aggregate.
3.
INTANGIBLE ASSETS AND GOODWILL
As
of September 30, 2022, the Company’s intangible assets consisted of:
SCHEDULE OF GOODWILL INDEFINITE AND FINITE LIVED INTANGIBLE ASSETS
Goodwill
Balance at December 31, 2021
$ 1,587,634
Loss on currency translation
( 119,245 )
Balance at September 30, 2022
$ 1,468,389
Indefinite lived intangible assets
Balance at December 31, 2021
$ 6,375,492
Loss on currency translation
( 478,856 )
Balance at September 30, 2022
$ 5,896,636
Definite lived intangible assets
Balance at December 31, 2021
$ 548,436
Amortization
( 126,563 )
Balance at September 30, 2022
$ 421,873
For
goodwill, identified indefinite lived assets, and identified definite lived intangible assets, there was no impairment expense during
the three and nine months ended September 30, 2022 and 2021. For identified definite lived intangible assets, amortization expense amounted
to $ 42,187 and $ 170,692 during the three months ended September 30, 2022 and 2021, respectively. For identified definite lived intangible
assets, amortization expense amounted to $ 126,563 and $ 482,115 during the nine months ended September 30, 2022 and 2021, respectively.
14
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
The
Company amortizes definite lived intangible assets on a straight-line basis over their estimated useful lives. Amortization expense
of identified intangible assets based on the carrying amount as of September 30, 2022 is as follows:
SCHEDULE OF FINITE LIVED INTANGIBLE ASSETS AMORTIZATION EXPENSES
Year ending December 31,
2022 (excluding the nine months ended September 30)
$ 42,187
2023
168,750
2024
168,750
2025
42,186
Finite
lived Assets Amortization Expense
$ 421,873
4.
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
September 30, 2022
December 31, 2021
Lab equipment
$ 819,988
$ 310,957
Computer equipment
24,841
10,818
Property
and Equipment, gross
Less: Accumulated depreciation
( 131,885 )
( 27,345 )
Property and equipment, net of accumulated depreciation
$ 712,944
$ 294,430
Depreciation
expense was $ 44,458 and $ 2,240 for the three months ended September 30, 2022 and 2021, respectively. Depreciation expense was $ 114,850
and $ 2,240 for the nine months ended September 30, 2022 and 2021, respectively.
5.
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 September 30, 2022, 100,000,000 shares of common stock were authorized under the Company’s articles of
incorporation.
On
December 30, 2020, the Company amended its articles of incorporation to designate and authorize 20,000,000 shares of preferred stock.
The Company issued Series B preferred stock (“Series B Preferred Stock), which has a certificate of designation authorizing issuance
of 3,600,000 preferred shares. During the three months ended March 31, 2021, holders of an aggregate of 65,509 shares of Series B Preferred
Stock converted their shares into 65,509 shares of common stock. Following those conversions, no Series B Preferred stock shares remain
outstanding.
Series
C Preferred Shares
On
May 3, 2022, the Board of Directors (the “Board”) declared a dividend of one one-thousandth of a share of the Company’s
Series C Preferred Stock (“Series C Preferred Stock”) for each outstanding share of the Company’s Common Stock (the
“Common Stock”) held of record as of 5:00 p.m. Eastern Time on May 13, 2022 (the “Record Date”). This dividend
was based on the number of outstanding shares of Common Stock prior to the Reverse Stock Split. The outstanding shares of Series C Preferred
Stock were entitled to vote together with the outstanding shares of the Company’s Common Stock, as a single class, exclusively
with respect to a proposal giving the Board the authority, as it determines appropriate, to implement a reverse stock split within twelve
months following the approval of such proposal by the Company’s stockholders (the “Reverse Stock Split Proposal”),
as well as any proposal to adjourn any meeting of stockholders called for the purpose of voting on the Reverse Stock Split Proposal (the
“Adjournment Proposal”).
15
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
The
Company held a special meeting of stockholders on July 14, 2022 (the “Special Meeting”) for the purpose of voting on, among
other proposals, a Reverse Stock Split Proposal and an Adjournment Proposal. All shares of Series C Preferred Stock that were not present
in person or by proxy at the Special Meeting were automatically redeemed by the Company immediately prior to the opening of the polls
at Special Meeting (the “Initial Redemption”). All shares that were not redeemed pursuant to the Initial Redemption were
redeemed automatically upon the approval by the Company’s stockholders of the Reverse Stock Split Proposal at the Special Meeting
(the “Subsequent Redemption” and, together with the Initial Redemption, the “Redemption”). Each share of Series
C Preferred Stock was entitled to receive $0.10 in cash for each 10 whole shares of Series C Preferred Stock immediately prior to the
Redemption. As of June 30, 2022, there were 52,684 .548 shares of Series C Preferred Stock issued and outstanding. As of September 30,
2022, both the Initial Redemption and the Subsequent Redemption have occurred. As a result, no shares of Series C Preferred Stock remain
outstanding.
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.
During
the nine months ended September 30, 2022, a total of 2,122 shares of Common Stock were issued pursuant to the conversion of restricted
stock units.
16
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Stock
Options
Amendment
to 2020 Long-Term Incentive Plan
On
May 3, 2022, our Board adopted the First Amendment (the “Plan Amendment”) to the Enveric Biosciences, Inc. 2020 Long-Term
Incentive Plan (the “Incentive Plan”) to (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 stockholders at a special meeting of the Company’s stockholders held on July 14,
2022.
A
summary of activity under the Company’s incentive plan for the nine months ended September 30, 2022 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, 2021
23,829
$ 79.00
$ 103.50
5.3
$ 34,333
Forfeited
( 1,000 )
$ 175.00
$ 140.50
—
—
Outstanding at September 30, 2022
22,829
$ 75.00
$ 101.50
4.3
$ —
Exercisable at September 30, 2022
19,690
$ 74.93
$ 101.00
3.8
$ —
The
Company’s stock based compensation expense, recorded within general and administrative expense, related to stock options for the
three months ended September 30, 2022 and 2021 was $ 48,697 and $ 4,683 , respectively. The Company’s stock based compensation expense,
recorded within general and administrative expense, related to stock options for the nine months ended September 30, 2022 and 2021
was $ 134,383 and $ 4,683 , respectively. As of September 30, 2022, the Company had $ 222,501 in unamortized stock option expense, which
will be recognized over a weighted average period of 1.3 years.
During
the nine months ended September 30, 2021, the Company exchanged options to purchase 11,209 shares of common stock for 6,509 restricted
stock units and 843 restricted stock awards. In connection with this exchange, the Company recognized $ 298,714 in inducement expense
related to the increase in fair value of the new awards over the old awards, which is included in other expenses on the Company’s
consolidated statement of operations and comprehensive income (loss).
