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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: September 30, 2023
OR
☐
Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
For
the transition period from ___ to ___
Commission
File Number 001-38286
ENVERIC
BIOSCIENCES, INC.
(Exact
name of registrant as specified in its charter)
Delaware |
|
95-4484725 |
(State
or other jurisdiction of
incorporation
or organization) |
|
(IRS
Employer
Identification
No.) |
4851
Tamiami Trail N, Suite 200
Naples,
FL |
|
34103 |
(Address
of principal executive offices) |
|
(Zip
code) |
(239)
302-1707 |
(Registrant’s
telephone number, including area code) |
Securities
registered pursuant to Section 12(b) of the Act:
Title
of Each Class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
Common
Stock, $0.01 par value per share |
|
ENVB |
|
The
Nasdaq Stock Market LLC |
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (Section 232.405 of this chapter) during the preceding 12 months (or such shorter period that the registrant was
required to submit such files). Yes ☒ No ☐
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act:
Large
accelerated filer ☐ |
Accelerated
filer ☐ |
Non-accelerated
filer ☒ |
Smaller
reporting company ☒ |
|
Emerging
growth company ☐ |
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
As
of November 9, 2023, there were 2,321,315 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
| |
September 30, 2023 | | |
December 31, 2022 | |
| |
(unaudited) | | |
| |
ASSETS | |
| | | |
| | |
Current assets: | |
| | | |
| | |
Cash | |
$ | 4,266,568 | | |
$ | 17,723,884 | |
Prepaid expenses and other current assets | |
| 1,560,354 | | |
| 708,053 | |
Total current assets | |
| 5,826,922 | | |
| 18,431,937 | |
| |
| | | |
| | |
Other assets: | |
| | | |
| | |
Property and equipment, net | |
| 539,152 | | |
| 677,485 | |
Right-of-use operating lease asset | |
| — | | |
| 63,817 | |
Intangible assets, net | |
| 253,120 | | |
| 379,686 | |
Total other assets | |
| 792,272 | | |
| 1,120,988 | |
Total assets | |
$ | 6,619,194 | | |
$ | 19,552,925 | |
| |
| | | |
| | |
LIABILITIES, MEZZANINE EQUITY, AND SHAREHOLDERS’ EQUITY | |
| | | |
| | |
Current liabilities: | |
| | | |
| | |
Accounts payable | |
$ | 1,098,233 | | |
$ | 463,275 | |
Accrued liabilities | |
| 1,533,829 | | |
| 1,705,655 | |
Current portion of right-of-use operating lease obligation | |
| — | | |
| 63,820 | |
Investment option liability | |
| 1,250,929 | | |
| 851,008 | |
Warrant liability | |
| 300,557 | | |
| 185,215 | |
Derivative liability | |
| — | | |
| 727,000 | |
Total current liabilities | |
$ | 4,183,548 | | |
$ | 3,995,973 | |
| |
| | | |
| | |
Commitments and contingencies (Note 9) | |
| - | | |
| - | |
| |
| | | |
| | |
Mezzanine equity | |
| | | |
| | |
Series C redeemable preferred stock, $0.01 par value, 100,000 shares authorized, and 0 shares issued and outstanding as of September 30, 2023 and December 31, 2022 | |
| — | | |
| — | |
Redeemable non-controlling interest | |
| — | | |
| 885,028 | |
Total mezzanine equity | |
| — | | |
| 885,028 | |
| |
| | | |
| | |
Shareholders’ equity | |
| | | |
| | |
Preferred stock, $0.01 par value, 20,000,000 shares authorized; Series B preferred stock, $0.01 par value, 3,600,000 shares authorized, 0 shares issued and outstanding as of September 30, 2023 and December 31, 2022 | |
| — | | |
| — | |
Common stock, $0.01 par value, 100,000,000 shares authorized, 2,181,912 and 2,078,271 shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively | |
| 21,818 | | |
| 20,782 | |
Additional paid-in capital | |
| 96,013,029 | | |
| 94,395,662 | |
Accumulated deficit | |
| (93,063,582 | ) | |
| (79,207,786 | ) |
Accumulated other comprehensive loss | |
| (535,619 | ) | |
| (536,734 | ) |
Total shareholders’ equity | |
| 2,435,646 | | |
| 14,671,924 | |
Total liabilities, mezzanine equity, and shareholders’ equity | |
$ | 6,619,194 | | |
$ | 19,552,925 | |
See
the accompanying notes to the unaudited condensed consolidated financial statements.
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
UNAUDITED
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
For the Three Months Ended September 30, | | |
For the Nine Months Ended September 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Operating expenses | |
| | | |
| | | |
| | | |
| | |
General and administrative | |
$ | 2,010,349 | | |
$ | 3,514,547 | | |
$ | 7,921,340 | | |
$ | 8,783,619 | |
Research and development | |
| 1,351,750 | | |
| 2,055,656 | | |
| 5,883,440 | | |
| 6,134,421 | |
Depreciation and amortization | |
| 86,296 | | |
| 86,646 | | |
| 259,300 | | |
| 241,413 | |
Total operating expenses | |
| 3,448,395 | | |
| 5,656,849 | | |
| 14,064,080 | | |
| 15,159,453 | |
| |
| | | |
| | | |
| | | |
| | |
Loss from operations | |
| (3,448,395 | ) | |
| (5,656,849 | ) | |
| (14,064,080 | ) | |
| (15,159,453 | ) |
| |
| | | |
| | | |
| | | |
| | |
Other income (expense) | |
| | | |
| | | |
| | | |
| | |
Change in fair value of warrant liabilities | |
| 67,822 | | |
| 1,599,623 | | |
| (115,342 | ) | |
| 3,845,514 | |
Change in fair value of investment option liability | |
| 562,715 | | |
| 1,809,622 | | |
| (399,921 | ) | |
| 1,809,622 | |
Change in fair value of derivative liability | |
| — | | |
| (231,000 | ) | |
| 727,000 | | |
| (284,000 | ) |
Interest income (expense) | |
| 2,237 | | |
| (308 | ) | |
| 3,142 | | |
| (5,114 | ) |
Total other income | |
| 632,774 | | |
| 3,177,937 | | |
| 214,879 | | |
| 5,366,022 | |
| |
| | | |
| | | |
| | | |
| | |
| |
| | | |
| | | |
| | | |
| | |
Income tax expense | |
| (6,595 | ) | |
| — | | |
| (6,595 | ) | |
| — | |
| |
| | | |
| | | |
| | | |
| | |
Net loss | |
| (2,822,216 | ) | |
| (2,478,912 | ) | |
| (13,855,796 | ) | |
| (9,793,431 | ) |
Less preferred dividends attributable to non-controlling interest | |
| — | | |
| 12,603 | | |
| 19,041 | | |
| 20,411 | |
Less deemed dividends attributable to accretion of embedded derivative at redemption value | |
| — | | |
| 110,991 | | |
| 147,988 | | |
| 184,985 | |
Net loss attributable to shareholders | |
| (2,822,216 | ) | |
| (2,602,506 | ) | |
| (14,022,825 | ) | |
| (9,998,827 | ) |
| |
| | | |
| | | |
| | | |
| | |
Other comprehensive loss | |
| | | |
| | | |
| | | |
| | |
Foreign currency translation | |
| 10,433 | | |
| (417,390 | ) | |
| 1,115 | | |
| (609,695 | ) |
| |
| | | |
| | | |
| | | |
| | |
Comprehensive loss | |
$ | (2,811,783 | ) | |
$ | (3,019,896 | ) | |
$ | (14,021,710 | ) | |
$ | (10,608,522 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net loss per share - basic and diluted | |
$ | (1.30 | ) | |
$ | (1.46 | ) | |
$ | (6.62 | ) | |
$ | (8.11 | ) |
| |
| | | |
| | | |
| | | |
| | |
Weighted average shares outstanding, basic and diluted | |
| 2,164,656 | | |
| 1,787,235 | | |
| 2,117,153 | | |
| 1,232,936 | |
See
the accompanying notes to the unaudited condensed consolidated financial statements.
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
UNAUDITED
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN MEZZANINE EQUITY AND SHAREHOLDERS’ EQUITY
FOR
THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2023 AND 2022
| - |
Shares | | |
Amount | | |
Equity | | |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Loss | | |
Equity | |
| |
Redeemable
Non-controlling Interest | | |
Total Mezzanine | | |
Common
Stock | | |
Additional Paid-In | | |
Accumulated | | |
Accumulated Other Comprehensive | | |
Total
Shareholders’ | |
| |
Shares | | |
Amount | | |
Equity | | |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Loss | | |
Equity | |
Balance at January 1, 2023 | - |
| 1,000 | | |
$ | 885,028 | | |
$ | 885,028 | | |
| 2,078,271 | | |
$ | 20,782 | | |
$ | 94,395,662 | | |
$ | (79,207,786 | ) | |
$ | (536,734 | ) | |
$ | 14,671,924 | |
Stock-based compensation | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| 532,835 | | |
| — | | |
| — | | |
| 532,835 | |
Preferred dividends attributable to redeemable non-controlling
interest | |
| — | | |
| 12,329 | | |
| 12,329 | | |
| — | | |
| — | | |
| (12,329 | ) | |
| — | | |
| — | | |
| (12,329 | ) |
Accretion of embedded derivative to redemption value | |
| — | | |
| 110,991 | | |
| 110,991 | | |
| — | | |
| — | | |
| (110,991 | ) | |
| — | | |
| — | | |
| (110,991 | ) |
Foreign exchange translation gain | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| 1,968 | | |
| 1,968 | |
Net loss | - |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| (4,677,527 | ) | |
| — | | |
| (4,677,527 | ) |
Balance at March 31, 2023 | - |
| 1,000 | | |
$ | 1,008,348 | | |
$ | 1,008,348 | | |
| 2,078,271 | | |
$ | 20,782 | | |
$ | 94,805,177 | | |
$ | (83,885,313 | ) | |
$ | (534,766 | ) | |
$ | 10,405,880 | |
Stock-based compensation | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| 879,738 | | |
| — | | |
| — | | |
| 879,738 | |
Preferred dividends attributable to redeemable non-controlling interest | |
| — | | |
| 6,712 | | |
| 6,712 | | |
| — | | |
| — | | |
| (6,712 | ) | |
| — | | |
| — | | |
| (6,712 | ) |
Accretion of embedded derivative to redemption value | |
| — | | |
| 36,997 | | |
| 36,997 | | |
| — | | |
| — | | |
| (36,997 | ) | |
| — | | |
| — | | |
| (36,997 | ) |
Redemption of Series A preferred stock | |
| (1,000 | ) | |
| (1,052,057 | ) | |
| (1,052,057 | ) | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | |
Issuance of common shares in exchange for RSU conversions
from the reduction in force | |
| — | | |
| — | | |
| — | | |
| 63,511 | | |
| 635 | | |
| (635 | ) | |
| — | | |
| — | | |
| — | |
Foreign exchange translation loss | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| (11,286 | ) | |
| (11,286 | ) |
Net loss | - |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| (6,356,053 | ) | |
| — | | |
| (6,356,053 | ) |
Balance at June 30, 2023 | - |
| — | | |
$ | — | | |
$ | — | | |
| 2,141,782 | | |
$ | 21,417 | | |
$ | 95,640,571 | | |
$ | (90,241,366 | ) | |
$ | (546,052 | ) | |
$ | 4,874,570 | |
Stock-based compensation | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| 372,859 | | |
| — | | |
| — | | |
| 372,859 | |
Issuance of common shares in exchange for RSU conversions | |
| — | | |
| — | | |
| — | | |
| 40,130 | | |
| 401 | | |
| (401 | ) | |
| — | | |
| — | | |
| — | |
Foreign exchange translation loss | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| 10,433 | | |
| 10,433 | |
Net loss | - |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| (2,822,216 | ) | |
| — | | |
| (2,822,216 | ) |
Balance at September 30, 2023 | - |
| — | | |
$ | — | | |
$ | — | | |
| 2,181,912 | | |
$ | 21,818 | | |
$ | 96,013,029 | | |
$ | (93,063,582 | ) | |
$ | (535,619 | ) | |
$ | 2,435,646 | |
See
the accompanying notes to the unaudited condensed consolidated financial statements.
