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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:
March 31,
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
May 11, 2022, there were
52,684,548 shares outstanding of Registrant’s Common Stock
(par value $0.01 per share).
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
FORM
10-Q
TABLE
OF CONTENTS
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
See
the accompanying notes to the unaudited condensed consolidated
financial statements.
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
AND COMPREHENSIVE INCOME (LOSS)
See
the accompanying notes to the unaudited condensed consolidated
financial statements.
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN
SHAREHOLDERS’ EQUITY
FOR
THE THREE MONTHS ENDED MARCH 31, 2022 AND 2021
See
the accompanying notes to the unaudited condensed consolidated
financial statements.
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH
FLOWS
See
the accompanying notes to the unaudited condensed consolidated
financial statements.
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
1.
NATURE OF BUSINESS AND
BASIS OF PRESENTATION
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.
At
the effective time of the Amalgamation (the “Effective Time”),
holders of outstanding common shares of MagicMed (the “MagicMed
Shares”) received such number of shares of common stock of the
Company (“Company Shares”) representing, together with the Company
Shares issuable upon exercise of the Warrants and the Converted
Options (each as defined herein), approximately 36.6%
of the issued and outstanding Company Shares (on a fully diluted
basis). The MagicMed Shares were initially converted into Amalco
Redeemable Preferred Shares (as defined in the Amalgamation
Agreement), which immediately following the Amalgamation were
redeemed for 0.000001 of a Company
Share. Following such redemption, the shareholders of MagicMed
received additional Company Shares equal to the product of the
Exchange Ratio (as defined in the Amalgamation Agreement)
multiplied by the number of MagicMed Shares held by each such
shareholder. Additionally, following the Effective Time (i) each
outstanding MagicMed stock option was converted into and became an
option to purchase (the “Converted Options”) the number of Company
Shares equal to the Exchange Ratio multiplied by the number of
MagicMed Shares subject to such MagicMed stock option, and (ii)
each holder of an outstanding MagicMed warrant (including Company
Broker Warrants (as defined in the Amalgamation Agreement), the
“Warrants”) received upon exercise of such Warrant that number of
Company Shares which the holder would have been entitled to receive
as a result of the Amalgamation if, immediately prior to the date
of the Amalgamation (the “Effective Date”), such holder had been
the registered holder of the number of MagicMed Shares to which
such holder would have been entitled if such holder had exercised
such holder’s Warrants immediately prior to the Effective Time (the
foregoing collectively, the “Amalgamation”). In aggregate, holders
of MagicMed Shares received 9,951,217 Company
Shares, representing approximately 31.7% of the
Company Shares following the consummation of the Amalgamation. The
maximum number of Company Shares to be issued by the Company as in
respect of the Warrants and Converted Options shall not exceed
7,404,101 Company
Shares.
The
aggregate number of Company Shares that the Company issued in
connection with the Amalgamation (collectively, the “Share
Consideration”) was in excess of 20% of the
Company’s pre-transaction outstanding Company Shares. Accordingly,
the Company sought and received stockholder approval of the
issuance of the Share Consideration in the Amalgamation in
accordance with the Nasdaq Listing Rules.
Pursuant
to the terms of the Amalgamation Agreement, the Company appointed,
effective as of the Effective Time two individuals selected by
MagicMed to the Company Board of Directors, Dr. Joseph Tucker and
Dr. Brad Thompson.
The
Amalgamation Agreement contained representations and warranties,
closing deliveries and indemnification provisions customary for a
transaction of this nature. The closing of the Amalgamation was
conditioned upon, among other things, (i) the Share Consideration
being approved for listing on Nasdaq, (ii) the effectiveness of a
Registration Statement on Form S-4 registering the Share
Consideration and (iii) the approval (a) of the MagicMed
stockholders of the Amalgamation and (b) of the Company’s
stockholders of each of the Amalgamation and the issuance of the
Share Consideration in the Amalgamation. The closing of the
Amalgamation occurred on September 16, 2021.
MagicMed
Industries develops and commercializes psychedelic-derived
pharmaceutical candidates. MagicMed’s psychedelic derivatives
library, the Psybrary™, is an essential building block from which
industry can develop new patented products. The initial focus of
the Psybrary™ is on psilocybin and DMT derivatives, and it is then
expected to be expanded to other psychedelics.
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
Liquidity and Going Concern and Other
Uncertainties
The
Company has incurred continuing losses from its operations. As of
March 31, 2022, the Company had an accumulated deficit of
$65,260,467 and working capital of
$20,571,914. Since inception, the
Company’s operations have been funded principally through the
issuance of debt and equity.
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. The Company’s
ability to finance future cash needs through equity offerings may
be limited by the amount of authorized and unissued shares. As of
the date of filing of this Quarterly Report on Form 10-Q, the
Company does not have sufficient unreserved, authorized shares to
secure an equity investment of sufficient amount, based on the
Company’s currently traded price per share. The Company intends to
seek shareholder approval for an increase in authorized shares to
remedy the insufficiency of unreserved authorized shares. There can
be no assurances given as to shareholder approval of an increase in
authorized shares.
Nasdaq
Notice
On
February 18, 2022, the Company received a letter from the Listing
Qualifications Department of the Nasdaq 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 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).
In
order to regain compliance with Nasdaq’s minimum bid price
requirement, the Company’s common stock must maintain a minimum
closing bid price of $1.00 for at least ten
consecutive business days during the Compliance Period. In the
event the Company does not regain compliance by the end of the
Compliance Period, the Company may be eligible for additional time
to regain compliance. To qualify, the Company will be required to
meet the continued listing requirement for the market value of its
publicly held shares and all other initial listing standards for
The Nasdaq Capital Market, with the exception of the bid price
requirement, and will need to provide written notice of its
intention to cure the deficiency during the second compliance
period, by effecting a reverse stock split if necessary. If the
Company meets these requirements, the Company may be granted an
additional 180 calendar days to regain compliance. However, if it
appears to Nasdaq that the Company will be unable to cure the
deficiency, or if the Company is not otherwise eligible for the
additional cure period, Nasdaq will provide notice that the
Company’s common stock will be subject to delisting.