Restricted
Stock Awards
The
Company’s activity in restricted common stock was as follows for the nine months ended September 30, 2022:
SCHEDULE OF RESTRICTED STOCK UNITS AND AWARDS ACTIVITY
Number of shares
Weighted average fair value
Non-vested at December 31, 2021
1,031
$ 141.50
Forfeited
( 700 )
$ 146.50
Vested
( 331 )
$ 130.40
Non-vested at September 30, 2022
—
$ —
For
the three months ended September 30, 2022 and 2021, the Company recorded $ 6,250 and $ 23,995 , respectively, in stock-based compensation
expense within general and administrative expense, related to restricted stock awards. For the nine months ended September 30, 2022 and
2021, the Company recorded $ 24,363 and $ 80,109 , respectively, in stock-based compensation expense within general and administrative expense,
related to restricted stock awards. As of September 30, 2022, there were no unamortized stock-based compensation costs related to restricted
share awards. The balance of Common Shares related to the vested restricted stock awards as of September 30, 2022 will be issued during
the 2022 calendar year. There are 974 vested and unissued shares of restricted stock awards as of September 30, 2022.
17
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Issuance
of Restricted Stock Units
The
Company’s activity in restricted stock units was as follows for the nine months ended September 30, 2022:
SCHEDULE OF RESTRICTED STOCK UNITS AND AWARDS ACTIVITY
Number of shares
Weighted average fair value
Non-vested at December 31, 2021
62,013
$ 126.00
Granted
37,445
$ 33.50
Forfeited
( 26,772 )
$ 79.64
Vested
( 7,569 )
$ 140.60
Non-vested at September 30, 2022
65,117
$ 92.02
For
the three months ended September 30, 2022 and 2021, the Company recorded $ 590,190 and $ 458,308 , respectively, in stock-based compensation
expense related to restricted stock units. For the nine months ended September 30, 2022 and 2021, the Company recorded $ 1,932,553 and
$ 4,710,225 , 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 unaudited condensed consolidated statement of operations.
As
of September 30, 2022, the Company had unamortized stock-based compensation costs related to restricted stock units of $ 5,858,048 which
will be recognized over a weighted average period of 3.0 years and unamortized stock-based costs related to restricted stock units which
will be recognized upon achievement of specified milestones.
As
of September 30, 2022, 1,856 shares of Common Stock have been issued in relation to vested restricted stock units and 61,428 restricted
stock units are vested without shares of Common Stock being issued.
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
Stock-based compensation for RSU
2022
2021
2022
2021
Three months ended September 30,
Nine months ended September 30,
Stock-based compensation for RSU
2022
2021
2022
2021
General and administrative
$ 357,756
$ 315,929
$ 1,138,080
$ 4,592,748
Research and development
232,434
118,474
794,473
118,474
Total
$ 590,190
$ 434,403
$ 1,932,553
$ 4,711,222
Warrants
On
February 11, 2022, the Company entered into an underwriting agreement (the “Underwriting Agreement”) with A.G.P./Alliance
Global Partners (the “Underwriter”). Pursuant to the Underwriting Agreement, the Company agreed to sell, in a firm commitment
offering, 400,000 shares of the Company’s Common Stock and accompanying warrants to purchase up to an aggregate of 400,000 shares
of its common stock (“February 2022 Warrants”), as well as up to 60,000 additional shares of common stock and/or warrants
to purchase an aggregate of up to 60,000 shares of its common stock that may be purchased by the Underwriter pursuant to a 45-day option
granted to the Underwriter by the Company (the “Offering”). Each share of common stock was sold together with a common warrant
to purchase one share of common stock, at an exercise price of $ 27.50 per share. Such common warrants were immediately exercisable and
will expire five years from the date of issuance. There is not expected to be any trading market for the common warrants issued in the
Offering. The combined public offering price of each share of common stock and accompanying common warrant sold in the Offering was $ 25.00 .
On February 14, 2022, the Underwriter exercised its option to purchase an additional 60,000 warrants.
In
connection with the Registered Direct (“RD”) Offering and the Private Investment in Public Entity (“PIPE”) Offering
entered into on July 22, 2022, the Company entered into Warrant Amendment (the “Warrant Amendments”) with the investors in
both offerings to amend certain existing warrants to purchase up to an aggregate of 122,000 shares of Common Stock that were previously
issued to the investors, with an exercise price of $ 27.50 per share (subsequent to the 1-for-50 reverse stock split that occurred on
July 14, 2022) and expiration date of February 15, 2027 . Pursuant to the Warrant Amendments, the previously issued warrants were amended,
effective upon the closing of the offerings, so that the amended warrants have a reduced exercise price of $ 7.78 per share and expire
five and one-half years following the closing of the offerings. In connection with this transaction, the Company determined the fair
value of the February 2022 Warrants immediately prior to the Warrant Amendment and the fair value of the amended warrants immediately
after the Warrant Amendment. The incremental change in fair value was deemed to be $ 251,357 , which was included as equity issuance costs
related to the RD and PIPE financing transactions.
18
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Preferred Investment Options
In
connection with the Registered Direct Securities Purchase Agreement the Company issued unregistered preferred investment options to
purchase up to 375,000 shares
of common stock. Subject to certain ownership
limitations, the RD Preferred Investment Options became immediately exercisable at an exercise price equal to $ 7.78 per
share of common stock. The RD Preferred Investment Options are exercisable for five and one-half years from the date of
issuance.
In
connection with the PIPE Securities Purchase Agreement the Company issued unregistered preferred investment options to purchase
up to 625,000 shares
of the common stock. Subject to certain ownership limitations, PIPE Preferred Investment Options became immediately exercisable at
an exercise price equal to $ 7.78 per
share of common stock. The PIPE Preferred Investment Options are exercisable for five and one-half years from the date of
issuance
On
July 26, 2022, in connection with the RD Offering and PIPE Offering, the Company issued preferred investment options (the “Placement
Agent Preferred Investment Options”) to an entity to purchase up to 70,000 shares of the common stock for acting as a placement
agent. The Placement Agent Preferred Investment Options have substantially the same terms as the RD Preferred Investment Options and
the PIPE Preferred Investments Options, except the Placement Agent Preferred Investment Options have an exercise price of $ 10.00 per
share. The Placement Agent Preferred Investment Options are exercisable for five years from the date of the commencement of the RD Offering and PIPE Offering.
The
following table summarizes information about shares issuable under warrants outstanding at September 30, 2022:
SCHEDULE
OF WARRANTS AND INVESTMENT OPTIONS
Warrant shares outstanding
Weighted average exercise price
Weighted average remaining life
Intrinsic value
Outstanding at December 31, 2021
195,463
$ 131.00
3.4
$ 801,024
Issued
1,227,500
$ 10.31
$ —
Exercised
( 767,500 )
$ —
—
$ —
Outstanding at September 30, 2022
655,463
$ 58.36
3.8
$ 5,514
Exercisable at September 30, 2022
655,463
$ 58.36
3.8
$ 5,514
The
warrants assumed pursuant to the acquisition of MagicMed contain certain down round features, which were not triggered by the February
2022 public offering or the July 2022 public offering, that would require adjustment to the exercise price upon certain events when the
offering price is less than the stated exercise price.
The
following table summarizes information about investment options outstanding at September 30, 2022:
Investment options outstanding
Weighted average exercise price
Weighted average remaining life
Intrinsic value
Outstanding at January 1, 2021
—
$ —
—
$ —
Issued
1,070,000
$ 7.93
5.5
—
Outstanding at September 30, 2021
1,070,000
$ 7.93
5.3
$ —
Exercisable at September 30, 2021
1,070,000
$ 7.93
5.3
$ —
19
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
6.