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
UNAUDITED
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN MEZZANINE EQUITY AND SHAREHOLDERS’ EQUITY
FOR
THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2023 AND 2022
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Equity | | |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Income
(Loss) | | |
Equity | |
| |
Series
C Preferred Stock | | |
Redeemable
Non-controlling Interest | | |
Total Mezzanine | | |
Common
Stock | | |
Additional Paid-In | | |
Accumulated | | |
Accumulated
Other Comprehensive | | |
Total Shareholders’ | |
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Equity | | |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Income (Loss) | | |
Equity | |
Balance at January 1, 2022 | |
| — | | |
$ | — | | |
| — | | |
$ | — | | |
| — | | |
| 651,921 | | |
$ | 6,519 | | |
$ | 83,066,656 | | |
$ | (60,736,453 | ) | |
$ | (30,802 | ) | |
$ | 22,305,920 | |
February 2022 registered direct offering | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| 400,000 | | |
| 4,000 | | |
| 5,798,464 | | |
| — | | |
| — | | |
| 5,802,464 | |
Stock-based compensation | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| 768,619 | | |
| — | | |
| — | | |
| 768,619 | |
Conversion of RSUs into common shares | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| 899 | | |
| 9 | | |
| (9 | ) | |
| — | | |
| — | | |
| — | |
Foreign exchange translation gain | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| 88,709 | | |
| 88,709 | |
Net loss | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| (4,524,014 | ) | |
| — | | |
| (4,524,014 | ) |
Balance at March 31, 2022 | |
| — | | |
$ | — | | |
| — | | |
$ | — | | |
$ | — | | |
| 1,052,820 | | |
$ | 10,528 | | |
$ | 89,633,730 | | |
$ | (65,260,467 | ) | |
$ | 57,907 | | |
$ | 24,441,698 | |
Stock-based compensation | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| 677,543 | | |
| — | | |
| — | | |
| 677,543 | |
Redeemable non-controlling interest, net of $402,000 embedded derivative and net of issuance costs of $41,962 | |
| — | | |
| — | | |
| 1,000 | | |
| 556,038 | | |
| 556,038 | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | |
Issuance of redeemable non-controlling Series C preferred stock | |
| 52,685 | | |
| 527 | | |
| — | | |
| — | | |
| 527 | | |
| — | | |
| — | | |
| (527 | ) | |
| — | | |
| — | | |
| (527 | ) |
Preferred dividends attributable to redeemable non-controlling
interest | |
| — | | |
| — | | |
| — | | |
| 7,808 | | |
| 7,808 | | |
| — | | |
| — | | |
| (7,808 | ) | |
| — | | |
| — | | |
| (7,808 | ) |
Accretion of embedded derivative to redemption value | |
| — | | |
| — | | |
| — | | |
| 73,994 | | |
| 73,994 | | |
| — | | |
| — | | |
| (73,994 | ) | |
| — | | |
| — | | |
| (73,994 | ) |
Conversion of RSAs into common shares | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| 1,223 | | |
| 12 | | |
| (12 | ) | |
| — | | |
| — | | |
| — | |
Foreign exchange translation gain | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| (281,014 | ) | |
| (281,014 | ) |
Net loss | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| (2,790,505 | ) | |
| — | | |
| (2,790,505 | ) |
Balance at June 30, 2022 | |
| 52,685 | | |
$ | 527 | | |
| 1,000 | | |
$ | 637,840 | | |
$ | 638,367 | | |
| 1,054,043 | | |
$ | 10,540 | | |
$ | 90,228,932 | | |
$ | (68,050,972 | ) | |
$ | (223,107 | ) | |
$ | 21,965,393 | |
Balance | |
| 52,685 | | |
$ | 527 | | |
| 1,000 | | |
$ | 637,840 | | |
$ | 638,367 | | |
| 1,054,043 | | |
$ | 10,540 | | |
$ | 90,228,932 | | |
$ | (68,050,972 | ) | |
$ | (223,107 | ) | |
$ | 21,965,393 | |
Stock-based compensation | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| 645,137 | | |
| — | | |
| — | | |
| 645,137 | |
July 2022 registered direct offering, PIPE offering, modification of warrants and exercise of pre-funded warrants, net of offering costs | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| 1,000,000 | | |
| 10,000 | | |
| 3,239,125 | | |
| — | | |
| — | | |
| 3,249,125 | |
Issuance of rounded shares as a result of the reverse stock split | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| 24,228 | | |
| 242 | | |
| (242 | ) | |
| — | | |
| — | | |
| — | |
Preferred dividends attributable to redeemable non-controlling interest | |
| — | | |
| — | | |
| — | | |
| 12,603 | | |
| 12,603 | | |
| — | | |
| — | | |
| (12,603 | ) | |
| — | | |
| — | | |
| (12,603 | ) |
Accretion of embedded derivatives to redemption value | |
| — | | |
| — | | |
| — | | |
| 110,991 | | |
| 110,991 | | |
| — | | |
| — | | |
| (110,991 | ) | |
| — | | |
| — | | |
| (110,991 | ) |
Redemption of Series C preferred stock | |
| (52,685 | ) | |
| (527 | ) | |
| — | | |
| — | | |
| (527 | ) | |
| — | | |
| — | | |
| 527 | | |
| — | | |
| — | | |
| 527 | |
Foreign exchange translation loss | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| (417,390 | ) | |
| (417,390 | ) |
Net loss | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| (2,478,912 | ) | |
| — | | |
| (2,478,912 | ) |
Balance at September 30, 2022 | |
| — | | |
$ | — | | |
| 1,000 | | |
$ | 761,434 | | |
$ | 761,434 | | |
| 2,078,271 | | |
$ | 20,782 | | |
$ | 93,989,885 | | |
$ | (70,529,884 | ) | |
$ | (640,497 | ) | |
$ | 22,840,286 | |
Balance | |
| — | | |
$ | — | | |
| 1,000 | | |
$ | 761,434 | | |
$ | 761,434 | | |
| 2,078,271 | | |
$ | 20,782 | | |
$ | 93,989,885 | | |
$ | (70,529,884 | ) | |
$ | (640,497 | ) | |
$ | 22,840,286 | |
See
the accompanying notes to the unaudited condensed consolidated financial statements.
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
UNAUDITED
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
| |
2023 | | |
2022 | |
| |
For the Nine Months Ended | |
| |
2023 | | |
2022 | |
Cash Flows From Operating Activities: | |
| | | |
| | |
Net loss | |
$ | (13,855,796 | ) | |
$ | (9,793,431 | ) |
Adjustments to reconcile net loss to cash used in operating activities | |
| | | |
| | |
Change in fair value of warrant liability | |
| 115,342 | | |
| (3,845,514 | ) |
Change in fair value of investment option liability | |
| 399,921 | | |
| (1,809,622 | ) |
Change in fair value of derivative liability | |
| (727,000 | ) | |
| 284,000 | |
Stock-based compensation | |
| 1,785,432 | | |
| 2,091,299 | |
Amortization of right-of-use asset | |
| 64,246 | | |
| 103,365 | |
Amortization of intangible assets | |
| 126,566 | | |
| 126,563 | |
Depreciation expense | |
| 132,734 | | |
| 114,850 | |
Gain on disposal of property and equipment | |
| (4,219 | ) | |
| — | |
Change in operating assets and liabilities: | |
| | | |
| | |
Prepaid expenses and other current assets | |
| (746,033 | ) | |
| (758,419 | ) |
Accounts payable and accrued liabilities | |
| 429,688 | | |
| (106,675 | ) |
Right-of-use operating lease liability | |
| (64,244 | ) | |
| (91,022 | ) |
Net cash used in operating activities | |
| (12,343,363 | ) | |
| (13,684,606 | ) |
| |
| | | |
| | |
Cash Flows From Investing Activities: | |
| | | |
| | |
Purchases of property and equipment | |
| (5,195 | ) | |
| (577,972 | ) |
Proceeds from disposal of property and equipment | |
| 16,900 | | |
| — | |
Net cash provided by (used in) investing activities | |
| 11,705 | | |
| (577,972 | ) |
| |
| | | |
| | |
Cash Flows From Financing Activities: | |
| | | |
| | |
Payment for the deferred offering costs from the equity distribution agreement | |
| (105,000 | ) | |
| — | |
Proceeds from sale of common stock, warrants, and investment options, net of offering costs | |
| — | | |
| 17,222,100 | |
Redemption of Series A Preferred Stock (see Note 8) | |
| (1,052,057 | ) | |
| — | |
Proceeds from the sale of redeemable non-controlling interest, net of offering | |
| — | | |
| 958,038 | |
Net cash (used in) provided by financing activities | |
| (1,157,057 | ) | |
| 18,180,138 | |
| |
| | | |
| | |
Effect of foreign exchange rate on cash | |
| 31,399 | | |
| (72,554 | ) |
| |
| | | |
| | |
Net (decrease) increase in cash | |
| (13,457,316 | ) | |
| 3,845,006 | |
Cash at beginning of period | |
| 17,723,884 | | |
| 17,355,999 | |
Cash at end of period | |
$ | 4,266,568 | | |
$ | 21,201,005 | |
| |
| | | |
| | |
Supplemental disclosure of cash and non-cash transactions: | |
| | | |
| | |
Cash paid for interest | |
$ | — | | |
$ | 5,114 | |
Income taxes paid | |
$ | 6,595 | | |
$ | — | |
Warrants issued in conjunction with common stock issuance | |
$ | — | | |
$ | 3,595,420 | |
Issuance of embedded derivative | |
$ | — | | |
$ | 402,000 | |
Issuance of redeemable non-controlling Series C preferred stock | |
$ | — | | |
$ | — | |
Offering costs accrued not paid | |
$ | 20,800 | | |
$ | — | |
Preferred dividends attributable to redeemable non-controlling interest | |
$ | 19,041 | | |
$ | 20,411 | |
Accretion of embedded derivative to redemption value | |
$ | 147,988 | | |
$ | 184,985 | |
Investment options issued in conjunction with common stock issuance | |
$ | — | | |
$ | 4,323,734 | |
Modification of warrants as part of share capital raise | |
$ | — | | |
$ | 251,357 | |
See
the accompanying notes to the unaudited condensed consolidated financial statements.
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
NOTE
1. BUSINESS AND LIQUIDITY AND OTHER UNCERTAINTIES
Nature
of Operations
Enveric
Biosciences, Inc. (“Enveric” or the “Company”) is a biotechnology company developing novel neuroplastogenic small-molecule
therapeutics for the treatment of depression, anxiety, and addiction disorders. The head office of the Company is located in Naples,
Florida. The Company has the following wholly-owned subsidiaries: Jay Pharma Inc. (“Jay Pharma”), 1306432 B.C. Ltd. (“HoldCo”),
MagicMed Industries, Inc. (“MagicMed”), Enveric Canada Inc., and Enveric Therapeutics, Pty. Ltd. (“Enveric Therapeutics”).
Leveraging
its unique discovery and development platform, The Psybrary™, Enveric has created a robust Intellectual Property portfolio of New
Chemical Entities for specific mental health indications. Enveric’s lead program, the EVM201 Series, comprises next generation
synthetic prodrugs of the active metabolite, psilocin. Enveric is developing the first product from the EVM201 Series – EB-373
– for the treatment of psychiatric disorders. Enveric is also advancing its second program, the EVM301 Series, expected to offer
a first-in-class, new approach to the treatment of difficult-to-address mental health disorders, mediated by the promotion of neuroplasticity
without also inducing hallucinations in the patient.
Following
the Company’s amalgamation with MagicMed completed in September 2021 (the “Amalgamation”), the Company has continued
to pursue the development of MagicMed’s proprietary Psychedelic Derivatives library, the Psybrary™ which the Company believes
will help to identify and develop the right drug candidates needed to address mental health challenges, including cancer-related distress.
The Company synthesizes novel versions of classic psychedelics, such as psilocybin, DMT, mescaline and MDMA, using a mixture of chemistry
and synthetic biology, resulting in the expansion of the Psybrary™, which includes 15 patent families with over a million potential
variations and hundreds of synthesized molecules. Within the Psybrary™ the Company has three different types of molecules, Generation
1 (classic psychedelics), Generation 2 (pro-drugs), and Generation 3 (new chemical entities). The Company is working to add novel psychedelic
molecular compounds and derivatives (“Psychedelic Derivatives”) on a regular basis through its work at the Company’s
labs in Calgary, Alberta, Canada, where the Company has a team of PhD scientists with expertise in synthetic biology and chemistry. To
date the Company has created over 500 molecules that are housed in the Psybrary™.