While
the letter has no immediate impact on the listing of the Company’s
common stock, which will continue to be listed and traded on The
Nasdaq Capital Market, subject to the Company’s compliance with the
other listing requirements of The Nasdaq Capital Market, a failure
to cure this deficiency would result in a delisting from the
Nasdaq, which would result in significantly increased uncertainty
as to the Company’s ability to raise capital required to fund its
cash requirements.
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 months ended March 31, 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.
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
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
months ended March 31, 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.
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 March 31, 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 March 31, 2022 and March 31, 2021, the
Company engaged in a number of transactions denominated in Canadian
dollars. As a result, the Company is subject to exposure from
changes in the exchange rates of the Canadian dollar and the U.S.
dollar.
The Company translates the assets and liabilities of its Canadian
subsidiaries into the U.S. dollar at the exchange rate in effect on
the balance sheet date. Revenues and expenses are translated at the
average exchange rate in effect during each monthly period.
Unrealized translation gains and losses are recorded as foreign
currency translation gain (loss), which is included in the
consolidated statements of shareholders’ equity as a component of
accumulated other comprehensive income (loss).
The
Company has not entered into any financial derivative instruments
that expose it to material market risk, including any instruments
designed to hedge the impact of foreign currency exposures. The
Company may, however, hedge such exposure to foreign currency
exchange fluctuations in the future.
Adjustments
that arise from exchange rate changes on transactions denominated
in a currency other than the local currency are included in other
comprehensive income (loss) in the consolidated statements of
operations and comprehensive income (loss) as incurred.
Warrant
Liability
The
Company evaluates all of its financial instruments, including
issued stock purchase warrants, 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 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 with put options as liabilities
under ASC 480. Such warrants 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. At that time, the portion of the warrant
liability related to such common stock warrants will be
reclassified to additional paid-in capital.
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.
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
Net Loss per
Share
Basic
net loss per share is computed by dividing net loss by the weighted
average number of shares of common stock outstanding during the
period. Diluted earnings per share is computed using the weighted
average number of common shares and, if dilutive, potential common
shares outstanding during the period. Potential common shares
consist of the incremental common shares issuable upon the exercise
of stock options and warrants (using the treasury stock method).
The computation of basic net loss per share for the three months
ended March 31, 2022 and 2021 excludes potentially dilutive
securities. The computations of net loss per share for each period
presented is the same for both basic and fully diluted. In
accordance with ASC 260-10-45-13, penny warrants were included in
the calculation of weighted average shares outstanding for purposes
of calculating basic and diluted earnings per share.
Potentially
dilutive securities outlined in the table below have been excluded
from the computation of diluted net loss per share for the three
months ended March 31, 2022 and 2021 because the effect of their
inclusion would have been anti-dilutive.
SCHEDULE OF POTENTIALLY DILUTIVE
SECURITIES
|
|
2022 |
|
|
2021 |
|
|
|
For the
Three Months Ended March 31, |
|
|
|
2022 |
|
|
2021 |
|
Warrants to purchase
shares of common stock |
|
|
32,768,766 |
|
|
|
5,979,611 |
|
Restricted stock units
- vested and unissued |
|
|
2,785,820 |
|
|
|
1,207,825 |
|
Restricted stock units
- unvested |
|
|
4,793,102 |
|
|
|
2,071,459 |
|
Restricted stock
awards - vested and unissued |
|
|
42,131 |
|
|
|
44,390 |
|
Restricted stock
awards - unvested |
|
|
6,477 |
|
|
|
26,596 |
|
Options to purchase
shares of common stock |
|
|
1,141,434 |
|
|
|
369,361 |
|
Total potentially
dilutive securities |
|
|
41,537,730 |
|
|
|
9,699,242 |
|
Fair Value
Measurements
Fair
value is defined as the price that would be received to sell an
asset or paid to transfer a liability in an orderly transaction
between market participants at the measurement date. To increase
the comparability of fair value measures, the following hierarchy
prioritizes the inputs to valuation methodologies used to measure
fair value:
Level
1 - Valuations based on quoted prices for identical assets and
liabilities in active markets.
Level
2 - Valuations based on observable inputs other than quoted prices
included in Level 1, such as quoted prices for similar assets and
liabilities in active markets, quoted prices for identical or
similar assets and liabilities in markets that are not active, or
other inputs that are observable or can be corroborated by
observable market data.
Level
3 - Valuations based on unobservable inputs reflecting our own
assumptions, consistent with reasonably available assumptions made
by other market participants. These valuations require significant
judgment.
For
certain financial instruments, including cash, accounts receivable,
and accounts payable, the carrying amounts approximate their fair
values as of March 31, 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 March 31, 2022 and indicates the fair value of the valuation
inputs the Company utilized to determine such fair
value:
SCHEDULE OF FAIR VALUE HIERARCHY OF VALUATION
INPUTS ON RECURRING BASIS
|
|
Level |
|
March 31,
2022 |
|
|
December
31, 2021 |
|
Warrant liabilities -
January 2021 Warrants |
|
3 |
|
$ |
41,201 |
|
|
$ |
333,471 |
|
Warrant liabilities -
February 2021 Warrants |
|
3 |
|
|
41,695 |
|
|
|
320,203 |
|
Warrant liabilities -
February 2022 Warrants |
|
3 |
|
|
3,890,229 |
|
|
|
— |
|
Fair value as of March
31, 2022 |
|
|
|
$ |
3,973,125 |
|
|
$ |
653,674 |
|
Fair value |
|
|
|
$ |
3,973,125 |
|
|
$ |
653,674 |
|
The
warrant liabilities 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.
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
Initial measurement
The
Company established the initial fair value of its warrant
liabilities at the respective dates of issuance. The Company used a
Black Scholes valuation model in order to determine their value.