REDEEMABLE NON-CONTROLLING INTEREST
Spin-Off
and Related Private Placement
In
connection with the planned Spin-Off, on May 5, 2022, Akos and the Company entered into the Akos Purchase Agreement with the Akos Investor,
pursuant to which Akos agreed to sell up to an aggregate of 5,000 shares of Akos Series A Preferred Stock, at price of $ 1,000 per share,
and 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 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 shall be paid to Palladium in the form of convertible preferred stock and warrants on similar terms to the securities
issued in the Akos Private Placement. As of June 30, 2022, there have been no accruals recorded for the fees or warrants since the closing
of the spin-off is not probable. Palladium is 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.
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.
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.
20
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Accounting
for Akos Series A Preferred Stock
Since
the shares of Akos Series A Preferred Stock are redeemable at the option of the holder and the redemption is not solely in the control
of the Company, the shares of Akos Series A Preferred Stock are accounted for as a redeemable non-controlling interest and classified
within temporary equity in the Company’s consolidated balance sheets. The redeemable non-controlling interest was initially measured
at fair value. Dividends on the shares of Akos Series A Preferred Stock are recognized as preferred dividends attributable to redeemable
non-controlling interest in the Company’s unaudited condensed consolidated statement of operations.
The
table below presents the reconciliation of changes in redeemable non-controlling interest:
SCHEDULE OF RECONCILIATION CHANGE IN REDEEMBALE NONCONTROLLING INTEREST
Balance at December 31, 2021
$ —
Redeemable non-controlling interest, net of initial value embedded derivative of $ 402,000 and net of issuance costs of $ 41,962
556,038
Preferred dividends attributable to redeemable non-controlling interest
20,411
Accretion of embedded derivative and transaction costs to redemption value
184,985
Balance at September 30, 2022
$ 761,434
As
of September 30, 2022, the redemption value of the redeemable non-controlling interest is $ 1,000,000 plus cumulative dividends which
accrue at the rate of 5 % annually, or approximately $ 1,020,000 . The Company has guaranteed this redemption on behalf of Akos.
7.
COMMITMENTS AND CONTINGENCIES
The
Company is periodically involved in legal proceedings, legal actions and claims arising in the normal course of business. Management
believes that the outcome of such legal proceedings, legal actions and claims will not have a significant adverse effect on the Company’s
financial position, results of operations or cash flows.
Development
and Clinical Supply Agreement
On
February 22, 2021, the Company entered into a Development and Clinical Supply Agreement (the “PureForm Agreement”) with PureForm
Global, Inc. (“PureForm”), pursuant to which PureForm will be the exclusive provider of synthetic cannabidiol (“API”)
for the Company’s development plans for cancer treatment and supportive care. Under the terms of the PureForm Agreement, PureForm
has granted the Company the exclusive right to purchase API and related product for cancer treatment and supportive care during the term
of the Agreement (contingent upon an initial minimum order of 1 kilogram during the first thirty (30) days from the effective date) and
has agreed to manufacture, package and test the API and related product in accordance with specifications established by the parties.
All inventions that are developed jointly by the parties in the course of performing activities under the PureForm Agreement will be
owned jointly by the parties in accordance with applicable law; however, if the Company funds additional research and development efforts
by PureForm, the parties may enter into a further agreement whereby PureForm would assign any resulting inventions or technical information
to the Company.
The
initial term of the PureForm Agreement is three (3) years commencing on the effective date of the PureForm Agreement, subject to extension
by mutual agreement of the parties. The PureForm Agreement may be terminated by either party upon thirty (30) days written notice of
an uncured material breach or immediately in the event of bankruptcy or insolvency. The PureForm Agreement contains, among other provisions,
representation and warranties, indemnification obligations and confidentiality provisions in favor of each party that are customary for
an agreement of this nature.
The
Company has met the minimum purchase requirement of 1 kilogram during the first thirty days of the PureForm Agreement’s effectiveness.
21
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Purchase
agreement with Prof. Zvi Vogel and Dr. Ilana Nathan
On
December 26, 2017, Jay Pharma entered into a purchase agreement with Prof. Zvi Vogel and Dr. Ilana Nathan (the “Vogel-Nathan Purchase
Agreement”), pursuant to which Jay Pharma was assigned ownership rights to certain patents, which were filed and unissued as of
the date of the Vogel-Nathan Purchase Agreement. The Vogel-Nathan Purchase Agreement includes a commitment to pay a one-time milestone
totaling $ 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.
Agreement
with Tikkun
License
Agreement
Jay
Pharma, Tikkun Olam LLC (“TO LLC”) and Tikkun Olam Hemp LLC (“TOH”) entered into a license agreement dated on
January 10, 2020, pursuant to which Jay Pharma would acquire certain in-licensed and owned intellectual property rights related to the
cannabis products in the United States (presently excluding the state of New York) from TO LLC and TOH, each of which is an affiliate
of TO Holdings Group LLC, in exchange for royalty payments of (i) four percent (4.0%) of net sales of OTC cancer products made via consumer
channels; and (ii) five percent (5.0%) of net sales of beauty products made via consumer channels; and (iii) three percent (3.0%) of
net sales of OTC cancer products made via professional channels, along with a minimum net royalty payment starting in January 1, 2022
and progressively increasing up to a cap of $400,000 maximum each year for the first 10 years, then $600,000 maximum each year for the
next 5 years, and an annual maximum cap of $750,000 each year thereafter during the term of the agreement . The licensed intellectual
property rights relate to beauty products and OTC cancer products, and branding rights related thereto. The beauty products include any
topical or transdermal cannabis-containing or cannabis-derived (including hemp-based) skin care or body care beauty products, and the
OTC cancer products means any cancer-related products, in each case excluding those regulated as a drug, medicine, or controlled substance
by the FDA or any other relevant governmental authority, such as the USDA.
On
August 12, 2020, Jay Pharma, TO LLC and TOH entered into the First Amendment to the License Agreement, pursuant to which all references
to the Original Amalgamation Agreement and the amalgamation were revised to be references to the Tender Agreement and the Offer, as applicable.
On
October 2, 2020, Jay Pharma, TO LLC and TOH entered into the Second Amendment to the License Agreement, pursuant to which the effective
date of the transactions was revised to occur as of October 2, 2020.
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 15 months. These agreements, in aggregate, commit the Company to approximately $ 2.4 million in future
cash.
8.
INCOME TAXES
On
September 16, 2021, the Company acquired MagicMed. In connection with the acquisition, the Company recorded intangible assets from IPR&D
valued at $ 35,500,000 ,
which would be tested for impairment for book purposes, but without a tax basis, creating a deferred tax liability of $ 9,061,927 .
The deferred tax liability decreased to $ 1,607,122
due to an impairment on intangible assets of
$ 29,048,164
and an impairment of goodwill of $ 8,225,862
for the year ended December 31, 2021. As of September
30, 2022, the balance of the deferred tax liability is $ 1,486,413 .
22
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 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
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 (“PPACA”);
●
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;
●
the effect that the reverse stock split of our common stock effected on
July 14, 2022 may have on the price of our common stock; and
●
our success at managing the risks involved in the foregoing.