The
Company screens newly synthesized molecules in the Psybrary™ through PsyAI™, a proprietary artificial intelligence (“AI”)
tool. Leveraging AI systems is expected to reduce the time and cost of pre-clinical, clinical, and commercial development. The Company
believes it streamlines pharmaceutical design by predicting ideal binding structures of molecules, manufacturing capabilities, and pharmacological
effects to help determine ideal drug candidates, tailored to each indication. Each of these molecules that the Company believes are patentable
can then be further screened to see how changes to its makeup alter its effects in order to synthesize additional new molecules. New
compounds of sufficient purity are undergoing pharmacological screening, including non-clinical (receptors/cell lines), preclinical (animal),
and ultimately clinical (human) evaluations. The Company intends to utilize the Psybrary™ and the AI tool to categorize and characterize
the Psybrary™ substituents to focus on bringing more psychedelics-inspired molecules from discovery to the clinical phase.
Akos
Spin-Off
On
May 11, 2022, the Company announced plans to transfer and spin-off its cannabinoid clinical development pipeline assets to Akos Biosciences,
Inc. (formerly known as Acanna Therapeutics, Inc.), a majority-owned subsidiary of the Company (hereafter referred to as “Akos”),
which was incorporated on April 13, 2022, by way of dividend to Enveric shareholders (the “Spin-Off”). As of May 12, 2023,
the holders of the Company’s Akos Series A Preferred Stock, par value $0.01 per share (“Akos Series A Preferred Stock”)
have exercised this right to force redemption of all of the Akos Series A Preferred Stock for $1,000 per share, plus accrued but unpaid
dividends of $52,057 for a total of $1,052,057. The Company made full payment on May 19, 2023. See Note 8.
Australian
Subsidiary
On
March 21, 2023, the Company established Enveric Therapeutics, an Australia-based subsidiary, to support the Company’s plans to
advance its lead program, the EVM201 Series, comprised of the next generation synthetic prodrugs of the active metabolite, psilocin (“EVM201
Series”), towards the clinic. Enveric Therapeutics will oversee the Company’s preclinical, clinical, and regulatory activities
in Australia, including ongoing interactions with the local Human Research Ethics Committees (HREC) and the Therapeutic Goods Administration
(TGA), Australia’s regulatory authority.
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Going
Concern, Liquidity and Other Uncertainties
The
Company has incurred a loss since inception resulting in an accumulated deficit of $93,063,582 as of September 30, 2023, and further
losses are anticipated in the development of its business. Further, the Company had operating cash outflows of $12,343,363 for the nine
months ended September 30, 2023. For the nine months ended September 30, 2023, the Company had a loss from operations of $14,064,080.
Since its inception, being a research and development company, the Company has not yet generated revenue and the Company has incurred
continuing losses from its operations. The Company’s operations have been funded principally through the issuance of debt and equity.
These factors raise substantial doubt about the Company’s ability to continue as a going concern for a period of one year from
the issuance of these financial statements.
In
assessing the Company’s ability to continue as a going concern, the Company monitors and analyzes its cash and its ability to generate
sufficient cash flow in the future to support its operating and capital expenditure commitments. At September 30, 2023, the Company had
cash of $4,266,568 and working capital of $1,643,374. The Company’s current cash on hand is insufficient to satisfy its operating
cash needs for the 12 months following the filing of this Quarterly Report on Form 10-Q. These conditions raise substantial doubt regarding
the Company’s ability to continue as a going concern for a period of one year after the date the financial statements are issued.
Management’s plan to alleviate the conditions that raise substantial doubt include reducing the Company’s rate of spend,
managing its cash flow, advancing its programs, and raising additional working capital through public or private equity or debt financings
or other sources, which has included the Equity Distribution Agreement with Canaccord for proceeds of up to $2.4 million (see Note 7) and the Purchase Agreement with Lincoln Park (see Note 10), subject to registration, and may include collaborations
with additional third parties, as well as disciplined cash spending, to increase the Company’s cash runway. Adequate additional
financing may not be available to the Company on acceptable terms, or at all. Should the Company be unable to raise sufficient additional
capital, the Company may be required to undertake cost-cutting measures including delaying or discontinuing certain operating activities.
The
Company’s material cash requirements consist of working capital to fund capital expenditures incurred at their research facility
in Calgary and their operations, which consist primarily of, without limitation, employee related expenses, product development activities
conducted by third parties, research materials and lab supplies, facility related expenses including rent and maintenance, costs associated
with preclinical studies, patent related costs, costs of regulatory and public company compliance, insurance costs, audit costs, consultants
and legal fees. Additionally, the Company currently utilizes third-party contract research organizations (“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 manufacturing organizations (“CMOs”) to carry out their clinical
manufacturing activities as it does not yet have a commercialization infrastructure, and incur significant expenses related to developing
its internal commercialization capability to support product sales, marketing and distribution. The Company’s current working capital
resources are insufficient to fund these material cash requirements for the next twelve months.
As
a result of these factors, management has concluded that there is substantial doubt about the Company’s ability to continue as
a going concern for a period of one year after the date of the financial statements are issued. The Company’s unaudited condensed
consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Reduction
in Force/Restructuring
In
May 2023, the Company entered into a cost reduction plan, including a reduction in force of approximately 35% of its full-time employees
to streamline its operations and conserve cash resources. Additionally, contracts with seven consultants that were focused on the Akos
cannabinoid spin-out were terminated. The Company recognized severance charges of approximately $453,059 through September 30, 2023.
The plan included a focus on progressing the Company’s existing non-cannabinoid pipeline while reducing the rate of spend and managing
cash flow. In June 2023, the Company completed the reduction in force, with such severance expenses recorded in general and administrative
accounts.
On
June 16, 2023, the Company entered into a separation agreement with Avani Kanubaddi, the Company’s President and Chief Operating
Officer (the “Kanubaddi Separation Agreement”). In accordance with the Kanubaddi Separation Agreement, Mr. Kanubaddi’s
outstanding restricted stock units (“RSUs”) will retain their vesting conditions. Mr. Kanubaddi’s 2023 salary and benefits
of $550,974 were accrued and will be paid out in twelve equal monthly installments beginning in July 2023. Upon termination, any unvested
time-based RSUs became fully vested. The Company accelerated expense recognized related to these shares that vested was $231,273. Of
the 11,278 market performance-based RSUs previously granted, 3,759 will continue to be subject to the original terms and conditions of
Mr. Kanubaddi’s employment agreement and the remainder were forfeited.
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
SCHEDULE
OF RESTRUCTURING COSTS PAYABLE
| |
Accrued Restructuring Costs | |
January 1, 2023 Beginning balance | |
$ | — | |
Restructuring costs incurred | |
| 1,004,033 | |
Restructuring costs paid | |
| (396,431 | ) |
September 30, 2023 ending balance | |
$ | 607,602 | |
Inflation
Risks
The
Company considers the current inflationary trend existing in the North American economic environment reasonably likely to have a material
unfavorable impact on results of continuing operations. Higher rates of price inflation, as compared to recent prior levels of price
inflation, have caused a general increase in the cost of labor and materials. In addition, there is an increased risk of the Company
experiencing labor shortages due to a potential inability to attract and retain human resources due to increased labor costs resulting
from the current inflationary environment.
NOTE
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis
of Presentation and Principal of Consolidation
The
accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally
accepted in the United States (“U.S. GAAP”) for interim financial information and Article 8 of Regulation S-X. Accordingly,
they do not include all the information and footnotes required by U.S. GAAP for complete financial statements. Management’s opinion
is that all adjustments (consisting of normal accruals) considered necessary for a fair presentation have been included. Operating results
for the three and nine months ended September 30, 2023 are not necessarily indicative of the results that may be expected for the year
ending December 31, 2023. These unaudited condensed consolidated financial statements should be read in conjunction with the consolidated
financial statements for the year ended December 31, 2022, and related notes thereto included in the Company’s Annual Report on
Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on March 31, 2023 and subsequently amended on Form
10-K/A Amendment No. 1 filed with the SEC on June 9, 2023 (as amended, the “Annual Report”).
The
Company’s significant accounting policies and recent accounting standards are summarized in Note 2 of the Company’s consolidated
financial statements for the year ended December 31, 2022. There were no significant changes to these accounting policies during the
three and nine months ended September 30, 2023.
Use
of Estimates
The
preparation of the unaudited condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates
and assumptions that affect the reported amount of assets and liabilities at the date of the financial statements and expenses during
the periods reported. By their nature, these estimates are subject to measurement uncertainty and the effects on the financial statements
of changes in such estimates in future periods could be significant. Significant areas requiring management’s estimates and assumptions
include determining the fair value of transactions involving common stock and the valuation of stock-based compensation, accruals associated
with third party providers supporting research and development efforts, and estimated fair values of long lived assets used to record
impairment charges related to intangible assets. Actual results could differ from those estimates.
Foreign
Currency Translation
From
inception through September 30, 2023, the reporting currency of the Company was the United States dollar while the functional currency
of certain of the Company’s subsidiaries was the Canadian dollar and Australian dollar. For the reporting periods ended September
30, 2023 and 2022, the Company engaged in a number of transactions denominated in Canadian dollars and Australian dollars. As a result,
the Company is subject to exposure from changes in the exchange rates of the Canadian dollar and Australian dollar against the United
States dollar.
The
Company translates the assets and liabilities of its Canadian subsidiaries and Australian subsidiary into the United States dollar at
the exchange rate in effect on the balance sheet date. Revenues and expenses are translated at the average exchange rate in effect during
each monthly period. Unrealized translation gains and losses are recorded as foreign currency translation gain (loss), which is included
in the condensed consolidated statements of shareholders’ equity as a component of accumulated other comprehensive loss.
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
The
Company has not entered into any financial derivative instruments that expose it to material market risk, including any instruments designed
to hedge the impact of foreign currency exposures. The Company may, however, hedge such exposure to foreign currency exchange fluctuations
in the future.
Adjustments
that arise from exchange rate changes on transactions denominated in a currency other than the local currency are included in other comprehensive
loss in the condensed consolidated statements of operations and comprehensive loss as incurred.
Concentration
of Credit Risk
Financial
instruments that potentially subject the Company to concentrations of credit risk consist of cash accounts in a financial institution,
which at times, may exceed the federal depository insurance coverage of $250,000 in the United States and Australia and $100,000 in Canada.
The Company has not experienced losses on these accounts, and management believes the Company is not exposed to significant risks on
such accounts. As of September 30, 2023, the Company had greater than $250,000 at United States financial institutions, less than $250,000
at Australian financial institutions, and greater than $100,000 at Canadian financial institutions.
Deferred
Offering Costs
The
Company complies with the requirements of ASC Topic 340, Other Assets and Deferred Costs (“ASC 340”) and SAB 5A -
Expenses of Offering. Offering costs, which consist mainly of legal, accounting and consulting fees directly attributable to the
issuance of an equity contract to be classified in equity are recorded as a reduction in equity. During September 2023, the Company incurred
$125,800 in deferred offering costs in connection with the Equity Distribution Agreement (the “Distribution Agreement”),
with Canaccord Genuity LLC (“Canaccord”) and the Purchase Agreement (the “Purchase Agreement”) with Lincoln Park
Capital Fund, LLC (“Lincoln Park”). These deferred offering costs will be proportionately offset against the total proceeds
from the issuance of common stock available under the agreements and the Company will expense any remaining balance of deferred offering
costs if the agreements are terminated. For the three and nine months ended September 30, 2023, there were no issuances of common stock
under the agreements resulting in the deferral of offering costs.
Warrant
Liability and Investment Options
The
Company evaluates all of its financial instruments, including issued stock purchase warrants and investment options, to determine if
such instruments are derivatives or contain features that qualify as embedded derivatives, pursuant to ASC 480 “Distinguishing
Liabilities from Equity” (“ASC 480”) and FASB ASC Topic 815, “Derivatives and Hedging” (“ASC 815”).
The Company accounts for warrants and investment options for shares of the Company’s common stock that are not indexed to its own
stock as derivative liabilities at fair value on the unaudited condensed consolidated balance sheets. The Company accounts for common
stock warrants and investment options with put options as liabilities under ASC 480. Such warrants and investment options are subject
to remeasurement at each unaudited condensed consolidated balance sheet date and any change in fair value is recognized as a component
of other expense on the unaudited condensed consolidated statements of operations. The Company will continue to adjust the liability
for changes in fair value until the earlier of the exercise or expiration of such common stock warrants and investment options. At that
time, the portion of the warrant liability and investment options related to such common stock warrants will be reclassified to additional
paid-in capital.
Derivative
Liability
The
Company evaluates its financial instruments to determine if such instruments are derivatives or contain features that qualify as embedded
derivatives in accordance with ASC 815. For derivative financial instruments that are accounted for as assets or liabilities, the derivative
instrument is initially recorded at its fair value on the grant date and is then re-valued at each reporting date, with changes in the
fair value reported in the unaudited condensed consolidated statements of operations. The classification of derivative instruments, including
whether such instruments should be recorded as assets or liabilities or as equity, is evaluated at the end of each reporting period.