The key inputs into the Black Scholes valuation model for the
initial valuations are below:
SCHEDULE OF BLACK SCHOLES VALUATION MODELS OF
WARRANT LIABILITIES
|
|
February
2022 Warrants |
|
|
|
February
15, 2022 |
|
Term
(years) |
|
|
5.0 |
|
Stock
price |
|
$ |
0.32 |
|
Exercise
price |
|
$ |
0.55 |
|
Dividend
yield |
|
|
— |
% |
Expected
volatility |
|
|
74.1 |
% |
Risk free interest
rate |
|
|
1.9 |
% |
|
|
|
|
|
Number
of warrants |
|
|
23,000,000 |
|
Value
(per share) |
|
$ |
0.16 |
|
Subsequent
measurement
The
following table presents the changes in fair value of the warrant
liabilities:
SCHEDULE OF FAIR VALUE OF WARRANT
LIABILITIES
|
|
Total
Warrant Liabilities |
|
Fair value as of
December 31, 2021 |
|
$ |
653,674 |
|
Issuance of February
2022 warrants |
|
|
3,595,420 |
|
Change in fair
value |
|
|
(275,969 |
) |
Fair value as of March
31, 2022 |
|
$ |
3,973,125 |
|
The
key inputs into the Black Scholes valuation model for the Level 3
valuations as of March 31, 2022 are below:
SCHEDULE OF BLACK SCHOLES VALUATION MODELS OF
WARRANT LIABILITIES
|
|
January
2021 Warrants |
|
|
February
2021 Warrants |
|
|
February
2022 Warrants |
|
Term
(years) |
|
|
3.8 |
|
|
|
3.9 |
|
|
|
4.9 |
|
Stock
price |
|
$ |
0.33 |
|
|
$ |
0.33 |
|
|
$ |
0.33 |
|
Exercise
price |
|
$ |
4.95 |
|
|
$ |
4.90 |
|
|
$ |
0.55 |
|
Dividend
yield |
|
|
— |
% |
|
|
— |
% |
|
|
— |
% |
Expected
volatility |
|
|
76.0 |
% |
|
|
76.0 |
% |
|
|
75.3 |
% |
Risk free interest
rate |
|
|
2.44 |
% |
|
|
2.44 |
% |
|
|
2.42 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Number
of warrants |
|
|
1,821,449 |
|
|
|
1,714,005 |
|
|
|
23,000,000 |
|
Value
(per share) |
|
$ |
0.02 |
|
|
$ |
0.02 |
|
|
$ |
0.17 |
|
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 March 31, 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.
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
3.
INTANGIBLE ASSETS AND
GOODWILL
As of
March 31, 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 |
|
Gain on
currency translation |
|
|
23,146 |
|
Balance at
March 31, 2022 |
|
$ |
1,610,780 |
|
|
|
|
|
|
Indefinite lived
intangible assets |
|
|
|
|
Balance at December
31, 2021 |
|
$ |
6,375,492 |
|
Gain on
currency translation |
|
|
92,948 |
|
Balance at
March 31, 2022 |
|
$ |
6,468,440 |
|
|
|
|
|
|
Definite lived
intangible assets |
|
|
|
|
Balance at December
31, 2021 |
|
$ |
548,436 |
|
Amortization |
|
|
(42,188 |
) |
Balance at
March 31, 2022 |
|
$ |
506,248 |
|
For
goodwill, identified indefinite lived assets, and identified
definite lived intangible assets, there was no impairment expense
during the three months ended March 31, 2022 and 2021. For
identified definite lived intangible assets, amortization expense
amounted to $42,188
and $136,640
during the three months ended March 31, 2022 and 2021,
respectively.
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 March 31, 2022 is as follows:
SCHEDULE OF FINITE LIVED INTANGIBLE ASSETS
AMORTIZATION EXPENSES
Year
ending December 31, |
|
|
|
2022 (excluding the
three months ended March 31) |
|
$ |
126,563 |
|
2023 |
|
|
168,750 |
|
2024 |
|
|
168,750 |
|
2025 |
|
|
42,185 |
|
Finite
lived Assets Amortization Expense |
|
$ |
506,248 |
|
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
|
|
March 31,
2022 |
|
|
December
31, 2021 |
|
Lab
equipment |
|
$ |
814,555 |
|
|
$ |
310,957 |
|
Computer
equipment |
|
|
16,660 |
|
|
|
10,818 |
|
Property and Equipment, gross |
|
|
|
|
|
|
|
|
Less: Accumulated
depreciation |
|
|
(54,422 |
) |
|
|
(27,345 |
) |
Property
and equipment, net of accumulated depreciation |
|
$ |
776,793 |
|
|
$ |
294,430 |
|
Depreciation
expense was $27,077 and $— for the three
months ended March 31, 2022 and 2021, respectively.
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
5.
SHARE CAPITAL AND
OTHER EQUITY INSTRUMENTS
Authorized Capital
The
holders of the Company’s common stock (“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 March
31, 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 3,275,407 shares of
Series B Preferred Stock converted their shares into 3,275,407 shares of
common stock. Following those conversions, no Series B
Preferred stock shares remain outstanding.
Common Stock Activity
On
February 15, 2022, the Company completed a public offering of
20,000,000 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, Enveric granted
the underwriter a 45-day option to purchase up to an additional
3,000,000 shares of
common stock and/or warrants to purchase up to an additional
3,000,000 shares of common
stock at the public offering price, which the underwriter has
partially exercised for warrants to purchase up to 3,000,000 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.
During
the three months ended March 31, 2022, a total of 44,932
shares of Common Stock were issued pursuant to the conversion of
restricted stock units.
Stock Options
A
summary of activity under the Company’s incentive plan for the
three months ended March 31, 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 |
|
|
1,191,434 |
|
|
$ |
1.58 |
|
|
$ |
2.07 |
|
|
|
5.3 |
|
|
$ |
34,333 |
|
Forfeited |
|
|
(50,000 |
) |
|
|
3.50 |
|
|
|
2.81 |
|
|
|
— |
|
|
|
— |
|
Outstanding at March
31, 2022 |
|
|
1,141,434 |
|
|
$ |
1.50 |
|
|
$ |
2.03 |
|
|
|
4.9 |
|
|
$ |
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at March
31, 2022 |
|
|
958,915 |
|
|
$ |
1.50 |
|
|
$ |
2.01 |
|
|
|
4.2 |
|
|
$ |
— |
|
The
Company’s stock based compensation expense, recorded within general
and administrative expense, related to stock options for the three
months ended March 31, 2022 and 2021 was $36,989
and
$ ,
respectively.