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 on Form 10-K filed with the SEC on March 31, 2022. 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.
23
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 derivatives (“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 artificial intelligence (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
are also aiming 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.
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 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 Food and Drug Administration
(“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.
24
Recent
Developments
Reverse
Stock Split
On
July 14, 2022, the Company filed a Certificate of Amendment of Amended and Restated Certificate of Incorporation (the “Certificate
of Amendment”) with the Secretary of State of Delaware to effect a 1-for-50 reverse stock split of the shares of the Company’s
common stock, par value $0.01 per share (the “Common Stock”), either issued and outstanding or held by the Company as treasury
stock, effective as of 4:05 p.m. (New York time) on July 14, 2022 (the “Reverse Stock Split”). The Company held a special
meeting of stockholders (the “Special Meeting”), during which the Company’s stockholders approved the amendment to
the Company’s Amended and Restated Certificate of Incorporation, as amended (the “Certificate of Incorporation”), to
effect a reverse stock split of the Company’s common stock at a ratio in the range of 1-for-10 to 1-for-100, with such ratio to
be determined by the Company’s board of directors (the “Board”) and included in a public announcement. Following the
meeting, the Board determined to effect the Reverse Stock Split at a ratio of 1-for-50 and approved the corresponding final form of the
Certificate of Amendment.
As
a result of the Reverse Stock Split, every 50 shares of issued and outstanding Common Stock were automatically combined into one issued
and outstanding share of Common Stock, without any change in the par value per share. No fractional shares were issued as a result of
the Reverse Stock Split. Any fractional shares that would otherwise have resulted from the Reverse Stock Split were rounded up to the
next whole number. The Reverse Stock Split reduced the number of shares of Common Stock outstanding from 52,684,548 shares to 1,054,043
shares. The number of authorized shares of Common Stock under the Certificate of Incorporation remained unchanged at 100,000,000 shares.
All historical share and per share amounts reflected throughout this report have been adjusted to reflect the Reverse Stock Split described
above.
Proportionate
adjustments were made to the per share exercise price and the number of shares of Common Stock that may be purchased upon exercise of
outstanding stock options granted by the Company, and the number of shares of Common Stock reserved for future issuance under the Company’s
2020 Long-Term Incentive Plan.
February
2022 Offering
On
February 15, 2022, we completed a public offering of 400,000 shares of Common Stock and warrants to purchase up to 20,000,000 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, we 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, we 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.
Series
C Preferred Shares
On
May 3, 2022, the Board of Directors (the “Board”) declared a dividend of one one-thousandth of a share of the Company’s
Series C Preferred Stock (“Series C Preferred Stock”) for each outstanding share of the Company’s Common Stock (the
“Common Stock”) held of record as of 5:00 p.m. Eastern Time on May 13, 2022 (the “Record Date”). This dividend
was based on the number of outstanding shares of Common Stock prior to the Reverse Stock Split. The outstanding shares of Series C Preferred
Stock were entitled to vote together with the outstanding shares of the Company’s Common Stock, as a single class, exclusively
with respect to a proposal giving the Board the authority, as it determines appropriate, to implement a reverse stock split within twelve
months following the approval of such proposal by the Company’s stockholders (the “Reverse Stock Split Proposal”),
as well as any proposal to adjourn any meeting of stockholders called for the purpose of voting on the Reverse Stock Split Proposal (the
“Adjournment Proposal”).
The
Company held a special meeting of stockholders on July 14, 2022 (the “Special Meeting”) for the purpose of voting on, among
other proposals, a Reverse Stock Split Proposal and an Adjournment Proposal. All shares of Series C Preferred Stock that were not present
in person or by proxy at the Special Meeting were automatically redeemed by the Company immediately prior to the opening of the polls
at Special Meeting (the “Initial Redemption”). All shares that were not redeemed pursuant to the Initial Redemption were
redeemed automatically upon the approval by the Company’s stockholders of the Reverse Stock Split Proposal at the Special Meeting
(the “Subsequent Redemption” and, together with the Initial Redemption, the “Redemption”). Each share of Series
C Preferred Stock was entitled to receive $0.10 in cash for each 10 whole shares of Series C Preferred Stock immediately prior to the
Redemption. As of August 12, 2022, both the Initial Redemption and the Subsequent Redemption occurred. As a result, as of September 30,
2022, no shares of Series C Preferred Stock remain outstanding.
25
The
Company was not solely in control of redemption of the shares since the holders had the option of deciding whether to return a proxy
card for the Special Meeting, which determine whether a given holder’s shares of Series C Preferred Stock were redeemed in the
Initial Redemption or the Subsequent Redemption. Since the redemption of the Series C Preferred Stock was not solely in the control of
the Company, the preferred shares are classified within temporary equity in the Company’s unaudited condensed consolidated balance
sheets. The preferred shares were initially measured at redemption value. As of September 30, 2022, no shares of Series C Preferred Stock
are outstanding.
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 Convertible Preferred Stock, par value $0.01 per share (the “Akos Series A
Preferred Stock”), at price of $1,000 per share, and warrants (the “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 a non-controlling interest (“NCI”) (see Note 2). Palladium Capital Advisors, LLC (“Palladium”) acted as placement
agent for the 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 shall be paid to Palladium in the form of convertible preferred stock and warrants on similar terms to
the securities issued in the Akos Private Placement. As of September 30, 2022, there have been no accruals recorded for the fees or warrants
since the closing of the spin-off is not probable. Palladium is 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.
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, 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 below).
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. Pursuant to the Akos Purchase Agreement,
the Company has guaranteed the payment of the purchase price for the shares purchased under the Put Right. 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. 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.
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. As of September 30, 2022, there is no accrual recorded since the closing of the
spin-off is not probable.
26
Amendment
to 2020 Long-Term Incentive Plan
On
May 3, 2022, our Board adopted the First Amendment (the “Plan Amendment”) to the Enveric Biosciences, Inc. 2020 Long-Term
Incentive Plan (the “Incentive Plan”) to (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 stockholders at a special meeting of the Company’s stockholders held on July 14,
2022.
July
2022 Offerings
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, 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. Shares of common stock and RD Pre-Funded Warrants issued in the RD Offering were offered pursuant to a “shelf”
registration statement on Form S-3 previously filed with the SEC on July 2, 2021. 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. There is not expected
to be any trading market for the common warrants issued in the RD Offering. On August 3, 2022, all of the issued RD Pre-Funded Warrants
were exercised. Subject to certain ownership limitations, the RD Preferred Investment Options became immediately exercisable at an exercise
price equal to $7.78 per share of common stock. The RD Preferred Investment Options are exercisable for five and one-half years from
the date of issuance.
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, 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. There is not expected to be any trading market for the common warrants issued in the PIPE
Offering. All of the issued PIPE Pre-Funded Warrants were exercised on various dates prior to August 18, 2022. Subject to certain ownership
limitations, PIPE Preferred Investment Options became immediately exercisable at an exercise price equal to $7.78 per share of common
stock. The PIPE Preferred Investment Options are exercisable for five and one-half years from the date of issuance.