Derivative liabilities are classified in the unaudited condensed consolidated balance sheets as current or non-current based on whether
or not net-cash settlement or conversion of the instrument could be required within 12 months of the balance sheet date.
Income
Taxes
The
Company files U.S. federal and state returns. The Company’s foreign subsidiary also files a local tax return in their local jurisdiction.
From a U.S. federal, state, and Canadian perspective, the years that remain open to examination are consistent with each jurisdiction’s
statute of limitations.
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Net
Loss per Share
Basic
net loss per share is computed by dividing net loss by the weighted average number of shares of common stock outstanding during the period.
Diluted earnings per share is computed using the weighted average number of common shares and, if dilutive, potential common shares outstanding
during the period. Potential common shares consist of the incremental common shares issuable upon the exercise of stock options and warrants
(using the treasury stock method). The computation of basic net loss per share for the three and nine months ended September 30, 2023
and 2022 excludes potentially dilutive securities. The computations of net loss per share for each period presented is the same for both
basic and fully diluted. In accordance with ASC 260 “Earnings per Share” (“ASC 260”), penny warrants were included
in the calculation of weighted average shares outstanding for the purposes of calculating basic and diluted earnings per share.
Potentially
dilutive securities outlined in the table below have been excluded from the computation of diluted net loss per share the three and nine
months ended September 30, 2023 and 2022 because the effect of their inclusion would have been anti-dilutive.
SCHEDULE
OF POTENTIALLY DILUTIVE SECURITIES
| |
For the three and nine months ended September 30, 2023 | | |
For the three and nine months ended September 30, 2022 | |
Warrants to purchase shares of common stock | |
| 609,893 | | |
| 655,463 | |
Restricted stock units - vested and unissued | |
| 20,847 | | |
| 61,428 | |
Restricted stock units - unvested | |
| 148,251 | | |
| 65,117 | |
Restricted stock awards - vested and unissued | |
| — | | |
| 974 | |
Investment options to purchase shares of common stock | |
| 1,070,000 | | |
| 1,070,000 | |
Options to purchase shares of common stock | |
| 31,852 | | |
| 22,829 | |
Total potentially dilutive securities | |
| 1,880,843 | | |
| 1,875,811 | |
Fair
Value Measurements
Fair
value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between
market participants at the measurement date. To increase the comparability of fair value measures, the following hierarchy prioritizes
the inputs to valuation methodologies used to measure fair value:
Level
1 - Valuations based on quoted prices for identical assets and liabilities in active markets.
Level
2 - Valuations based on observable inputs other than quoted prices included in Level 1, such as quoted prices for similar assets and
liabilities in active markets, quoted prices for identical or similar assets and liabilities in markets that are not active, or other
inputs that are observable or can be corroborated by observable market data.
Level
3 - Valuations based on unobservable inputs reflecting our own assumptions, consistent with reasonably available assumptions made by
other market participants. These valuations require significant judgment.
For
certain financial instruments, including cash and accounts payable, the carrying amounts approximate their fair values as of September
30, 2023, and December 31, 2022 because of their short-term nature.
The
following table provides the financial liabilities measured on a recurring basis and reported at fair value on the balance sheet as of
September 30, 2023, and December 31, 2022, and indicates the fair value of the valuation inputs the Company utilized to determine such
fair value of warrant liabilities, derivative liability, and investment options:
SCHEDULE
OF FAIR VALUE HIERARCHY OF VALUATION INPUTS ON RECURRING BASIS
| |
Level | |
September 30, 2023 | | |
December 31, 2022 | |
Warrant liabilities - January 2021 Warrants | |
3 | |
$ | 18 | | |
$ | 81 | |
Warrant liabilities - February 2021 Warrants | |
3 | |
| 59 | | |
| 79 | |
Warrant liabilities - February 2022 Warrants | |
3 | |
| 300,480 | | |
| 185,055 | |
Fair value of warrant liability | |
| |
$ | 300,557 | | |
$ | 185,215 | |
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
| |
Level | |
September 30, 2023 | | |
December 31, 2022 | |
Derivative liability - May 2022 | |
3 | |
$ | — | | |
$ | 727,000 | |
Fair value of derivative liability | |
| |
$ | — | | |
$ | 727,000 | |
| |
Level | |
September 30, 2023 | | |
December 31, 2022 | |
H.C. Wainwright & Co., LLC investment options | |
3 | |
$ | 70,521 | | |
$ | 44,904 | |
RD investment options | |
3 | |
| 442,653 | | |
| 302,289 | |
PIPE investment options | |
3 | |
| 737,755 | | |
| 503,815 | |
Fair value of investment option liability | |
| |
$ | 1,250,929 | | |
$ | 851,008 | |
The
warrant liabilities, derivative liability, and investment options are all classified as Level 3, for which there is no current market
for these securities such as the determination of fair value requires significant judgment or estimation. Changes in fair value measurement
categorized within Level 3 of the fair value hierarchy are analyzed each period based on changes in estimates or assumptions and recorded
within other income (expense) on the condensed consolidated statements of operations and comprehensive loss.
Subsequent
measurement
The
following table presents the changes in fair value of the warrant liabilities, derivative liability, and investment options that are
classified as Level 3:
SCHEDULE
OF FAIR VALUE OF WARRANT LIABILITIES AND DERIVATIVE LIABILITY AND INVESTMENT OPTIONS
| |
Total Warrant Liabilities | |
Fair value as of December 31, 2022 | |
$ | 185,215 | |
Change in fair value | |
| 115,342 | |
Fair value as of September 30, 2023 | |
$ | 300,557 | |
| |
Total Derivative Liability | |
Fair value as of December 31, 2022 | |
$ | 727,000 | |
Change in fair value arising from redemption of Akos Series A Preferred Stock - See Note 8 | |
| (727,000 | ) |
Fair value of derivative liability as of September 30, 2023 | |
$ | — | |
| |
Total Investment Option Liability | |
Fair value as of December 31, 2022 | |
$ | 851,008 | |
Change in fair value | |
| 399,921 | |
Fair value of investment option liability as of September 30, 2023 | |
$ | 1,250,929 | |
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
The
key inputs into the Black Scholes valuation model for the Level 3 valuations of the warrant liabilities as of September 30, 2023 are
below:
SCHEDULE
OF BLACK SCHOLES VALUATION MODELS OF WARRANT LIABILITIES AND INVESTMENT OPTIONS
| |
January 2021 Warrants | | |
February 2021 Warrants | | |
February 2022 Warrants | | |
February 2022 Post-Modification Warrants | |
Term (years) | |
| 2.3 | | |
| 2.4 | | |
| 3.4 | | |
| 4.3 | |
Stock price | |
$ | 2.38 | | |
$ | 2.38 | | |
$ | 2.38 | | |
$ | 2.38 | |
Exercise price | |
$ | 247.50 | | |
$ | 245.00 | | |
$ | 27.50 | | |
$ | 7.78 | |
Dividend yield | |
| — | % | |
| — | % | |
| — | % | |
| — | % |
Expected volatility | |
| 80.0 | % | |
| 85.0 | % | |
| 96.0 | % | |
| 94.0 | % |
Risk free interest rate | |
| 5.00 | % | |
| 4.90 | % | |
| 4.80 | % | |
| 4.70 | % |
Number of warrants | |
| 36,429 | | |
| 34,281 | | |
| 338,000 | | |
| 122,000 | |
Value (per share) | |
$ | — | | |
$ | — | | |
$ | 0.46 | | |
$ | 1.18 | |
The
key inputs into the Black Scholes valuation model for the Level 3 valuations of the investment options as of September 30, 2023 are below:
| |
H.C. Wainwright & Co., LLC Options | | |
RD Offering Options | | |
PIPE Offering Options | |
Term (years) | |
| 3.8 | | |
| 4.3 | | |
| 4.3 | |
Stock price | |
$ | 2.38 | | |
$ | 2.38 | | |
$ | 2.38 | |
Exercise price | |
$ | 10.00 | | |
$ | 7.78 | | |
$ | 7.78 | |
Dividend yield | |
| — | % | |
| — | % | |
| — | % |
Expected volatility | |
| 97.0 | % | |
| 94.0 | % | |
| 94.0 | % |
Risk free interest rate | |
| 4.70 | % | |
| 4.70 | % | |
| 4.70 | % |
Number of investment options | |
| 70,000 | | |
| 375,000 | | |
| 625,000 | |
Value (per share) | |
$ | 1.01 | | |
$ | 1.18 | | |
$ | 1.18 | |
The
key inputs into the Weighted Expected Return valuation model for the Level 3 valuations of the derivative liability as of redemption,
are below:
| |
| May 2022 Derivative Liability | |
Principal | |
$ | — | |
Dividend rate | |
| — | % |
Market rate | |
| — | % |
At
the date of the redemption of the of Akos Series A Preferred Stock in May 2023, the derivative liability fair value was $0 due to the
probability of a spin-off occurring was zero. See Note 8
Redeemable
Non-controlling Interest
In
connection with the issuance of Akos Series A Preferred Stock, the Akos Purchase Agreement (as defined below in Note 8) and certificate
of designation contain a put right guaranteed by the Company as defined in Note 8. Applicable accounting guidance requires an equity
instrument that is redeemable for cash or other assets to be classified outside of permanent equity if it is redeemable (a) at a fixed
or determinable price on a fixed or determinable date, (b) at the option of the holder, or (c) upon the occurrence of an event that is
not solely within the control of the issuer. As a result of this feature, the Company recorded the non-controlling interests as redeemable
non-controlling interests and classified them in mezzanine equity within its unaudited condensed consolidated balance sheet initially
at its acquisition-date estimated redemption value or fair value. In addition, the Company has elected to recognize changes in the redemption
value immediately as they occur and adjust the carrying amount of the instrument by accreting the embedded derivative at each reporting
period over 12 months.
In
May 2023, pursuant to the Akos Series A Preferred Certificate of Designations, the holders of the Akos Series A Preferred Stock exercised
the Put Right (as defined below) requiring Akos to force redemption of all of the Akos Series A Preferred Stock. See Note 8.
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Segment
Reporting
The
Company determines its reporting units in accordance with FASB ASC 280, “Segment Reporting” (“ASC 280”). The
Company evaluates a reporting unit by first identifying its operating segments under ASC 280. The Company then evaluates each operating
segment to determine if it includes one or more components that constitute a business. If there are components within an operating segment
that meet the definition of a business, the Company evaluates those components to determine if they must be aggregated into one or more
reporting units. If applicable, when determining if it is appropriate to aggregate different operating segments, the Company determines
if the segments are economically similar and, if so, the operating segments are aggregated. The Company has multiple operations related
to psychedelics and cannabinoids. Both of these operations exist under one reporting unit: Enveric. The Company has one operating segment
and reporting unit. The Company is organized and operated as one business. Management reviews its business as a single operating segment,
using financial and other information rendered meaningful only by the fact that such information is presented and reviewed in the aggregate.
Recent
Accounting Pronouncements
In
August 2020, the FASB issued ASU 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives
and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40) (“ASU 2020-06”) to simplify certain financial
instruments. ASU 2020-06 eliminates the current models that require separation of beneficial conversion and cash conversion features
from convertible instruments and simplifies the derivative scope exception guidance pertaining to equity classification of contracts
in an entity’s own equity. The new standard also introduces additional disclosures for convertible debt and freestanding instruments
that are indexed to and settled in an entity’s own equity. ASU 2020-06 amends the diluted earnings per share guidance, including
the requirement to use the if-converted method for all convertible instruments. ASU 2020-06 is effective for fiscal years beginning after
December 15, 2023, and should be applied on a full or modified retrospective basis. Early adoption is permitted, but no earlier than
fiscal years beginning after December 15, 2020, including interim periods within those fiscal years. The Company early adopted ASU 2020-06
effective January 1, 2023, and has determined that the adoption of this guidance had no impact on its condensed consolidated financial
statements.