As of March 31, 2022, the Company had $319,895
in
unamortized stock option expense, which will be recognized over a
weighted average period of
1.8 years.
During
the three months ended March 31, 2021, the Company exchanged
options to purchase 560,404 shares of common
stock for 325,410 restricted stock
units and 42,125 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 three months ended March 31, 2022:
SCHEDULE OF RESTRICTED STOCK UNITS AND AWARDS
ACTIVITY
|
|
Number of
shares |
|
|
Weighted
average fair value |
|
Non-vested at December
31, 2021 |
|
|
51,509 |
|
|
$ |
2.83 |
|
Granted |
|
|
1,872,215 |
|
|
$ |
0.67 |
|
Forfeited |
|
|
(35,000 |
) |
|
$ |
2.93 |
|
Vested |
|
|
(10,032 |
) |
|
$ |
3.05 |
|
Non-vested at March
31, 2022 |
|
|
6,477 |
|
|
$ |
1.93 |
|
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
For
the three months ended March 31, 2022 and 2021, the Company
recorded $11,863
and
$32,112,
in stock-based compensation expense within general and
administrative expense, related to restricted stock awards,
respectively. As of March 31, 2022, unamortized stock-based
compensation costs related to restricted share awards was
$12,500,
which will be recognized over a weighted average period of
0.5 years.
The balance of Common Shares related to the vested restricted stock
awards as of March 31, 2022 will be issued during the 2022 calendar
year. There are
42,131 vested
and unissued shares of restricted stock awards as of March 31,
2022.
Issuance of Restricted Stock Units
The
Company’s activity in restricted stock units was as follows for the
three months ended March 31, 2022:
SCHEDULE
OF RESTRICTED STOCK UNITS AND AWARDS
ACTIVITY
|
|
Number of
shares |
|
|
Weighted
average fair value |
|
Non-vested at December
31, 2021 |
|
|
3,100,613 |
|
|
$ |
2.52 |
|
Granted |
|
|
1,872,215 |
|
|
$ |
0.67 |
|
Forfeited |
|
|
(134,794 |
) |
|
$ |
3.99 |
|
Vested |
|
|
(44,932 |
) |
|
$ |
3.99 |
|
Non-vested at March
31, 2022 |
|
|
4,793,102 |
|
|
$ |
1.75 |
|
For
the three months ended March 31, 2022 and 2021, the Company
recorded $719,767 and
$3,559,453,
respectively, in stock-based compensation expense related to
restricted stock units. As of March 31, 2022, the Company had
unamortized stock-based compensation costs related to restricted
stock units of $7,070,834
which will be recognized over a weighted average period of
3.4 years and unamortized
stock-based costs related to restricted stock units. As of March
31, 2022, 44,932
shares of Common Stock have been issued in relation to vested
restricted stock units and 2,785,820
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
|
|
|
|
|
|
|
|
|
Three
months ended March 31, |
|
Stock-based
compensation for RSU |
|
2022 |
|
|
2021 |
|
General and
administrative |
|
$ |
358,818 |
|
|
$ |
3,559,453 |
|
Research and
development |
|
|
360,949 |
|
|
|
— |
|
Total |
|
$ |
719,767 |
|
|
$ |
3,559,453 |
|
Stock-based
compensation |
|
$ |
719,767 |
|
|
$ |
3,559,453 |
|
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, 20,000,000 shares of the
Company’s common stock (“Common Stock”), $0.01 par value per
share, and accompanying warrants to purchase up to an aggregate of
20,000,000 shares of its
common stock (“Warrants”), as well as up to 3,000,000
additional shares of common stock and/or warrants to purchase an
aggregate of up to 3,000,000 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 is being sold together with
a common warrant to purchase one share of common stock, at an
exercise price of $0.55 per share. Such common
warrants are 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 $0.50. On February 14,
2022, the Underwriter exercised its option to purchase an
additional 3,000,000
warrants.
The
following table summarizes information about shares issuable under
warrants outstanding at March 31, 2022:
SCHEDULE OF WARRANTS
|
|
Warrant
shares outstanding |
|
|
Weighted
average exercise price |
|
|
Weighted
average remaining life |
|
|
Intrinsic
value |
|
Outstanding at
December 31, 2021 |
|
|
9,768,766 |
|
|
$ |
2.62 |
|
|
|
3.4 |
|
|
$ |
801,024 |
|
Granted |
|
|
23,000,000 |
|
|
|
0.55 |
|
|
|
— |
|
|
|
— |
|
Outstanding at March
31, 2022 |
|
|
32,768,766 |
|
|
$ |
1.17 |
|
|
|
4.4 |
|
|
$ |
35,729 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at March
31, 2022 |
|
|
32,768,766 |
|
|
$ |
1.17 |
|
|
|
4.4 |
|
|
$ |
35,729 |
|
The
warrants assumed pursuant to the acquisition of MagicMed contain
certain down round features, which were not triggered by the
February 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.
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
6.
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 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 Agreement contains, among
other provisions, representation and warranties, indemnification
obligations and confidentiality provisions in favor of each party
that are customary for an agreement of this nature.
The
Company has met the minimum purchase requirement of 1 kilogram
during the first thirty days of the PureForm Agreement’s
effectiveness.