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.
On
July 26, 2022, in connection with the RD Offering and PIPE Offering, the Company issued preferred investment options (the “Placement
Agent Preferred Investment Options”) to an entity to purchase up to 70,000 shares of the common stock for acting as a placement
agent. The Placement Agent Preferred Investment Options have substantially the same terms as the RD Preferred Investment Options and
the PIPE Preferred Investments Options, except the Placement Agent Preferred Investment Options have an exercise price of $10.00 per
share. The Placement Agent Preferred Investment Options are exercisable for five years from the date of issuance.
In
connection with the RD Offering and the PIPE, the Company entered into Warrant Amendment Agreements (the “Warrant Amendments”)
with the investors in both offerings to amend certain existing warrants to purchase up to an aggregate of 122,000 shares of Common Stock
that were previously issued to the investors on February 15, 2022, with an exercise price of $27.50 per share and expiration date of
February 15, 2027. Pursuant to the Warrant Amendments, the previously issued warrants were amended, effective upon the closing of the
offerings, so that the amended warrants have a reduced exercise price of $7.78 per share and expire five and one-half years following
the closing of the offerings. The Company determined the fair value of the February 2022 Warrants immediately prior to the Warrant Amendment
and the fair value of the amended warrants immediately after the Warrant Amendment. The incremental change in fair value was deemed to
be $251,357, which was included as equity issuance costs related to the RD and PIPE financing transactions.
27
Results
of Operations
The
following table sets forth information comparing the components of net loss for the three months ended September 30, 2022 and 2021:
For the Three Months Ended September 30,
2022
2021
Operating expenses
General and administrative
$ 3,514,547
$ 2,123,834
Research and development
2,055,656
1,219,339
Depreciation and amortization
86,646
173,696
Total operating expenses
5,656,849
3,516,869
Loss from operations
(5,656,849 )
(3,516,869 )
Other income (expense)
Change in fair value of warrant liabilities
1,599,623
804,833
Change in fair value of investment option liability
1,809,622
—
Change in fair value of derivative liability
(231,000 )
—
Interest expense
(308 )
(370 )
Total other income
3,177,937
804,463
Net loss
(2,478,912 )
(2,712,406 )
Less preferred dividends attributable to non-controlling interest
12,603
—
Less deemed dividends attributable to accretion of embedded derivative at redemption value
110,991
—
Net loss attributable to shareholders
(2,602,506 )
(2,712,406 )
Other comprehensive loss
Foreign currency translation
(417,390 )
(6,510 )
Comprehensive loss
$ (3,019,896 )
$ (2,718,916 )
Net loss per share - basic and diluted
$ (1.46 )
$ (5.91 )
Weighted average shares outstanding, basic and diluted
1,787,235
459,289
General
and Administrative Expenses
Our general and administrative
expenses increased to $3,514,547 for the three months ended September 30, 2022 from $2,123,834 for the three months ended September 30,
2021, an increase of $1,390,713, or 65%. This change was primarily driven by an increase in marketing fees of $143,578, an increase in
professional fees of $234,911, and an increase in transaction expenses from equity offerings of $704,092.
Research
and Development Expenses
Our
research and development expense for the three months ended September 30, 2022 was $2,055,656 compared to $1,219,339 for the three months
ended September 30, 2021 an increase of $836,317, or 69%. This increase was primarily driven by increased product development activities
during the current year, as compared to the prior year, in particular, research relating to psychedelic molecules, activities which the
Company was not engaged in during the comparable period of the prior year. In addition, there was an increase in research and development stock-based compensation of $113,960 during the three months ended September
30, 2022 as compared to the same period in 2021.
28
Depreciation
and Amortization Expense
Depreciation and
amortization expense for the three months ended September 30, 2022 was $86,646 as compared to $173,696 for the three months
ended September 30, 2021, a decrease of $87,050, or approximately 50%. The decrease in amortization is due to amortization of
approximately $128,511 recorded for the Skincare license during the three months ended September 30, 2021. The Skincare license was
subsequently fully impaired in the fourth quarter of 2021, resulting in no amortization of the Skincare license during 2022. This
decrease was offset by an increase in depreciation of $42,218 during the three months ended September 30, 2022 as compared to
the three months ended September 30, 2021.
Change
in Fair Value of Warrant Liabilities
The
Company’s change in fair value warrant liabilities was increased by $794,790 for the three months ended September 30, 2022 as compared
to for the three months ended September 30, 2021, due primarily to a decrease in the Company’s stock price in the current period.
Change
in Fair Value of Investment Option Liability
The
Company’s change in fair value of investment option liability was $1,809,622 for the three months ended September 30, 2022.
The Company did not have any outstanding investment option liabilities during the three months ended September 30, 2021. The change
in fair value is due to the significant decrease in the Company’s stock price between the issuance of the investment option liability
and September 30, 2022. The Company’s stock price was $6.33 on July 26, 2022 (the date of issuance) and $4.22 on September 30, 2022,
a decrease of approximately 33% during that time.
Change
in Fair Value of Derivative Liability
The Company’s change in fair value of derivative liability increased
by $231,000 for the three months ended September 30, 2022 as compared to for the three months ended September 30, 2021, due
primarily to the announcement of the planned spin-off of Akos.
Foreign
Currency Translation
Our
foreign currency translation loss was $417,390 for the three months ended September 30, 2022 as compared to a loss of $6,510 for the
three months ended September 30, 2021, for a change in loss of $410,880. The increase in foreign exchange loss is primarily due to the
U.S. Dollar fluctuating against the Canadian Dollar and the conversion of the Canadian Dollars into United States Dollars for payment
of United States Dollar denominated expenses. In addition, the Company engaged in a significantly higher number of transactions denominated
in Canadian dollars during the three months ended September 30, 2022, as compared to the three months ended September 30, 2021, resulting
in a much larger effect of foreign currency translation on the Company’s operations.
29
The
following table sets forth information comparing the components of net loss for the nine months ended September 30, 2022 and the comparable
period in 2021:
For the Nine Months Ended September 30,
2022
2021
Operating expenses
General and administrative
$ 8,783,619
$ 10,864,696
Research and development
6,134,421
2,295,826
Depreciation and amortization
241,413
484,355
Total operating expenses
15,159,453
13,644,877
Loss from operations
(15,159,453 )
(13,644,877 )
Other income (expense)
Inducement expense
—
(298,714 )
Change in fair value of warrant liabilities
3,845,514
7,077,376
Change in fair value of investment option liability
1,809,622
—
Change in fair value of derivative liability
(284,000 )
—
Interest expense
(5,114 )
(5,191 )
Total other income
5,366,022
6,773,471
Net loss
$ (9,793,431 )
$ (6,871,406 )
Less preferred dividends attributable to non-controlling interest
20,411
—
Less deemed dividends attributable to accretion of embedded derivative at redemption value
184,985
—
Net loss attributable to shareholders
(9,998,827 )
(6,871,406 )
Other comprehensive loss
Foreign currency translation
(609,695 )
(4,036 )
Comprehensive loss
$ (10,608,522 )
$ (6,875,442 )
Net loss per share - basic and diluted
$ (8.11 )
$ (16.64 )
Weighted average shares outstanding, basic and diluted
1,232,936
413,063
General
and Administrative Expenses
Our
general and administrative expenses decreased to $8,783,619 for the nine months ended September 30, 2022 from $10,864,696 for the
nine months ended September 30, 2021, a decrease of $2,081,077, or 19%. This change was primarily driven by a decrease in stock-based
compensation of $3,532,658, offset by an increase in transaction expenses from equity offerings of $823,970 and an increase in professional
fees of $630,195.