NOTE
3. PREPAID EXPENSES AND OTHER CURRENT ASSETS
As
of September 30, 2023 and December 31, 2022, the prepaid expenses and other current assets of the Company consisted of the following:
SCHEDULE
OF PREPAID EXPENSES AND OTHER CURRENT ASSETS
| |
September 30, 2023 | | |
December 31, 2022 | |
Prepaid research and development | |
$ | 651,623 | | |
$ | 268,686 | |
Prepaid value-added taxes | |
| 229,909 | | |
| 159,782 | |
Prepaid professional fees | |
| 74,500 | | |
| — | |
Prepaid insurance | |
| 332,508 | | |
| 174,406 | |
Prepaid other | |
| 146,014 | | |
| 105,179 | |
Deferred offering costs | |
| 125,800 | | |
| — | |
Total prepaid expenses and other current assets | |
$ | 1,560,354 | | |
$ | 708,053 | |
NOTE
4. INTANGIBLE ASSETS
As
of September 30, 2023, the Company’s intangible assets consisted of:
SCHEDULE
OF FINITE LIVED INTANGIBLE ASSETS
Definite lived intangible assets | |
| | |
Balance at December 31, 2022 | |
$ | 379,686 | |
Amortization | |
| (126,566 | ) |
Balance at September 30, 2023 | |
$ | 253,120 | |
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
For
identified definite lived intangible assets, there was no impairment expense during the three and nine months ended September 30, 2023
and 2022. For identified definite lived intangible assets, amortization expense amounted to $42,191 during the three months ended September
30, 2023, and 2022, respectively. For identified definite lived intangible assets, amortization expense amounted to $126,566 and $126,563
during the nine months ended September 30, 2023 and 2022.
NOTE
5. PROPERTY AND EQUIPMENT
Property
and equipment consists of the following assets which are located in Calgary, Canada and placed in service by Enveric Biosciences Canada,
Inc. (“EBCI”), with all amounts translated into U.S. dollars:
SCHEDULE OF PROPERTY PLANT AND EQUIPMENT NET OF ACCUMULATED DEPRECIATION
| |
September 30, 2023 | | |
December 31, 2022 | |
Lab equipment | |
$ | 818,460 | | |
$ | 831,123 | |
Computer equipment and leasehold improvements | |
| 27,759 | | |
| 25,137 | |
Less: Accumulated depreciation | |
| (307,067 | ) | |
| (178,775 | ) |
Property and equipment, net of accumulated depreciation | |
$ | 539,152 | | |
$ | 677,485 | |
Depreciation
expense was $44,105 and $44,458 for the three months ended September 30, 2023, and 2022, respectively. Depreciation expense was $132,734
and $114,850 for the nine months ended September 30, 2023 and 2022, respectively.
NOTE
6. ACCRUED LIABILITIES
As
of September 30, 2023 and December 31, 2022, the accrued liabilities of the Company consisted of the following:
SCHEDULE
OF ACCRUED LIABILITIES
| |
September 30, 2023 | | |
December 31, 2022 | |
Product development | |
$ | 94,663 | | |
$ | 195,104 | |
Accrued salaries and wages | |
| 729,616 | | |
| 1,175,963 | |
Professional fees | |
| 74,499 | | |
| 83,255 | |
Accrued restructuring costs | |
| 607,602 | | |
| — | |
Accrued franchise taxes | |
| 9,449 | | |
| — | |
Patent costs | |
| 18,000 | | |
| 251,333 | |
Total accrued expenses | |
$ | 1,533,829 | | |
$ | 1,705,655 | |
NOTE
7. SHARE CAPITAL AND OTHER EQUITY INSTRUMENTS
Authorized
Capital
The
holders of the Company’s common stock are entitled to one vote per share. Holders of common stock are entitled to receive ratably
such dividends, if any, as may be declared by the Board of Directors out of legally available funds. Upon the liquidation, dissolution,
or winding up of the Company, holders of common stock are entitled to share ratably in all assets of the Company that are legally available
for distribution. As of September 30, 2023, 100,000,000 shares of common stock and 20,000,000 shares of Preferred Stock were authorized
under the Company’s articles of incorporation.
Equity
Distribution Agreement
On
September 1, 2023, the Company entered into the Distribution Agreement, with Canaccord, pursuant to which the Company may offer and sell
from time to time, through Canaccord as sales agent and/or principal, shares of common stock of the Company, par value $0.01 per share
having an aggregate offering price of up to $10.0 million. Due to the offering limitations applicable to the Company and in accordance
with the terms of the Distribution Agreement, the Company may offer Common Stock having an aggregate gross sales price of up to $2,392,514
pursuant to the prospectus supplement dated September 1, 2023 (the “Prospectus Supplement”). Subject to the terms and conditions
of the Distribution Agreement, Canaccord may sell the Common Stock by any method permitted by law deemed to be an “at-the-market
offering”. The Company will pay Canaccord a commission equal to 3.0% of the gross sales price of the Common Stock sold through
Canaccord under the Distribution Agreement and has also agreed to reimburse Canaccord for certain expenses. The Company may also sell
Common Stock to Canaccord as principal for Canaccord’s own account at a price agreed upon at the time of sale. Any sale of Common
Stock to Canaccord as principal would be pursuant to the terms of a separate terms agreement between the Company and Canaccord.
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
During
the three and nine months ended September 30, 2023, the Company has issued no shares of common stock through the Distribution Agreement.
The Company had capitalized deferred offering costs of $125,800 related to establishing the Distribution Agreement with Canaccord and
the Purchase Agreement with Lincoln Park and no reductions to additional paid in capital.
Common
Stock Activity
On
February 15, 2022, the Company completed a public offering of 400,000 shares of Common Stock and warrants to purchase up to 400,000 shares
of Common Stock for gross proceeds of approximately $10.0 million, before deducting underwriting discounts and commissions and other
offering expenses. A.G.P./Alliance Global Partners acted as sole book-running manager for the offering. In addition, Enveric granted
the underwriter a 45-day option to purchase up to an additional 60,000 shares of Common Stock and/or warrants to purchase up to an additional
60,000 shares of Common Stock at the public offering price, which the underwriter has partially exercised for warrants to purchase up
to 60,000 shares of common stock. At closing, Enveric received net proceeds from the offering of approximately $9.1 million, after deducting
underwriting discounts and commissions and estimated offering expenses with $5.8 million allocated to equity, $3.6 million to warrant
liability and the remaining $0.3 million recorded as an expense.
On
July 22, 2022, the Company entered into a securities purchase agreement (the “Registered Direct Securities Purchase Agreement”)
with an institutional investor for the purchase and sale of 116,500 shares of the Company’s common stock, pre-funded warrants to
purchase up to 258,500 shares of common stock (the “RD Pre-Funded Warrants”), and unregistered preferred investment options
(the “RD Preferred Investment Options”) to purchase up to 375,000 shares of common stock (the “RD Offering”).
The gross proceeds from the RD Offering were approximately $3,000,000. Subject to certain ownership limitations, the RD Pre-Funded Warrants
became immediately exercisable at an exercise price equal to $0.0001 per share of common stock. On August 3, 2022, all of the issued
RD Pre-Funded Warrants were exercised.
Concurrently
with the RD Offering, the Company entered into a securities purchase agreement (the “PIPE Securities Purchase Agreement”)
with institutional investors for the purchase and sale of 116,000 shares of common stock, pre-funded warrants to purchase up to 509,000
shares of common stock (the “PIPE Pre-Funded Warrants”), and preferred investment options (the “PIPE Preferred Investment
Options”) to purchase up to 625,000 shares of the common stock in a private placement (the “PIPE Offering”). The gross
proceeds from the PIPE Offering were approximately $5,000,000. Subject to certain ownership limitations, the PIPE Pre-Funded Warrants
became immediately exercisable at an exercise price equal to $0.0001 per share of common stock. All of the issued PIPE Pre-Funded Warrants
were exercised on various dates prior to August 18, 2022.
The
RD Offering and PIPE Offering closed on July 26, 2022, with aggregate gross proceeds of approximately $8 million. The aggregate net proceeds
from the offerings, after deducting the placement agent fees and other estimated offering expenses, were approximately $7.1 million,
with $3.2 million allocated to equity, $4.3 million to investment option liability, and the remaining $0.4 million recorded as an expense.
During
the nine months ended September 30, 2023, a total of 103,641 shares of Common Stock were issued pursuant to the conversion of restricted
stock units. During the nine months ended September 30, 2022, a total of 2,122 shares of Common Stock were issued pursuant to the conversion
of restricted stock units.
Stock
Options
Amendment
to 2020 Long-Term Incentive Plan
On
May 3, 2022, our board of directors (“Board”) adopted the First Amendment (the “Plan Amendment”) to the Enveric
Biosciences, Inc. 2020 Long-Term Incentive Plan (the “Incentive Plan”) to (i) increase the aggregate number of shares available
for the grant of awards by 146,083 shares to a total of 200,000 shares, and (ii) add an “evergreen” provision whereby the
number of shares authorized for issuance pursuant to awards under the Incentive Plan will be automatically increased on the first trading
date immediately following the date the Company issues any share of Common Stock (defined below) to any person or entity, to the extent
necessary so that the number of shares of the Company’s Common Stock authorized for issuance under the Incentive Plan will equal
the greater of (x) 200,000 shares, and (y) 15% of the total number of shares of the Company’s Common Stock outstanding as of such
issuance date. The Plan Amendment was approved by the Company’s shareholders at a special meeting of the Company’s shareholders
held on July 14, 2022.
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
A
summary of activity under the Company’s incentive plan for the nine months ended September 30, 2023, is presented below:
SCHEDULE OF STOCK OPTION
| |
Number of Shares | | |
Weighted Average Exercise Price | | |
Weighted Average Grant Date Fair Value | | |
Weighted Average Remaining Contractual Term (years) | | |
Aggregate Intrinsic Value | |
Outstanding at December 31, 2022 | |
| 48,329 | | |
$ | 37.05 | | |
$ | 44.82 | | |
| 4.1 | | |
$ | — | |
Forfeited | |
| (16,476 | ) | |
$ | 5.79 | | |
$ | 5.80 | | |
| — | | |
$ | — | |
Outstanding at September 30, 2023 | |
| 31,852 | | |
$ | 53.18 | | |
$ | 74.04 | | |
| 3.4 | | |
$ | — | |
Exercisable at September 30, 2023 | |
| 24,626 | | |
$ | 63.72 | | |
$ | 86.52 | | |
| 3.0 | | |
$ | — | |
The
Company’s stock-based compensation expense, recorded within general and administrative expense in the condensed consolidated statement
of operations and comprehensive loss, related to stock options for the three months ended September 30, 2023, and 2022 was $44,606 and
$48,697, respectively. The Company’s stock-based compensation expense, recorded within general and administrative expense, related
to stock options for the nine months ended September 30, 2023 and 2022 was $147,067 and $134,383, respectively. As of September 30, 2023,
the Company had $93,697 in unamortized stock option expense, which will be recognized over a weighted average period of 1 year.
Restricted
Stock Awards
For
the three months ended September 30, 2023, and 2022, the Company recorded $0 and $6,250, respectively, in stock-based compensation expense
within general and administrative expense, related to restricted stock awards. For the nine months ended September 30, 2023 and 2022,
the Company recorded $0 and $24,363, respectively, in stock-based compensation expense within general and administrative expense, related
to restricted stock awards. As of September 30, 2023, there were no unamortized stock-based compensation costs related to restricted
share awards. During the three months ended September 30, 2023, the Company settled the 708 vested and unissued shares for cash of $14,250.
As of September 30, 2023, there are 0 vested and unissued shares of restricted stock awards.
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Issuance
of Restricted Stock Units
The
Company’s activity in restricted stock units was as follows for the nine months ended September 30, 2023:
SCHEDULE OF RESTRICTED STOCK UNITS AND AWARDS ACTIVITY
| |
Number of shares | | |
Weighted average
fair value | |
Non-vested at December 31, 2022 | |
| 64,053 | | |
$ | 92.57 | |
Granted | |
| 182,500 | | |
$ | 2.73 | |
Vested | |
| (62,636 | ) | |
$ | 19.80 | |
Forfeited | |
| (35,666 | ) | |
$ | 27.45 | |
Non-vested at September 30, 2023 | |
| 148,251 | | |
$ | 28.39 | |
For
the three months ended September 30, 2023, and 2022, the Company recorded $328,253 and $590,190, respectively, in stock-based compensation
expense related to restricted stock units. For the nine months ended September 30, 2023 and 2022, the Company recorded $1,638,365 and
$1,932,553 respectively, in stock-based compensation expense related to restricted stock units, which is a component of both general
and administrative and research and development expenses in the condensed consolidated statement of operations and comprehensive loss.
As of September 30, 2023, the Company had unamortized stock-based compensation costs related to restricted stock units of $2,388,221
which will be recognized over a weighted average period of 2.3 years and unamortized stock-based costs related to restricted stock units
which will be recognized upon achievement of specified milestones. As of September 30, 2023, 20,847 restricted stock units are vested
without shares of common stock being issued, with all of these shares due as of September 30, 2023.