Purchase agreement with Prof. Zvi Vogel and Dr. Ilana
Nathan
On
December 26, 2017, Jay Pharma entered into a purchase agreement
with Prof. Zvi Vogel and Dr. Ilana Nathan (the “Vogel-Nathan
Purchase Agreement”), pursuant to which Jay Pharma was assigned
ownership rights to certain patents, which were filed and unissued
as of the date of the Vogel-Nathan Purchase Agreement. The
Vogel-Nathan Purchase Agreement includes a commitment to pay a
one-time milestone totaling $200,000 upon
the issuance of a utility patent in the United States or by the
European Patent Office, as defined in the agreement. The Company
has accrued such amount as of December 31, 2021, as a result of the
milestone criteria being achieved. Payment was made during January
2022. In addition, a milestone payment totaling $300,000 is due
upon initiation of a Phase II(b) study. Research activities related
to the relevant patents are still in pre-clinical stage, and
accordingly, this milestone has not been achieved. The Vogel-Nathan
Purchase Agreement contains a commitment for payment of royalties
equaling 2% of the first $20 million in net sales
derived from the commercialization of products utilizing the
relevant patent. As these products are still in the preclinical
phase of development, no royalties have been earned.
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
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, in exchange for
royalty payments of (i) four percent (4.0%) of net sales of OTC
cancer products made via consumer channels; (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.
7.
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 March 31, 2022, the balance
of the deferred tax liability is $1,630,552.
8.
SUBSEQUENT
EVENTS
Spin-Off and Related Private Placement
On May 11, 2022, the Company announced plans to transfer and
spin-off its cannabinoid clinical development pipeline assets to a
wholly-owned subsidiary, Acanna Therapeutics, Inc. (“Acanna”),
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 Acanna meeting the qualifications
for listing on The Nasdaq Stock Market, and if successful, would
result in two standalone public companies.
In connection with the Spin-Off, on May 5, 2022, Acanna and the
Company entered into a Securities Purchase Agreement (the “Purchase
Agreement”) with an accredited investor (the “Investor”), pursuant
to which Acanna agreed to sell up to an aggregate of 5,000 shares of Acanna’s Series
A Convertible Preferred Stock, par value $0.01 per share (the
“Acanna Series A Preferred Stock”), at price of $1,000
per share, and warrants (the “Warrants”) to purchase shares of
Acanna’s common stock, par value $0.01
per share (the “Acanna Common Stock”), for an aggregate purchase
price of up to $5,000,000 (the “Private
Placement”). Pursuant to the Purchase Agreement, Acanna has issued
1,000 shares of the
Acanna Series A Preferred Stock to the Investor in exchange for
$1,000,000 on May
5, 2022, with the remaining Acanna Series A Preferred Stock and
Warrants to be issued for a price of $4,000,000
upon the completion of the Spin-Off (such date that Acanna
commences trading on the Nasdaq Stock Market, the “Spin-Off Date”).
Pursuant the terms of the Purchase Agreement and the Certificate of
the Designations (as defined below), the holders of the Acanna
Series A Preferred Stock have a Put Right (as defined below) under
certain circumstances described below, with Acanna’s payment
obligations under the Put Right guaranteed by the Company. The
Purchase Agreement contains customary representations and
warranties, agreements, obligations, conditions to closing and
termination provisions.
Palladium Capital Advisors, LLC (“Palladium”) acted as placement
agent for the Private Placement. Pursuant to the Purchase
Agreement, Acanna has agreed to pay Palladium a cash fee equal to
9% of the
aggregate gross proceeds raised from the sale of the shares of the
Acanna Series A Preferred Stock and a non-accountable expense
allowance of 1%
of the aggregate gross proceeds raised the sale of the Acanna
Series A Preferred Stock in the Private Placement. In addition,
Acanna will issue to Palladium warrants equal to 8% of
the shares issuable upon conversion of the Acanna Series A
Preferred Stock (the “Palladium Warrants”). The fee due in
connection with the 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 Private Placement (together
with the Palladium Warrants, the “Palladium Securities”).
Terms of Acanna Series A Preferred Stock
Under the Certificate of the Designations, Preferences and Rights
of Series A Convertible Preferred Stock (the “Certificate of
Designations”), on or immediately prior to the Spin-Off Date, the
outstanding Acanna Series A Preferred Stock will be automatically
converted into a number of shares of Acanna Common Stock equal to
25% of
the then issued and outstanding Acanna Common Stock, subject to the
Beneficial Ownership Limitation (as defined below).
The Certificate of Designations contains limitations that prevent
the holder thereof from acquiring shares of Acanna Common Stock
upon conversion that would result in the number of shares of Acanna
Common Stock beneficially owned by such holder and its affiliates
exceeding 9.99% of the total number of
shares of Acanna Common Stock outstanding immediately after giving
effect to the conversion (the “Beneficial Ownership Limitation”),
except that upon notice from the holder to Acanna, the holder may
increase or decrease the amount of ownership of outstanding shares
of Acanna Common Stock after converting the holder’s shares of
Acanna Series A Preferred Stock, provided that any change in the
Beneficial Ownership Limitation shall not be effective until 61
days following notice to Acanna.
The 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 Acanna
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
Acanna Series A Preferred Stock shall have the right (the “Put
Right”), but not the obligation, to cause Acanna to purchase all or
a portion of the Acanna Series A Preferred Stock for a purchase
price equal to $1,000
per share, subject to certain adjustments as set forth in the
Certificate of Designations (the “Stated Value”), plus all the
accrued but unpaid dividends per share. Starting on the execution
date of the Purchase Agreement pursuant to which it is sold, each
share of Acanna Series A Preferred Stock shall accrue cumulative
dividends at the rate of 5% per
annum on the Stated Value, whether or not such dividends are
declared by the Board of Directors and whether or not the
Corporation has the funds available to pay such dividends. These
cumulative dividends will automatically cease accruing on the
Spin-Off Date. In addition, after the one-year anniversary of May
5, 2022, and only in the event that the Spin-Off has not occurred
and Acanna is not in material default of any of the transaction
documents, Acanna may, at its option, at any time and from time to
time, redeem the outstanding shares of Acanna Series A Preferred
Stock, in whole or in part, for a purchase price equal to the
aggregate Stated Value of the shares of Acanna Series A Preferred
Stock being redeemed and the accrued and unpaid dividends on such
shares.