Research
and Development Expenses
Our
research and development expense for the nine months ended September 30, 2022 was $6,134,421 as compared to $2,295,826 for the nine months
ended September 30, 2021 with an increase of $3,838,595, or approximately 167%. This increase was primarily driven by increased product
development activities during the current year, as compared to the prior year, in particular, research relating to psychedelic molecules,
activities which the Company was not engaged in during the comparable quarter of the prior year. In addition, $794,473 of stock-based
compensation expense was allocated to research and development for the nine months ended September 30, 2022, compared to $118,474 for
the nine months ended September 30, 2021.
30
Depreciation
and Amortization Expense
Depreciation and amortization
expense for the nine months ended September 30, 2022 was $241,413 as compared to $484,355 for the nine months ended September 30,
2021, with a decrease of $242,942, or approximately 50%. The decrease in amortization is due to amortization of approximately $396,981
recorded for the Skincare license during the three months ended September 30, 2021. The Skincare license was subsequently fully impaired
in the fourth quarter of 2021, resulting in no amortization of the Skincare license during 2022. This decrease was offset by an increase
in depreciation of $112,610 and an increase in amortization of the Diverse Bio license of $28,125 during the nine months ended September 30,
2022 as compared to the nine months ended September 30, 2021.
Change
in Fair Value of Warrant Liabilities
The
Company’s change in gain in fair value warrant liabilities decreased by $3,231,862 to $3,845,514 for the nine months ended
September 30, 2022 as compared to $7,077,376 for the nine months ended September 30, 2021, primarily due to a change in the
Company’s stock price during the nine months ended September 30, 2022 as compared to the same period in 2021. The Company’s stock
price was $4.22 at September 30, 2022, as compared to $46.50 at December 31, 2021, a decrease of approximately 91% during the nine
months ended September 30, 2022. The Company’s stock price was $103.50 at September 30, 2021, as compared to $74.00 at December 31,
2020, an increase of approximately 40% during the nine months ended September 30, 2021. The significant change in the Company’s
stock price during the nine months ended September 30, 2022 compared to the same period in 2021, resulted in the significant
decrease to the change in fair value of warrant liabilities.
Change
in Fair Value of Investment Option Liability
The
Company’s change in fair value of investment option liability was increased by $1,809,622 for the nine months ended September
30, 2022 as compared to for the nine months ended September 30, 2021, due to the significant decrease in the Company’s stock
price between the issuance of the investment option liability and September 30, 2022. The Company’s stock price was $6.33 on July
26, 2022 (the date of issuance) and $4.22 on September 30, 2022, a decrease of approximately 33% during that time.
Change
in Fair Value of Derivative Liability
The
Company’s change in fair value of derivative liability increased by $284,000 for the nine months ended September 30, 2022 as
compared to for the nine months ended September 30, 2021, due primarily to the announcement of the planned spin-off of Akos.
Inducement
Expense
Inducement
expense was $0 for the nine months ended September 30, 2022 as compared to $298,714 for the nine months ended September 30, 2021, representing
a decrease of 100%. The expenses recorded in 2021 were related to inducement incurred related to the conversion of warrants and options.
The Company did not incur such expenses in the current period.
Foreign
Currency Translation
Our
foreign currency translation loss was $609,695 for the nine months ended September 30, 2022 as compared to a loss of $4,036 for the nine
months ended September 30, 2021, for a change of $605,659. The increase in foreign exchange loss is primarily due to the U.S. Dollar
fluctuating against the Canadian Dollar and the conversion of the Canadian Dollars into United States Dollars for payment of United States
Dollar denominated expenses. In addition, the Company engaged in a significantly higher number of transactions denominated in Canadian
dollars during the nine months ended September 30, 2022, as compared to the nine months ended September 30, 2021, resulting in a much
larger effect of foreign currency translation on the Company’s operations.
Liquidity
and Capital Resources
For the nine months ended
September 30, 2022, the Company had a loss from operations of $15,159,453 and net cash used in operating activities of $13,684,606. As
of September 30, 2022, the Company had an accumulated deficit of $70,529,884. 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.
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 September 30, 2022, the Company had cash of $21,201,005 and working capital of $19,668,572. The Company’s
cash on hand at the filing date is estimated to be sufficient to fund operations, however, there can be no guarantee that the conditions
will not change and that the Company will require additional funding, which may not be available on acceptable terms or at all, in which
case significant delays or cost increases may result in material disruption to the Company’s operations. In such case, the Company
would be required to delay, scale back or eliminate some or all of its research and development programs, which would likely have a material
adverse effect on the Company and its financial statements.
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 sufficient to fund these material cash requirements for the next twelve months.
31
The Company expects to finance
future cash needs through public or private equity offerings, debt financings, or business development transactions. If adequate funds
are not available, the Company may be required to delay, reduce the scope of or eliminate research and development programs or obtain
funds through arrangements with collaborators or others that may require the Company to relinquish rights to certain pipeline candidates
that they might otherwise seek to develop or commercialize independently.
On
February 15, 2022, the Company completed a registered direct offering of 400,000 shares of Common Stock at approximately $25.00 per share
for gross proceeds of approximately $10.0 million. The net proceeds to the Company after deducting financial advisory fees and other
costs and expenses were approximately $9.1 million.
On
July 26, 2022, the Company completed a registered direct offering 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 and unregistered preferred investment options (the
“RD Preferred Investment Options”) to purchase up to 375,000 shares of Common Stock (collectively, the “RD Offering”).
The combined purchase price for one share of Common Stock and associated RD Preferred Investment Option is $8.00. The gross proceeds
from the RD Offering were approximately $3.0 million.
Concurrently
with the RD Offering, the Company completed a registered direct offering 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”). The combined purchase price for one share of Common Stock and associated PIPE Preferred Investment Option is
$8.00. The gross proceeds from the PIPE were approximately $5.0 million. The aggregate net proceeds from the RD Offering and the PIPE,
after deducting the placement agent fees and other estimated offering expenses, were approximately $7.1 million.
We
believe that, as a result of February and July offerings, we currently have sufficient cash and financing commitments to meet our funding
requirements over the next year. Notwithstanding, we expect that we will need to raise additional financing to accomplish our development
plan over the next several years. We may seek to obtain additional funding through debt or equity financing in the future. There are
no assurances that we will be able to raise capital on terms acceptable to us or at all, or that cash flows generated from our operations
will be sufficient to meet our current operating costs. Our ability to obtain additional capital may depend on prevailing economic conditions
and financial, business and other factors beyond our control. The COVID-19 pandemic has caused an unstable economic environment globally.