The
following table summarizes the Company’s recognition of stock-based compensation for restricted stock units for the following periods:
SCHEDULE OF STOCK-BASED COMPENSATION FOR RESTRICTED STOCK UNITS
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three months ended
September 30, | | |
Nine months ended
September 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Stock-based compensation expense for RSUs: | |
| | | |
| | | |
| | | |
| | |
General and administrative | |
$ | 101,607 | | |
$ | 357,756 | | |
$ | 946,851 | | |
$ | 1,138,080 | |
Research and development | |
| 226,646 | | |
| 232,434 | | |
| 691,514 | | |
| 794,473 | |
Total | |
$ | 328,253 | | |
$ | 590,190 | | |
$ | 1,638,365 | | |
$ | 1,932,553 | |
Warrants
The
following table summarizes information about shares issuable under warrants outstanding on September 30, 2023:
SCHEDULE
OF WARRANTS OUTSTANDING
| |
Warrant shares outstanding | | |
Weighted average exercise price | | |
Weighted average remaining life | | |
Intrinsic value | |
Outstanding at December 31, 2022 | |
| 655,463 | | |
$ | 58.36 | | |
| 3.6 | | |
$ | 5,514 | |
Expired | |
| (45,570 | ) | |
$ | 111.50 | | |
| — | | |
$ | — | |
Outstanding at September 30, 2023 | |
| 609,893 | | |
$ | 50.46 | | |
| 2.9 | | |
$ | — | |
Exercisable at September 30, 2023 | |
| 609,893 | | |
$ | 50.46 | | |
| 2.9 | | |
$ | — | |
The
warrants assumed pursuant to the acquisition of MagicMed contain certain down round features, which were not triggered by the February
2022 public offering and July 2022 RD Offering, that would require adjustment to the exercise price upon certain events when the offering
price is less than the stated exercise price.
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Preferred
Investment Options
The
following table summarizes information about investment options outstanding on September 30, 2023:
SCHEDULE
OF WARRANTS AND INVESTMENT OPTIONS
| |
Investment options outstanding | | |
Weighted average exercise price | | |
Weighted average remaining life | | |
Intrinsic value | |
Outstanding at December 31, 2022 | |
| 1,070,000 | | |
$ | 7.93 | | |
| 5.1 | | |
$ | — | |
Outstanding at September 30, 2023 | |
| 1,070,000 | | |
$ | 7.93 | | |
| 4.3 | | |
$ | — | |
Exercisable at September 30, 2023 | |
| 1,070,000 | | |
$ | 7.93 | | |
| 4.3 | | |
$ | — | |
NOTE
8. REDEEMABLE NON-CONTROLLING INTEREST
Spin-Off
and Related Private Placement
In
connection with the Spin-Off, on May 5, 2022, Akos and the Company entered into into a Securities Purchase Agreement (the “Akos
Purchase Agreement”) with an accredited investor (the “Akos Investor”), pursuant to which Akos agreed to sell up to
an aggregate of 5,000 shares of Akos Series A Preferred Stock, at price of $1,000 per share, and warrants (the “Akos Warrants”)
Akos Warrants to purchase shares of Akos’ common stock, par value $0.01 per share (the “Akos Common Stock”), for an
aggregate purchase price of up to $5,000,000 (the “Akos Private Placement”). The Akos Purchase Agreement was guaranteed by
the Company. Pursuant to the Akos Purchase Agreement, Akos issued 1,000 shares of the Akos Series A Preferred Stock to the Akos Investor
in exchange for $1,000,000 on May 5, 2022. The additional $4,000,000 was to be received on or immediately prior to the Spin-Off. The
issuance of the Akos Series A Preferred Stock results in RNCI (see Note 2). Palladium Capital Advisors, LLC (“Palladium”)
acted as placement agent for the Akos Private Placement. Pursuant to the Akos Purchase Agreement, Akos had agreed to pay Palladium a
fee equal to 9% of the aggregate gross proceeds raised from the sale of the shares of the Akos Series A Preferred Stock and a non-accountable
expense allowance of 1% of the aggregate gross proceeds raised the sale of the Akos Series A Preferred Stock in the Akos Private Placement.
The fee due in connection with the Akos Private Placement to be paid to Palladium in the form of convertible preferred stock and warrants
was on similar terms to the securities issued in the Akos Private Placement. Palladium was also entitled to warrants to purchase Akos
Common Stock in an amount up to 8% of the number of shares of Akos Common Stock underlying the shares issuable upon conversion of the
Akos Series A Preferred Stock. As of September 30, 2023, no accruals are required to be recorded for the fees or warrants since the Akos
Series A Preferred Stock has been redeemed.
Terms
of Akos Series A Preferred Stock
Under
the Certificate of the Designations, Preferences, and Rights of Series A Convertible Preferred Stock of Akos (the “Akos Series
A Preferred Certificate of Designations”), on or immediately prior to the completion of the spin-off of Akos into an independent,
separately traded public company listed on the Nasdaq Stock Market, the outstanding Akos Series A Preferred Stock automatically converted
into a number of shares of Akos Common Stock equal to 25% of the then issued and outstanding Akos Common Stock, subject to the Beneficial
Ownership Limitation (as defined in the Akos Purchase Agreement). Cumulative dividends on each share of Akos Series A Preferred Stock
accrue at the rate of 5% annually.
The
Akos Series A Preferred Certificate of Designations provided that upon the earlier of (i) the one-year anniversary of May 5, 2022, and
only in the event that the Spin-Off has not occurred; or (ii) such time that Akos and the Company have abandoned the Spin-Off or the
Company is no longer pursuing the Spin-Off in good faith, the holders of the Akos Series A Preferred Stock shall have the right (the
“Put Right”), but not the obligation, to cause Akos to purchase all or a portion of the Akos Series A Preferred Stock for
a purchase price equal to $1,000 per share, subject to certain adjustments as set forth in the Akos Series A Preferred Certificate of
Designations (the “Stated Value”), plus all the accrued but unpaid dividends per share. In addition, after the one-year anniversary
of May 5, 2022, and only in the event that the Spin-Off has not occurred and Akos is not in material default of any of the transaction
documents, Akos may, at its option, at any time and from time to time, redeem the outstanding shares of Akos Series A Preferred Stock,
in whole or in part, for a purchase price equal to the aggregate Stated Value of the shares of Akos Series A Preferred Stock being redeemed
and the accrued and unpaid dividends on such shares. Pursuant to the Akos Purchase Agreement, the Company has guaranteed the payment
of the purchase price for the shares purchased under the Put Right.
The
Akos Series A Preferred Certificate of Designations contains limitations that prevent the holder thereof from acquiring shares of Akos
Common Stock upon conversion of the Akos Series A Preferred Stock that would result in the number of shares of Akos Common Stock beneficially
owned by such holder and its affiliates exceeding 9.99% of the total number of shares of Akos Common Stock outstanding immediately after
giving effect to the conversion (the “Beneficial Ownership Limitation”), except that upon notice from the holder to Akos,
the holder may increase or decrease the limit of the amount of ownership of outstanding shares of Akos Common Stock after converting
the holder’s shares of Akos Series A Preferred Stock, provided that any change in the Beneficial Ownership Limitation shall not
be effective until 61 days following notice to Akos.
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Redemption
of Akos Series A Preferred Stock
In
May 2023, pursuant to the Akos Series A Preferred Certificate of Designations, the holders of the Akos Series A Preferred Stock exercised
the Put Right requiring Akos to force redemption of all of the Akos Series A Preferred Stock for $1,000 per share, plus accrued
but unpaid dividends of approximately $52,000 for a total of approximately $1,052,000. The Company had 20 days following the receipt
of the Put Exercise Notice to make the payment and made payment on May 19, 2023. Upon redemption in May 2023, the Company revalued the
derivative liability and the Company recognized a change in fair value of the derivative liability on the Company’s condensed consolidated
statement of operations during the second quarter of 2023 of $714,000.
The
Company, Akos, and the Akos Investor have terminated the Akos Purchase Agreement in connection with the planned Spin-Off and certain
registration rights agreement in connection with the Akos Private Placement.
Accounting
for Akos Series A Preferred Stock
Since
the shares of Akos Series A Preferred Stock were redeemable at the option of the holder and the redemption is not solely in the control
of the Company, the shares of Akos Series A Preferred Stock were accounted for as a redeemable non-controlling interest and classified
within mezzanine equity in the Company’s condensed consolidated balance sheets. The redeemable non-controlling interest was initially
measured at fair value. Dividends on the shares of Akos Series A Preferred Stock were recognized as preferred dividends attributable
to redeemable non-controlling interest in the Company’s condensed consolidated statement of operations and comprehensive loss.
The
table below presents the reconciliation of changes in redeemable non-controlling interest:
SCHEDULE OF RECONCILIATION CHANGE IN REDEEMABLE NONCONTROLLING INTEREST
Balance at December 31, 2022 | |
$ | 885,028 | |
Preferred dividends attributable to redeemable non-controlling interest | |
| 19,041 | |
Accretion of embedded derivative and transaction costs associated with Akos Series A Preferred | |
| 147,988 | |
Redemption of Akos Series A Preferred Stock | |
| (1,052,057 | ) |
Balance at September 30, 2023 | |
$ | — | |
In
May 2023, the Akos Series A Preferred Stock was redeemed for a total of $1,052,057, and the balance of the redeemable non-controlling
interest is $0 as of September 30, 2023.
NOTE
9. COMMITMENTS AND CONTINGENCIES
The
Company is periodically involved in legal proceedings, legal actions and claims arising in the normal course of business. Management
believes that the outcome of such legal proceedings, legal actions and claims will not have a significant adverse effect on the Company’s
financial position, results of operations or cash flows.
Australian
Subsidiary Research and Development
On
March 23, 2023, the Company issued a press release announcing the selection of Australian CRO, Avance Clinical, in preparation for Phase
1 Study of EB-373, the Company’s lead candidate targeting the treatment of anxiety disorders. Under the agreement, Avance Clinical
will manage the Phase 1 clinical trial of EB-373 in coordination with the Company’s newly established Australian subsidiary, Enveric
Therapeutics Pty, Ltd. The Phase 1 clinical trial is designed as a multi-cohort, dose-ascending study to measure the safety and tolerability
of EB-373. EB-373, a next-generation proprietary psilocin prodrug, has been recognized as a New Chemical Entity (NCE) by Australia’s
Therapeutic Goods Administration (TGA) and is currently in preclinical development targeting the treatment of anxiety disorder. The total
cost of the Avance Clinical contract is approximately 3,000,000 AUD, which translates to approximately $2,000,000 USD as of September
30, 2023. As of September 30, 2023, the Company has paid approximately $950,997 of the Avance Clinical contract costs and has $549,713
recorded as prepaid assets within prepaid and other current assets on the accompanying condensed consolidated balance sheet. For the
three and nine months ended September 30, 2023, the Company has expensed $157,117 and $401,284 in research and development expenses,
respectively, within the accompanying condensed consolidated statement of operations.
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Development
and Clinical Supply Agreement
On
February 22, 2021, the Company entered into a Development and Clinical Supply Agreement (the “PureForm Agreement”) with PureForm
Global, Inc. (“PureForm”), pursuant to which PureForm will be the exclusive provider of synthetic cannabidiol (“API”)
for the Company’s development plans for cancer treatment and supportive care. Under the terms of the PureForm Agreement, PureForm
has granted the Company the exclusive right to purchase API and related product for cancer treatment and supportive care during the term
of the Agreement (contingent upon an initial minimum order of 1 kilogram during the first thirty (30) days from the effective date) and
has agreed to manufacture, package and test the API and related product in accordance with specifications established by the parties.
All inventions that are developed jointly by the parties in the course of performing activities under the PureForm Agreement will be
owned jointly by the parties in accordance with applicable law; however, if the Company funds additional research and development efforts
by PureForm, the parties may enter into a further agreement whereby PureForm would assign any resulting inventions or technical information
to the Company.
The
initial term of the PureForm Agreement is three (3) years commencing on the effective date of the PureForm Agreement, subject to extension
by mutual agreement of the parties. The PureForm Agreement may be terminated by either party upon thirty (30) days written notice of
an uncured material breach or immediately in the event of bankruptcy or insolvency. The PureForm Agreement contains, among other provisions,
representation and warranties, indemnification obligations and confidentiality provisions in favor of each party that are customary for
an agreement of this nature.
The
Company has met the minimum purchase requirement of 1 kilogram during the first thirty days of the PureForm Agreement’s effectiveness.