Registration Rights Agreement
In connection with the Private Placement, Acanna entered into a
registration rights agreement, dated as of May 5, 2022 (the
“Registration Rights Agreement”), with the Investor, pursuant to
which Acanna shall, on such date that Acanna files a registration
statement with the SEC in connection with the Spin-Off, file such a
registration statement to register the shares of Acanna Common
Stock issuable upon: (i) the conversion of the Acanna Series A
Preferred Stock sold in the Private Placement, (ii) the exercise of
the Warrants sold in the Private Placement, and (iii) the
conversion or exercise, as applicable, of the Palladium Securities
(the “Registrable Securities”); and to cause such registration
statement to be declared effective under the Securities Act of
1933, as amended (the “Securities Act”), as promptly as possible
after the filing thereof, but in any event no later than the
Spin-Off Date, and shall use its reasonable best efforts to keep
such registration statement continuously effective under the
Securities Act until the date that all Registrable Securities
covered by such registration statement have been sold or are
otherwise able to be sold pursuant to Rule 144 promulgate under the
Securities Act. The Registration Rights Agreement provides for
liquidated damages to the extent that Acanna does not file or
maintain a registration statement in accordance with the terms
thereof.
Series C Preferred Stock
On May 3, 2022, the Board of Directors (the “Board”) declared a
dividend of one one-thousandth of a share of Series C Preferred
Stock (“Series C Preferred Stock”) for each outstanding share of
Common Stock (the “Common Stock”) held of record as of 5:00 p.m.
Eastern Time on May 13, 2022 (the “Record Date”). The outstanding
shares of Series C Preferred Stock will vote together with the
outstanding shares of the Company’s Common Stock, as a single
class, exclusively with respect to a proposal to increase the
number of authorized shares of the Company’s Common Stock, a
proposal giving the Board of Directors 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, as well as any proposal to adjourn any
meeting of stockholders called for the purpose of voting on the
foregoing matters. If these proposals do not receive approval at a
meeting of stockholders duly called for the purpose of voting
thereon, the Company may be unable to regain compliance with
Nasdaq’s minimum bid price requirement within the required period
of time, which could lead to our Common Stock being delisted. If we
are unable to maintain the listing of our Common Stock on Nasdaq,
we may face difficulty raising additional capital.
No
shares of Series C Preferred Stock may be transferred by the holder
thereof except in connection with a transfer by such holder of any
shares of Common Stock held by such holder.
Each share of Series C
Preferred Stock will entitle the holder thereof to 1,000,000 votes
per share (and, for the avoidance of doubt, each fraction of a
share of Series C Preferred Stock will have a ratable number of
votes). Thus, each one-thousandth of a share of Series C Preferred
Stock would entitle the holder thereof to 1,000 votes. The
outstanding shares of Series C Preferred Stock will vote together
with the outstanding shares of Common Stock of the Company as a
single class with respect to certain proposals to amend the
Certificate of Incorporation (“Certificate of Incorporation”) and
to adjourn meetings of stockholders called for the purpose of
voting on Reverse Stock Split (“Reverse Stock Split”) or Share
Increase Proposal (the “Adjournment Proposal”).
The holder of Series C Preferred Stock, as such, will not be
entitled to receive dividends of any kind.
The Series C Preferred Stock will rank senior to the Common Stock
as to any distribution of assets upon a liquidation, dissolution or
winding up of the Company, whether voluntarily or involuntarily (a
“Dissolution”).
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
All shares of Series C Preferred Stock that are not present in
person or by proxy at any meeting of stockholders held to vote on
the Reverse Stock Split, the Share Issuance Proposal and the
Adjournment Proposal as of immediately prior to the opening of the
polls at such meeting (the “Initial Redemption Time”) will
automatically be redeemed in whole, but not in part, by the Company
at the Initial Redemption Time without further action on the part
of the Company or the holder of shares of Series C Preferred Stock
(the “Initial Redemption”).
The Series C Preferred Stock is not convertible into, or
exchangeable for, shares of any other class or series of stock or
other securities of the Company. The Series C Preferred Stock has
no stated maturity and is not subject to any sinking fund. The
Series C Preferred Stock is not subject to any restriction on the
redemption or repurchase of shares by the Company while there is
any arrearage in the payment of dividends or sinking fund
installments.
The Certificate of Designation was filed with the Delaware
Secretary of State and became effective on May 4, 2022.
Departure of Directors or Certain Officers
On May 3, 2022, Brad Thompson, PhD resigned from the board of
directors of the Company. Dr. Thompson’s resignation was not the
result of any disagreement regarding any matter relating to the
Company’s operations, policies, or practices.
Issuance of Shares
In April 2022, the Company issued an aggregate of 61,141 shares of
Common Stock to its Directors, with such shares being the vested
components of restricted stock awards granted to the Company’s
Directors in accordance with the Company’s Director compensation
policies. The shares were issued with legends which restrict their
trading on the Nasdaq exchange .
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;
and |
|
● |
political,
economic, and military instability in Israel which may impede our
development programs. |
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.
Business
Overview
We
are an early-development-stage biosciences company that is
developing innovative, evidence-based prescription products and
combination therapies containing cannabinoids to address unmet
needs in cancer care. 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.
Recent
Developments
February
2022 Offering
On
February 15, 2022, we completed a public offering of 20,000,000
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 3,000,000 shares of common stock and/or warrants to
purchase up to an additional 3,000,000 shares of common stock at
the public offering price, which the underwriter has partially
exercised for warrants to purchase up to 3,000,000 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 Stock
On
May 3, 2022, the Board of Directors declared a dividend of one
one-thousandth of a share of Series C Preferred Stock, par value
$0.01 per share (“Series C Preferred Stock”), for each outstanding
share of Company common stock, par value $0.01 per share (“Common
Stock”), to stockholders of record at 5:00 p.m. Eastern Time on May
13, 2022.
Spin-Off and related Private Placement
On May 11, 2022, the Company announced plans to transfer and
spin-off its cannabinoid clinical development pipeline assets to a
wholly-owned subsidiary, Acanna Therapeutics, Inc. (“Acanna”), by
way of dividend to Enveric shareholders (the “Spin-Off”). The
Spin-Off will be subject to various conditions, including Acanna
meeting the qualifications for listing on The Nasdaq Stock Market,
and if successful, would result in two standalone public
companies.