Disruptions in the global financial markets may adversely impact the availability and cost of credit, as well as our ability to raise
money in the capital markets. Current economic conditions have been and continue to be volatile. Continued instability in these market
conditions may limit our ability to access the capital necessary to fund and grow our business. If we are unable to obtain sufficient
amounts of additional capital, we may be required to reduce the scope of our planned development, which could harm our financial condition
and operating results.
Cash
Flows
Since
inception, we have primarily used our available cash to fund our product development and operations expenditures.
Cash
Flows for the Nine Months Ended September 30, 2022 and 2021
The
following table sets forth a summary of cash flows for the periods presented:
For the Nine Months Ended September 30,
2022
2021
Net cash used in operating activities
$ (13,684,606 )
$ (7,390,358 )
Net cash (used in) provided by investing activities
(577,972 )
2,380,327
Net cash provided by financing activities
18,180,138
24,899,652
Effect of foreign exchange rate on cash
(72,554 )
(19,655 )
Net increase in cash
$ 3,845,006
$ 19,869,966
Operating
Activities
Net
cash used in operating activities was $13,684,606 during the nine months ended September 30, 2022, which consisted primarily of a net
loss of $9,793,431, prepaid expenses of $758,419, change in fair value of warrant liabilities of $3,845,514, and change in fair value
of investment option liability of $1,809,622, offset by stock based compensation of $2,091,299.
32
Net
cash used in operating activities was $7,390,358 during the nine months ended September 30, 2021, which consisted primarily of a net
loss of $6,871,406 and change in fair value of warranty liability of $7,077,376 offset by stock-based compensation of $4,829,484.
Investing
Activities
Net
cash used in investing activities was $577,972 during the nine months ended September 30, 2022, which consisted of the purchase of property
and equipment.
Net
cash provided by investing activities was $2,380,327 during the nine months ended September 30, 2021, which consisted of cash accretive
acquisition of MagicMed of $3,055,327, offset by the acquisition of intellectual property from Diverse Biotech, Inc. of $675,000.
Financing
Activities
Net
cash provided by financing activities was $18,180,138 during the nine months ended September 30, 2022, which consisted of $17,222,100
in net proceeds from the sale of common stock and warrants and proceeds from the sale of redeemable non-controlling interest, net of
offering costs, of $958,038.
Net
cash provided by financing activities was $24,899,652 during the nine months ended September 30, 2021, which consisted of $21,614,488
in net proceeds from the sale of common stock and proceeds from the exercise of warrants of $3,285,164.
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, 2021 and included
in the Annual Report on Form 10-K filed with the SEC on March 31, 2022. 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.
Warrant
Liability and Preferred Investment Options
The
Company accounts for warrants and preferred investment options for shares of the Company’s common stock that are not indexed to
its own stock as liabilities at fair value on the balance sheet. Such warrants and preferred investment options are subject to remeasurement
at each balance sheet date and any change in fair value is recognized as a component of other expense on the statement 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 preferred investment options. At that time, the portion of the liability related to such common stock warrants and
preferred investment options will be reclassified to additional paid-in capital.
Foreign
Currency Risk
The
reporting currency of the Company is the United States dollar, while the functional currency of our subsidiaries, Enveric Biosciences
Canada Inc. and Jay Pharma, Inc., is the Canadian dollar. As a result, the Company is subject to exposure from changes in the exchange
rates of the Canadian dollar and the United States 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 fluctuations in
the future.
Item
3. Quantitative and qualitative disclosures about market risk
From
inception through September 30, 2022, the reporting currency of the Company is the United States dollar while the functional currency
of the Company’s Canadian subsidiaries is the Canadian dollar. As a result, the Company is subject to exposure from changes in
the exchange rates of the Canadian dollar and the U.S. dollar.
33
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 that 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 on Form 10-K for the year ended December 31, 2021, filed on March 31, 2022, continued to exist and were still considered material
weaknesses in our internal control over financial reporting at September 30, 2022.
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 September 30, 2022. 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 September 30, 2022.
Management’s
Remediation Plan
As
previously discussed in our Annual Report on Form 10-K for the year ended December 31, 2021, filed on March 31, 2022, management had
concluded that our internal control over financial reporting was not effective as of December 31, 2021, 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 September 30, 2022, there were control deficiencies which 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 September 30, 2022, that have materially
affected, or are reasonably likely to materially affect, our internal control over financial reporting.
34
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. 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
The
following description of risk factors includes any material changes to, and supersedes the description of, risk factors associated with
our business, financial condition and results of operations previously disclosed in “Item 1A. Risk Factors” of our Annual
Report for the year ended December 31, 2021 on Form 10-K, as filed with the SEC on March 31, 2022. Our business, financial condition
and operating results can be affected by a number of factors, whether currently known or unknown, including but not limited to those
described below, any one or more of which could, directly or indirectly, cause our actual financial condition and operating results to
vary materially from past, or from anticipated future, financial condition and operating results. 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.
Certain
directors who serve on our Board of Directors may also serve as directors of Akos, and ownership of shares of Akos common stock by our
directors and executive officers may create, or appear to create, conflicts of interest.
Certain
of our directors who serve on our Board of Directors may also serve on the board of directors of Akos. This may create, or appear to
create, conflicts of interest when our, or Akos’ management and directors could face decisions that could have different implications
for us and Akos, including the resolution of any dispute regarding the terms of the agreements governing the Spin-Off and the relationship
between us and Akos after the Spin-Off or any other commercial agreements entered into in the future between us and the spun-off business
and the allocation of such directors’ time between us and Akos. The continued or future ownership of such common stock by our directors
and executive officers following the Spin-Off may create the appearance of a conflict of interest when these directors and executive
officers are faced with decisions that could have different implications for us and Akos.
The
Reverse Stock Split may decrease the liquidity of the shares of our common stock.
The
liquidity of the shares of our common stock may be affected adversely by the Reverse Stock Split given the reduced number of shares that
are outstanding following the Reverse Stock Split. In addition, the Reverse Stock Split would have increased the number of stockholders
who own odd lots (less than 100 shares) of our common stock, creating the potential for such stockholders to experience an increase in
the cost of selling their shares and greater difficulty effecting such sales.
35
We
may not meet the continued listing requirements of the Nasdaq Capital Market, which could result in a delisting of our common stock.
Our
common stock is listed on the Nasdaq Capital Market. We have in the past, and may in the future, be unable to comply with certain of
the listing standards that we are required to meet to maintain the listing of our common stock on the Nasdaq Capital Market. For instance,
on February 18, 2022, we received a letter from the Listing Qualifications Department of Nasdaq Stock Market (the “Staff”)
indicating that, based upon the closing bid price of our common stock for the 30 consecutive business day period between January 5, 2022,
through February 17, 2022, we did not meet the minimum bid price of $1.00 per share required for continued listing on the Nasdaq Capital
Market pursuant to Nasdaq Listing Rule 5550(a)(2). On July 29, 2022, we received a letter from the Staff stating that for the last 10
consecutive business days, from July 15 to July 28, 2022, the closing bid price of our common stock had been at $1.00 per share or greater.
Accordingly, the Company has regained compliance with Listing Rule 5550(a)(2).