Purchase
agreement with Prof. Zvi Vogel and Dr. Ilana Nathan
On
December 26, 2017, Jay Pharma entered into a purchase agreement with Prof. Zvi Vogel and Dr. Ilana Nathan (the “Vogel-Nathan Purchase
Agreement”), pursuant to which Jay Pharma was assigned ownership rights to certain patents, which were filed and unissued as of
the date of the Vogel-Nathan Purchase Agreement. The Vogel-Nathan Purchase Agreement includes a commitment to pay a one-time milestone
totaling $200,000 upon the issuance of a utility patent in the United States or by the European Patent Office, as defined in the agreement.
The Company has accrued such amount as of December 31, 2021, as a result of the milestone criteria being achieved. Payment was made during
January 2022. In addition, a milestone payment totaling $300,000 is due upon initiation of a Phase II(b) study. Research activities related
to the relevant patents are still in pre-clinical stage, and accordingly, this milestone has not been achieved. The Vogel-Nathan Purchase
Agreement contains a commitment for payment of royalties equaling 2% of the first $20 million in net sales derived from the commercialization
of products utilizing the relevant patent. As these products are still in the preclinical phase of development, no royalties have been
earned.
Other
Consulting and Vendor Agreements
The
Company has entered into a number of agreements and work orders for future consulting, clinical trial support, and testing services,
with terms ranging between 1 and 18 months. These agreements, in aggregate, commit the Company to approximately $1.2 million in future
cash payments.
NOTE
10. SUBSEQUENT EVENTS
Lincoln
Park Equity Line
On
November 3, 2023, the Company entered into a Purchase Agreement and a registration rights agreement (the “Registration Rights Agreement”),
with Lincoln Park, pursuant to which Lincoln Park has committed to purchase up to $10.0 million of the Company’s common stock,
par value $0.01 per share subject to certain limitations and satisfaction of the conditions set forth in the Purchase Agreement.
Under
the terms and subject to the conditions of the Purchase Agreement, the Company has the right, but not the obligation, to sell to Lincoln
Park, and Lincoln Park is obligated to purchase up to $10.0 million of the Company’s Common Stock (the “Purchase Shares”).
However, such sales of Common Stock by the Company, if any, will be subject to important limitations set forth in the Purchase Agreement,
including limitations on number of shares that may be sold. Sales may occur from time to time, at the Company’s sole discretion,
over the 24-month period commencing on the date that the conditions to Lincoln Park’s purchase obligation set forth in the Purchase
Agreement are satisfied, including that a registration statement on Form S-1 covering the resale of the shares of our Common Stock that
have been and may be issued to Lincoln Park under the Purchase Agreement, which the Company has filed with the SEC pursuant to the Registration
Rights Agreement, is declared effective by the SEC and a final prospectus relating thereto is filed with the SEC.
Because
the purchase price per share to be paid by Lincoln Park for the shares of Common Stock that we may elect to sell to Lincoln Park under
the Purchase Agreement, if any, will fluctuate based on the market prices of our Common Stock at the time we elect to sell shares to
Lincoln Park pursuant to the Purchase Agreement, if any, it is not possible for us to predict the number of shares of Common Stock that
we will sell to Lincoln Park under the Purchase Agreement, the purchase price per share that Lincoln Park will pay for shares purchased
from us under the Purchase Agreement, or the aggregate gross proceeds that we will receive from those purchases by Lincoln Park under
the Purchase Agreement.
For
additional details, please refer to the Company’s Current Report on Form 8-K filed with the SEC on November 6, 2023.
2020
Long-Term Incentive Plan Amended
On
November 2, 2023, the shareholders approved the amendments to the 2020 Long-Term Incentive Plan, which was approved by the Board on August
8, 2023 (the “Amended Incentive Plan”). The Amended Incentive Plan increased the number of authorized shares reserved for
issuance under the Amended Incentive Plan to a maximum of 350,000, subject to adjustment.
Item
2. Management’s discussion and analysis of financial condition and results of operations
The
information set forth below should be read in conjunction with the unaudited condensed consolidated financial statements and notes thereto
included elsewhere in this Quarterly Report on Form 10-Q. Unless stated otherwise, references in this Quarterly Report on Form 10-Q to
“us,” “we,” “our,” or our “Company” and similar terms refer to Enveric Biosciences, Inc.,
a Delaware corporation.
Cautionary
Note Regarding Forward-Looking Statements
This
quarterly report on Form 10-Q (this “Form 10-Q”) contains forward-looking statements within the meaning of the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of forward-looking
terms such as “anticipates,” “assumes,” “believes,” “can,” “could,” “estimates,”
“expects,” “forecasts,” “guides,” “intends,” “is confident that,” “may,”
“plans,” “seeks,” “projects,” “targets,” and “would” or the negative of such
terms or other variations on such terms or comparable terminology. Such forward-looking statements include, but are not limited to, future
financial and operating results, the company’s plans, objectives, expectations and intentions and other statements that are not
historical facts. We have based these forward-looking statements largely on our current expectations and projections about future events
and financial trends that we believe may affect our business, financial condition, and results of operations. These forward-looking statements
speak only as of the date of this Form 10-Q and are subject to a number of risks, uncertainties, and assumptions that could cause actual
results to differ materially from our historical experience and our present expectations, or projections described under the sections
in this Form 10-Q entitled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and
Results of Operations.” These risks and uncertainties include, but are not limited to:
| ● | our
dependence on the success of our prospective product candidates, which are in the early stages
of development and may not reach a particular stage in development, receive regulatory approval,
or be successfully commercialized; |
| ● | potential
difficulties that may delay, suspend, or scale back our efforts to advance additional early
research programs through preclinical development and investigational new drug (“IND”)
application filings and into clinical development; |
| ● | the
risk that the cost savings, synergies and growth from our combination with MagicMed Industries
Inc. and the successful use of the rights and technologies acquired in the combination may
not be fully realized or may take longer to realize than expected; |
| ● | the
ongoing impact of the novel coronavirus (COVID-19) on our business, including our current
plans for product development, as well as any currently ongoing preclinical studies and clinical
trials and any future studies or other development or commercialization activities; |
| ● | the
limited study on the effects of medical cannabinoids and psychedelics, and the chance that
future clinical research studies may lead to conclusions that dispute or conflict with our
understanding and belief regarding the medical benefits, viability, safety, efficacy, dosing,
and social acceptance of cannabinoids or psychedelics; |
| ● | the
expensive, time-consuming, and uncertain nature of clinical trials, which are susceptible
to change, delays, termination, and differing interpretations; |
| ● | the
ability to establish that potential products are efficacious or safe in preclinical or clinical
trials; |
| ● | the
fact that our current and future preclinical and clinical studies may be conducted outside
the United States, and the United States Food and Drug Administration may not accept data
from such studies to support any new drug applications we may submit after completing the
applicable developmental and regulatory prerequisites; |
| ● | our
ability to effectively and efficiently build, maintain and legally protect our molecular
derivatives library so that it can be an essential building block from which those in the
biotech industry can develop new patented products; |
| ● | our
ability to establish or maintain collaborations on the development of therapeutic candidates; |
| ● | our
ability to obtain appropriate or necessary governmental approvals to market potential products; |
| ● | our
ability to manufacture product candidates on a commercial scale or in collaborations with
third parties; |
| ● | our
significant and increasing liquidity needs and potential requirements for additional funding; |
| ● | our
ability to obtain future funding for developing products and working capital and to obtain
such funding on commercially reasonable terms; |
| ● | legislative
changes related to and affecting the healthcare system, including, without limitation, changes
and proposed changes to the Patient Protection and Affordable Care Act; |
| ● | the
intense competition we face, often from companies with greater resources and experience than
us; |
| ● | our
ability to retain key executives and scientists; |
| ● | the
ability to secure and enforce legal rights related to our products, including intellectual
property rights and patent protection; |
| ● | political,
economic, and military instability in Israel which may impede our development programs; |
| ● | our
success at managing the risks involved in the foregoing; and |
| ● | the
risk of loss in excess of insurance limitations on funds help in U.S Banking Institutions. |
For
a more detailed discussion of these and other factors that may affect our business and that could cause the actual results to differ
materially from those projected in these forward-looking statements, see the risk factors and uncertainties set forth in Part II, Item
1A of this Form 10-Q and Part I, Item 1A of the Annual Report. Any one or more of these uncertainties, risks and other influences could
materially affect our results of operations and whether forward-looking statements made by us ultimately prove to be accurate. We undertake
no obligation to publicly update or revise any forward-looking statements, whether from new information, future events or otherwise,
except as required by law.
Business
Overview
We
are a biotechnology company dedicated to the development of novel neuroplastogenic small-molecule therapeutics for the treatment of depression,
anxiety, and addiction disorders. Leveraging its unique discovery and development platform, The Psybrary™, Enveric has created
a robust intellectual property portfolio of New Chemical Entities for specific mental health indications. Enveric’s lead program,
the EVM201 Series, comprises next generation synthetic prodrugs of the active metabolite, psilocin. Enveric is developing the first product
from the EVM201 Series – EB-373 – for the treatment of psychiatric disorders. Enveric is also advancing its second program,
the EVM301 Series, expected to offer a first-in-class, new approach to the treatment of difficult-to-address mental health disorders,
mediated by the promotion of neuroplasticity without also inducing hallucinations in the patient.
Psychedelics
Following
our amalgamation with MagicMed completed in September 2021 (the “Amalgamation”), we have continued to pursue the development
of MagicMed’s proprietary Psychedelic Derivatives library, the Psybrary™ which we believe will help us to identify and develop
the right drug candidates needed to address mental health challenges, including cancer-related distress. We synthesize novel versions
of classic psychedelics, such as psilocybin, N-dimethyltryptamine (DMT), mescaline and MDMA, using a mixture of chemistry and synthetic
biology, resulting in the expansion of the Psybrary™, which includes 15 patent families with over a million potential variations
and hundreds of synthesized molecules. Within the Psybrary™ we have three different types of molecules, Generation 1 (classic psychedelics),
Generation 2 (pro-drugs), and Generation 3 (new chemical entities). The Company is working to add novel psychedelic molecular compounds
and Psychedelic Derivatives on a regular basis through our work at Enveric Labs in Calgary, Alberta, Canada, where we have a team of
PhD scientists with expertise in synthetic biology and chemistry. To date we have created over 500 molecules that are housed in the Psybrary.
We
screen newly synthesized molecules in the Psybrary™ through PsyAI™, a proprietary AI tool. Leveraging AI systems is expected
to reduce the time and cost of pre-clinical, clinical, and commercial development. We believe it streamlines pharmaceutical design by
predicting ideal binding structures of molecules, manufacturing capabilities, and pharmacological effects to help determine ideal drug
candidates, tailored to each indication. Each of these molecules that we believe are patentable can then be further screened to see how
changes to its makeup alter its effects in order to synthesize additional new molecules. New compounds of sufficient purity are undergoing
pharmacological screening, including non-clinical (receptors/cell lines), preclinical (animal), and ultimately clinical (human) evaluations.
We intend to utilize our Psybrary™ and the AI tool to categorize and characterize the Psybrary™ substituents to focus on
bringing more psychedelics-inspired molecules from discovery to the clinical phase.
Cannabinoids
We
aim to advance a pipeline of novel cannabinoid combination therapies for the side effects of cancer treatments, such as chemotherapy
and radiotherapy.
We
intend to bring together leading oncology clinicians, researchers, academic and industry partners to develop both external proprietary
products and a robust internal pipeline of product candidates aimed at improving quality of life and outcomes for cancer patients. We
intend to evaluate options to out-license our proprietary technology as it moves along the regulatory pathway.
In
developing our product candidates, we intend to focus on cannabinoids derived from non-hemp botanical sources, and synthetic materials
containing no tetrahydrocannabinol (“THC”) in order to comply with U.S. federal regulations. Of the potential cannabinoids
to be used in therapeutic formulations, THC, which is responsible for the psychoactive properties of marijuana, can result in undesirable
mood effects. Selected cannabidiol (CBD) and cannabigerol (CBG) candidates, on the other hand, have amounts of THC well below 0.1% and
are not psychotropic and therefore more attractive candidates for translation into therapeutic practice. Drugs with less than 0.1% THC
have a history, when approved as drugs by the Food and Drug Administration “FDA”, of being able to be rescheduled by DEA
from Schedule I to Schedule V, as in the case of Epidiolex and Marinol. In the future, we may utilize cannabinoids that are derived from
cannabis plants, which may contain higher amounts of THC; however, we only intend to do so in jurisdictions where THC is legal. However,
synthetic THC is a Schedule I controlled substance; so, the use of any APIs (Active Pharmaceutical Ingredients) containing synthetic
THC (or naturally derived THC in concentrations greater than 0.3%) may increase regulatory scrutiny and require additional expenses and
authorizations. All current and future product candidates that we are developing or may develop will be tested for safety and efficacy
under an IND application and subject to the FDA pre-market approval process for new drugs.