In connection with the Spin-Off, on May 5, 2022, Acanna and the
Company entered into a securities purchase agreement with an
accredited investor. Under the Securities Purchase Agreement,
Acanna received $1,000,000 in exchange for 1,000 shares of Acanna’s
Series A Convertible Preferred Stock, par value $0.01 per share
(the “Acanna Series A Preferred Stock”). Following the Spin-Off,
Acanna is expected to, subject to certain other conditions, receive
an additional $4,000,000 from the investor in exchange for an
addition 4,000 shares of Acanna Series A Preferred Stock and
warrants to purchase shares of Acanna’s common stock. On or
immediately prior to the Spin-Off, the outstanding Acanna Series A
Preferred Stock will be automatically converted into a number of
shares of Acanna common stock equal to 25% of the then issued and
outstanding Acanna common stock.
In connection with the securities purchase agreement, on May 5,
2022, Acanna entered into a registration rights agreement with the
investor in the securities purchase agreement. Under the
registration rights agreement, Acanna shall on such date that
Acanna files a registration statement with the SEC in connection
with the Spin-Off, file a registration statement to register the
shares of common stock (i) issuable upon conversion of the Acanna
Series A Preferred Stock, (ii) issuable upon exercise of the
warrants to purchase shares of Acanna’s common stock sold in the
private placement (iii) issuable upon exercise of the warrants to
purchase shares of Acanna’s common stock issued to the placement
agent in the private placement, and (iv) issuable upon conversion
of convertible preferred stock issued to the placement agent in the
private placement. Acanna must also to cause such registration
statement to be declared effective under the Securities Act of
1933, as amended (the “Securities Act”), as promptly as possible
after the filing thereof, but in any event no later than the date
of the Spin-Off.
Key
Components of Our Results of Operations
Operating
Expenses
Our
operating expenses include financial statement preparation
services, tax compliance, various consulting and director fees,
legal services, auditing fees, stock-based compensation, and
research and development expenses.
Results
of Operations
The
following table sets forth information comparing the components of
net loss for the three months ended March 31, 2022 and the
comparable period in 2021:
|
|
For the
Three Months Ended March 31, |
|
|
|
2022 |
|
|
2021 |
|
Operating
expenses |
|
|
|
|
|
|
|
|
General
and administrative |
|
$ |
2,767,866 |
|
|
$ |
6,470,405 |
|
Research and
development |
|
|
1,958,714 |
|
|
|
157,952 |
|
Depreciation and
amortization |
|
|
69,265 |
|
|
|
136,640 |
|
Total
operating expenses |
|
|
4,795,845 |
|
|
|
6,764,997 |
|
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
|
(4,795,845 |
) |
|
|
(6,764,997 |
) |
|
|
|
|
|
|
|
|
|
Other income
(expense) |
|
|
|
|
|
|
|
|
Inducement
expense |
|
|
— |
|
|
|
(298,714 |
) |
Change in fair value
of warrant liabilities |
|
|
275,969 |
|
|
|
3,813,000 |
|
Interest
expense |
|
|
(4,138 |
) |
|
|
— |
|
Total
other income |
|
|
271,831 |
|
|
|
3,514,286 |
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
(4,524,014 |
) |
|
|
(3,250,711 |
) |
|
|
|
|
|
|
|
|
|
Other comprehensive
gain |
|
|
|
|
|
|
|
|
Foreign
currency translation |
|
|
88,709 |
|
|
|
35,736 |
|
|
|
|
|
|
|
|
|
|
Comprehensive
loss |
|
$ |
(4,435,305 |
) |
|
$ |
(3,214,975 |
) |
|
|
|
|
|
|
|
|
|
Net loss per share -
basic and diluted |
|
$ |
(0.11 |
) |
|
$ |
(0.20 |
) |
|
|
|
|
|
|
|
|
|
Weighted average
shares outstanding, basic and diluted |
|
|
42,356,752 |
|
|
|
16,220,661 |
|
General
and Administrative Expenses
Our
general and administrative expenses decreased to $2,767,866 for the
three months ended March 31, 2022 from $6,470,405 for the three
months ended March 31, 2021, a decrease of $3,702,539, or 57%. This
change was primarily driven by a decrease in stock-based
compensation of $3,183,895 and a decrease in legal expenses of
$207,894, offset by an increase in salaries and wages of
$282,453.
Research
and Development Expenses
Our
research and development expense for the three months ended March
31, 2022 was $1,958,714 compared to $157,952 for the three months
ended March 31, 2021. 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.
Depreciation
and Amortization Expense
Depreciation
and amortization expense for the three months ended March 31, 2022
was $69,265 as compared to $136,640 for the three months ended
March 31, 2021, with a decrease of $67,375, or approximately 49%.
The decrease is due to amortization expense in the prior year
including charges totaling $136,640 and relating to definite lived
intangible assets which were fully impaired as of December 31,
2021, offset by amortization of $42,188 for definite lived
intangible assets not affected by the prior year impairment and
depreciation expense of $27,077 incurred in relation to fixed
assets acquired subsequent to March 31, 2021.
Change
in Fair Value of Warrant Liabilities
The
Company’s change in gain in fair value warrant liabilities was a
decrease of $3,537,031 for the three months ended March 31, 2022 as
compared to the three months ended March 31, 2021, due primarily to
a decrease in the Company’s stock price within each
period.
Inducement
Expense
Inducement expense was $ for the for the
three months ended March 31, 2022 as compared to $298,714 for the
three months ended March 31, 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 gain (loss) was $88,709 for the three
months ended March 31, 2022 as compared to $35,736 for the three
months ended March 31, 2021, for an increase in $52,973. The
increase in foreign exchange gain is primarily due to the U.S.
Dollar weakening against the Canadian Dollar and the conversion of
the Canadian Dollars into United States Dollars for payment of
United States Dollar denominated expenses.