In
the event that we fail to satisfy any of the listing requirements of the Nasdaq Capital Market, our common stock may be delisted. If
we are unable to list on the Nasdaq Capital Market, it would likely be more difficult to trade in or obtain accurate quotations as to
the market price of our common stock. If our common stock is delisted from trading on the Nasdaq Capital Market, and we are not able
to list our common stock on another exchange or to have it quoted on the Nasdaq Capital Market, our securities could be quoted on the
OTC Bulletin Board or on the “pink sheets.” As a result, we could face significant adverse consequences including, without
limitation,
●
a
limited availability of market quotations for our securities;
●
a
determination that our common stock is a “penny stock” which will require brokers trading in our
common
stock to adhere to more stringent rules and possibly result in a reduced level of trading activity in the secondary trading market for
our securities
●
a
limited amount of news and analyst coverage for our Company; and
●
a
decreased ability to issue additional securities (including pursuant to short-form registration
statements
on Form S-3 or obtain additional financing 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
None.
36
INDEX
TO EXHIBITS
Exhibit
No.
Description
2.1
Share Purchase Agreement, dated January 10, 2020, by and between AMERI Holdings, Inc. and Ameri100, Inc. (incorporated by reference to Exhibit 2.1 to the Company’s Current Report on Form 8-K, filed with the Commission on January 13, 2020)
2.2
Tender Offer Support Agreement and Termination of Amalgamation Agreement, dated August 12, 2020, by and among AMERI Holdings, Inc., Jay Pharma Merger Sub, Inc., Jay Pharma Inc., 1236567 B.C. Unlimited Liability Company and Barry Kostiner, as the Ameri representative (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K, filed with the Commission on August 12, 2020)
2.3
Amendment No. 1 To Tender Offer Support Agreement and Termination of Amalgamation Agreement, dated December 18, 2020, by and among Ameri, Jay Pharma Merger Sub, Inc., Jay Pharma Inc., 1236567 B.C. Unlimited Liability Company and Barry Kostiner, as the Ameri representative (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K, filed with the Commission on December 18, 2020)
2.4
Amalgamation Agreement, dated May 24, 2021, by and among Enveric Biosciences, Inc., 1306432 B.C. LTD., 1306436 B.C. LTD., and MagicMed Industries, Inc. (incorporated by reference to Exhibit 2.1 to the Company’s Current Report on Form 8-K, filed with the Commission on May 24, 2021)
3.1
Amended and Restated Certificate of Incorporation of Enveric Biosciences, Inc. (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K, filed with the Commission on January 6, 2021)
3.2
Certificate of Amendment to Amended and Restated Certificate of Incorporation of Enveric Biosciences, Inc. (incorporated by reference to Exhibit 3.2 to the Company’s Current Report on Form 8-K, filed with the Commission on January 6, 2021)
3.3
Certificate of Designations of Series B Preferred Stock of Enveric Biosciences, Inc. (incorporated by reference to Exhibit 3.3 to the Company’s Current Report on Form 8-K, filed with the Commission on January 6, 2021)
3.4
Amended and Restated Bylaws of Enveric Biosciences, Inc. (incorporated by reference to Exhibit 3.4 to the Company’s Current Report on Form 8-K, filed with the Commission on January 6, 2021)
3.5
Amendment to the Amended and Restated Bylaws of Enveric Biosciences, Inc. (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K, filed with the Commission on November 18, 2021)
3.6
Certificate of Designation of the Series C Preferred Stock of the Company, dated May 4, 2022 (incorporated by reference to Exhibit 3.1 to the Company’s Registration Statement on Form 8-A, filed with the Securities and Exchange Commission on May 4, 2022, File No. 000-26460)
3.7
Certificate of Amendment of Certificate of Designation of the Series C Preferred Stock of the Company, dated May 17, 2022 (incorporated by reference to Exhibit 3.2 to the Company’s Registration Statement on Form 8-A/A, filed with the Securities and Exchange Commission on May 17, 2022, File No. 000 26460)
3.8
Certificate of Amendment of Amended and Restated Certificate of Incorporation of Enveric Biosciences, Inc. (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K, filed with the Commission on July 14, 2022)
4.1
Form of Pre-Funded Warrant (issued in connection with January 2021 Registered Direct Offering) (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K, filed with the Commission on January 12, 2021)
4.2
Form of Warrant (issued in connection with January 2021 Registered Direct Offering) (incorporated by reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K, filed with the Commission on January 12, 2021)
4.3
Form of Warrant (issued in connection with February 2021 Registered Direct Offering) (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K, filed with the Commission on February 11, 2021)
4.4
Form of Series B Warrant (incorporated by reference to Exhibit 4.5 to the Company’s Annual Report on Form 10-K filed with the Commission on April 1, 2021)
4.5
Form of MagicMed Warrant Certificate (incorporated by reference to Exhibit 4.1 of the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on September 17, 2021)
4.6
Form of Common Stock Purchase Warrant (in connection with February 2022 Offering) (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K, filed with the Commission on February 15, 2022)
37
4.7
Form of RD Pre-Funded Warrant (in connection with July 2022 Offering) (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K, filed with the Commission on July 26, 2022)
4.8
Form of PIPE Pre-Funded Warrant (in connection with July 2022 Offering) (incorporated by reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K, filed with the Commission on July 26, 2022)
4.9
Form of RD Preferred Investment Option (in connection with July 2022 Offering) (incorporated by reference to Exhibit 4.3 to the Company’s Current Report on Form 8-K, filed with the Commission on July 26, 2022)
4.10
Form of PIPE Preferred Investment Option (in connection with July 2022 Offering) (incorporated by reference to Exhibit 4.4 to the Company’s Current Report on Form 8-K, filed with the Commission on July 26, 2022)
4.11
Form of Wainwright Warrant (in connection with July 2022 Offering) (incorporated by reference to Exhibit 4.5 to the Company’s Current Report on Form 8-K, filed with the Commission on July 26, 2022)
10.1
First Amendment to the Enveric Biosciences, Inc. 2020 Long-Term Incentive Plan (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K, filed with the Commission on July 14, 2022)#
10.2
Form of Warrant Amendment (in connection with July 2022 Offering) (incorporated by reference to Exhibit 10.4 to the Company’s Current Report on Form 8-K, filed with the Commission on July 26, 2022)
10.3
Form of Securities Purchase Agreement (in connection with July 2022 Offering) (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K, filed with the Commission on July 26, 2022)
10.4
Form of Securities Purchase Agreement (in connection with July 2022 Offering) (incorporated by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K, filed with the Commission on July 26, 2022)
10.5
Form of Registration Rights Agreement (in connection with July 2022 Offering) (incorporated by reference to Exhibit 10.3 to the Company’s Current Report on Form 8-K, filed with the Commission on July 26, 2022)
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
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 (embedded within the Inline XBRL document)
*
Filed
herewith.
**
Furnished
herewith.
#
Management
contract or compensatory plan or arrangement.
38
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
November
14, 2022
By:
/s/
Dr. Joseph Tucker
Dr.
Joseph Tucker
Chief
Executive Officer
(Principal
Executive Officer)
November
14, 2022
By:
/s/
Robert Dickey
Robert
Dickey
Interim
Chief Financial Officer
(Principal
Financial and Accounting Officer)
39
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.