Liquidity
and Capital Resources
The
Company has incurred continuing losses from its operations. As of
March 31, 2022, the Company has had an accumulated deficit of
$65,260,467 and working capital of $20,571,914. Since inception,
the Company’s operations have been funded principally through the
issuance of debt and equity.
On
February 15, 2022, the Company completed a registered direct
offering of 20,000,000 shares of Common Stock at approximately
$0.50 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.
We
believe that, as a result of February offering, 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.
On
May 3, 2022, the Board of Directors declared a dividend of one
one-thousandth of a share of Series C Preferred Stock for each
outstanding share of Common Stock held of record as of 5:00 p.m.
Eastern Time on May 13, 2022. The outstanding shares of Series C
Preferred Stock will vote together with the outstanding shares of
the Company’s Common Stock, as a single class, exclusively with
respect to a proposal to increase the number of authorized shares
of the Company’s Common Stock, a proposal giving the Board of
Directors 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, as well as any
proposal to adjourn any meeting of stockholders called for the
purpose of voting on the foregoing matters. If these proposals do
not receive approval at a meeting of stockholders duly called for
the purpose of voting thereon, the Company may be unable to regain
compliance with Nasdaq’s minimum bid price requirement within the
required period of time, which could lead to our Common Stock being
delisted. If we are unable to maintain the listing of our Common
Stock on Nasdaq, we may face difficulty raising additional
capital.
Cash
Flows
Since
inception, we have primarily used our available cash to fund our
product development and operations expenditures.
Cash Flows for the Three Months Ended March 31, 2022 and
2021
The
following table sets forth a summary of cash flows for the periods
presented:
|
|
For the
Three Months Ended March 31, |
|
|
|
2022 |
|
|
2021 |
|
Net cash used in
operating activities |
|
$ |
(4,548,941 |
) |
|
$ |
(3,162,278 |
) |
Net cash used in
investing activities |
|
|
(505,507 |
) |
|
|
(675,000 |
) |
Net cash provided by
financing activities |
|
|
9,397,884 |
|
|
|
24,881,733 |
|
Effect of foreign
exchange rate on cash |
|
|
(4,900 |
) |
|
|
34,235 |
|
Net increase in
cash |
|
$ |
4,338,536 |
|
|
$ |
21,078,690 |
|
Operating
Activities
Net
cash used in operating activities was $4,548,941 during the three
months ended March 31, 2022, which consisted primarily of a net
loss of $4,524,014, prepaid expenses of $588,975, and change in
fair value of warrant liabilities of $275,969 offset by stock based
compensation of $768,619.
Net
cash used in operating activities was $3,162,278 during the three
months ended March 31, 2021, which consisted primarily of a net
loss of $3,250,711 and change in fair value of warranty liability
of $3,813,000 offset by stock-based compensation of
$3,591,565.
Investing
Activities
Net
cash used in investing activities was $505,507 during the three
months ended March 31, 2022, which consisted of the purchase of
property and equipment of $505,507.
Net
cash used in investing activities was $675,000 during the three
months ended March 31, 2021, which consisted of the acquisition of
intellectual property from Diverse Bio.
Financing
Activities
Net
cash provided by financing activities was $9,397,884 during the
three months ended March 31, 2022, which consisted of $9,397,884 in
proceeds from the sale of common stock and warrants.
Net
cash provided by financing activities was $24,881,733 during the
three months ended March 31, 2021, which consisted primarily of
$21,614,488 in proceeds from the sale of common stock and proceeds
from the exercise of warrants of $3,267,245.
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
The
Company accounts for warrants 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 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. At that time,
the portion of the warrant liability related to such common stock
warrants 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 March 31, 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.
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
March 31, 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 March 31, 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
March 31, 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
March 31, 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 the first quarter ending March 31, 2022,
that have materially affected, or are reasonably likely to
materially affect, our internal control over financial
reporting.
PART II. OTHER INFORMATION
Item 1. Legal proceedings
The
Company is periodically involved in legal proceedings, legal
actions and claims arising in the ordinary course of business.
Other than as described below, we do not have any pending
litigation that, separately or in the aggregate, would, in the
opinion of management, have a material adverse effect on our
financial position, results of operations or cash flows.
Item 1A. Risk factors
Factors
that could cause our actual results to differ materially from those
in this Quarterly Report are any of the risks described in the
Company’s annual report on Form 10-K as filed with the SEC on March
31, 2022. 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. As of the date of this Quarterly Report,
there have been no material changes to the risk factors disclosed
in the Company’s annual report on Form 10-K as filed with the SEC
on March 31, 2022.
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.
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) |
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) |
10.1 |
|
Form of Securities Purchase Agreement
(entered into in connection with the May 5, 2022 Private Placement)
(incorporated by reference to Exhibit 10.1 to the Company’s Current
Report on Form 8-K, filed with the Commission on May 11,
2022) |
10.2 |
|
Certificate of the Designations,
Preferences and Rights of Acanna Therapeutics, Inc. Series A
Convertible Preferred Stock (incorporated by reference to Exhibit
10.2 to the Company’s Current Report on Form 8-K, filed with the
Commission on May 11, 2022) |
10.3 |
|
Form of Registration Rights Agreement
(entered into in connection with the May 5, 2022 Private Placement)
(incorporated by reference to Exhibit 10.3 to the Company’s Current
Report on Form 8-K, filed with the Commission on May 11,
2022) |
10.4 |
|
Form of Warrant (entered into in
connection with the May 5, 2022 Private Placement) (incorporated by
reference to Exhibit 10.4 to the Company’s Current Report on Form
8-K, filed with the Commission on May 11, 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. |
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 |
May 13,
2022 |
|
|
|
|
|
|
By: |
/s/ Dr. Joseph Tucker |
|
|
Dr. Joseph Tucker |
|
|
Chief Executive
Officer |
|
|
(Principal Executive
Officer) |
|
|
|
May 13, 2022 |
|
|
|
|
|
|
By: |
/s/ Carter J. Ward |
|
|
Carter J. Ward |
|
|
Chief Financial
Officer |
|
|
(Principal Financial and
Accounting Officer) |
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