While
we continue to pursue the development of our cannabinoid-based product candidates, our principal focus is on the development of psychedelic-based
treatments.
On
May 11, 2022, the Company announced plans to transfer and spin-off its cannabinoid clinical development pipeline assets (the “Spin-Off”)
to Akos Biosciences, Inc. (formerly known as Acanna Therapeutics, Inc.), a majority owned subsidiary of the Company (“Akos”).
In connection with the Spin-Off, the Company would transfer its cannabinoid clinical development pipeline assets to Akos, while retaining
its psychedelics clinical development pipeline assets. The Spin-Off was subject to various conditions, including Akos meeting the qualifications
for listing on the Nasdaq Stock Market, and if successful, would result in two standalone public companies.
In
May 2023, pursuant to the Akos Series A Preferred Certificate of Designations, the holders of the Akos Series A Preferred Stock exercised
their Put Right requiring Akos to redeem all of the outstanding shares of Akos Series A Preferred Stock for $1,000 per share, plus
accrued but unpaid dividends of approximately $52,000 for a total redemption amount of approximately $1,052,000. The Company completed
the redemption May 19, 2023. The Company now plans to engage with strategic advisors to identify and pursue alternative routes to capture
value from the cannabinoid assets.
Recent
Developments
Australian
Subsidiary
On
March 21, 2023, the Company established Enveric Therapeutics, Pty. Ltd. (“Enveric Therapeutics”), an Australia-based subsidiary,
to support the Company’s plans to advance its EVM201 Series towards the clinic. Enveric Therapeutics will oversee the Company’s
preclinical, clinical, and regulatory activities in Australia, including ongoing interactions with the local Human Research Ethics Committees
(HREC) and the Therapeutic Goods Administration (“TGA”), Australia’s regulatory authority.
On
March 23, 2023, the Company issued a press release announcing the selection of Australian CRO, Avance Clinical, in preparation for Phase
1 Study of EB-373, the Company’s lead candidate targeting the treatment of anxiety disorders. Under the agreement, Avance Clinical
will manage the Phase 1 clinical trial of EB-373 in coordination with the Company’s newly established Australian subsidiary, Enveric
Therapeutics Pty, Ltd. The Phase 1 clinical trial is designed as a multi-cohort, dose-ascending study to measure the safety and tolerability
of EB-373. EB-373, a next-generation proprietary psilocin prodrug, has been recognized as a New Chemical Entity (NCE) by Australia’s
TGA and is currently in preclinical development targeting the treatment of anxiety disorder. The total cost of the Avance Clinical contract
is approximately 3,000,000 AUD, which translates to approximately $2,000,000 as of September 30, 2023. As of September 30, 2023, the
Company has paid $950,997 of the Avance Clinical contract costs and has $549,713 recorded as prepaid assets. For the three and nine months
ended September 30, 2023, the Company has expensed $157,117 and $401,284 in research and development expenses, respectively.
Reduction
in Force/Restructuring
In
May 2023, the Company entered into a cost reduction plan, including a reduction in force of approximately 35% of its full-time employees
to streamline its operations and conserve cash resources. Additionally, contracts with seven consultants that were focused on the Akos
cannabinoid spin-out were terminated. The Company recognized severance charges of approximately $453,059 through September 30, 2023.
The plan included a focus on progressing the Company’s existing non-cannabinoid pipeline while reducing the rate of spend and managing
cash flow. As of September 30, 2023, the Company has completed the reduction in force, with such severance expenses recorded in salaries
and wages and legal accounts.
On
June 16, 2023, the Company entered into a separation agreement with Avani Kanubaddi, the Company’s President and Chief Operating
Officer (the “Kanubaddi Separation Agreement”). In accordance with the Kanubaddi Separation Agreement, Mr. Kanubaddi’s
outstanding RSUs will retain their vesting conditions. Mr. Kanubaddi’s 2023 salary and benefits of $550,974 was accrued and will
be paid out in twelve equal monthly installments beginning in July 2023. Upon termination, any unvested time-based RSU’s became
fully vested. The Company accelerated expense recognized related to these shares that vested upon termination of $231,273. Of the 11,278
market performance-based RSUs, 3,759 will continue to be subject to the original terms and conditions of Mr. Kanubaddi’s employment
agreement and the remainder were forfeited.
Equity
Distribution Agreement
On
September 1, 2023, the Company entered into the Distribution Agreement, with Canaccord, pursuant to which the Company may offer and sell
from time to time, through Canaccord as sales agent and/or principal, shares of common stock of the Company, par value $0.01 per share
having an aggregate offering price of up to $10.0 million. Due to the offering limitations applicable to the Company and in accordance
with the terms of the Distribution Agreement, the Company may offer Common Stock having an aggregate gross sales price of up to $2,392,514
pursuant to the prospectus supplement dated September 1, 2023 (the “Prospectus Supplement”). Subject to the terms and conditions
of the Distribution Agreement, Canaccord may sell the Common Stock by any method permitted by law deemed to be an “at-the-market
offering”. The Company will pay Canaccord a commission equal to 3.0% of the gross sales price of the Common Stock sold through
Canaccord under the Distribution Agreement and has also agreed to reimburse Canaccord for certain expenses. The Company may also sell
Common Stock to Canaccord as principal for Canaccord’s own account at a price agreed upon at the time of sale. Any sale of Common
Stock to Canaccord as principal would be pursuant to the terms of a separate terms agreement between the Company and Canaccord.
During
the three and nine months ended September 30, 2023, the Company has issued no shares of common stock through the Distribution Agreement.
Results
of Operations
The
following table sets forth information comparing the components of net loss for the three months ended September 30, 2023, and 2022:
| |
For
the Three Months Ended September 30, | |
| |
2023 | | |
2022 | |
Operating expenses | |
| | | |
| | |
General and administrative | |
$ | 2,010,349 | | |
$ | 3,514,547 | |
Research and development | |
| 1,351,750 | | |
| 2,055,656 | |
Depreciation and amortization | |
| 86,296 | | |
| 86,646 | |
Total operating expenses | |
| 3,448,395 | | |
| 5,656,849 | |
| |
| | | |
| | |
Loss from operations | |
| (3,448,395 | ) | |
| (5,656,849 | ) |
| |
| | | |
| | |
Other income (expense) | |
| | | |
| | |
Change in fair value of warrant liabilities | |
| 67,822 | | |
| 1,599,623 | |
Change in fair value of investment option liability | |
| 562,715 | | |
| 1,809,622 | |
Change in fair value of derivative liability | |
| — | | |
| (231,000 | ) |
Interest income (expense) | |
| 2,237 | | |
| (308 | ) |
Total other income | |
| 632,774 | | |
| 3,177,937 | |
Net loss before income taxes | |
$ | (2,815,621 | ) | |
$ | (2,478,912 | ) |
| |
| | | |
| | |
Income tax expense | |
| (6,595 | ) | |
| — | |
| |
| | | |
| | |
Net loss | |
$ | (2,822,216 | ) | |
$ | (2,478,912 | ) |
General
and Administrative Expenses
Our
general and administrative expenses decreased to $2,010,349 for the three months ended September 30, 2023 from $3,514,547 for the three
months ended September 30, 2022, a decrease of $1,504,198, or 43%. This change was primarily driven by a decrease in transaction expenses
from liability classified equity offerings of $704,094, stock based compensation of $329,178, directors and officer insurance of $252,097,
and marketing of $201,862.
Research
and Development Expenses
Our
research and development expense for the three months ended September 30, 2023 was $1,351,750 as compared to $2,055,656 for the three
months ended September 30, 2022 with a decrease of $703,906, or approximately 34%. This change was primarily driven by the change in
strategy and cost reduction plan resulting in a decrease of payroll and consulting fees of $804,023, scientific advisory board fees of
$41,198 and product development expense of $151,989, offset by the increase of the Avance clinical contract of $290,797.
Depreciation
and Amortization Expense
Depreciation
and amortization expense for the three months ended September 30, 2023 was $86,296 as compared to $86,646 for the three months ended
September 30, 2022, with a decrease of $350. Depreciation and amortization expense was substantially similar for the three months ended
September 30, 2023 compared with the three months ended September 30, 2022.
Change
in Fair Value of Warrant Liabilities
Change
in fair value of warrant liabilities for the three months ended September 30, 2023 resulted in income of $67,822 as compared to income
of $1,599,623 for the three months ended September 30, 2022. The change in fair value of warrant liabilities is significantly influenced
by the change in the closing price of Common Stock at the end of each period, as compared to the closing price of Common Stock at the
beginning of each period with a strong inverse relationship between changes in fair value of warrant liabilities and the trading price
of Common Stock. The Company’s stock price was $2.38 as of September 30, 2023, $3.37 as of June 30, 2023, $4.22 as of September
30, 2022 and $10.70 as of June 30, 2022. The stock price of the Company decreased approximately 29% during the three months ended September
30, 2023 compared to a decrease of approximately 61% during the three months ended September 30, 2022. The significant percentage change
in the Company’s stock price during the three months ended September 30, 2023 compared to the three months ended September 30,
2022, resulted in the increase to the change in fair value of warrant liabilities.
Change
in Fair Value of Investment Option Liability
Change
in fair value of investment option liability for the three months ended September 30, 2023 resulted in income of $562,715, as
compared to $1,809,622 during the three months ended September 30, 2022. The change in fair value is due to the significant decrease
in the Company’s stock price for the three months ended September 30, 2023. The Company’s stock price was $2.38 on
September 30, 2023 and $3.37 on June 30, 2023, a decrease of approximately 29% during that time compared to a decrease of
approximately 33% during the three months ended September 30, 2022.
Change
in Fair Value of Derivative Liability
The
Company’s change in fair value of derivative liability expense was $231,000 for the three months ended September 30, 2022, compared
to $0 for the three months ended September 30, 2023 due to redemption of the redeemable stock in May 2023 and therefore no probability
of occurrence of the Akos spin-off as of September 30, 2023 as compared to June 30, 2023.
The
following table sets forth information comparing the components of net loss for the nine months ended September 30, 2023 and 2022:
| |
For the Nine Months Ended September 30, | |
| |
2023 | | |
2022 | |
Operating expenses | |
| | | |
| | |
General and administrative | |
$ | 7,921,340 | | |
$ | 8,783,619 | |
Research and development | |
| 5,883,440 | | |
| 6,134,421 | |
Depreciation and amortization | |
| 259,300 | | |
| 241,413 | |
Total operating expenses | |
| 14,064,080 | | |
| 15,159,453 | |
| |
| | | |
| | |
Loss from operations | |
| (14,064,080 | ) | |
| (15,159,453 | ) |
| |
| | | |
| | |
Other income (expense) | |
| | | |
| | |
Change in fair value of warrant liabilities | |
| (115,342 | ) | |
| 3,845,514 | |
Change in fair value of investment option liability | |
| (399,921 | ) | |
| 1,809,622 | |
Change in fair value of derivative liability | |
| 727,000 | | |
| (284,000 | ) |
Interest income (expense) | |
| 3,142 | | |
| (5,114 | ) |
Total other income | |
| 214,879 | | |
| 5,366,022 | |
| |
| | | |
| | |
Net loss before income taxes | |
$ | (13,849,201 | ) | |
$ | (9,793,431 | ) |
Income tax expense | |
| (6,595 | ) | |
| — | |
Net loss | |
$ | (13,855,796 | ) | |
$ | (9,793,431 | ) |
General
and Administrative Expenses
Our
general and administrative expenses decreased to $7,921,340 for the nine months ended September 30, 2023 from $8,783,619 for the nine
months ended September 30, 2022, a decrease of $862,279, or 10%. This change was primarily driven by a decrease in transaction expenses
from liability classified equity offerings of $823,970, directors and officers insurance of $780,797, stock based compensation of $202,908
and marketing of $274,814, partially offset by an increase in consulting fees of $626,382, accounting fees of $310,797 and franchise
taxes of $307,644.
Research
and Development Expenses
Our
research and development expense for the nine months ended September 30, 2023 was $5,883,440 as compared to $6,134,421 for the nine months
ended September 30, 2022 with a decrease of $250,981, or approximately 4%. This change was primarily driven by increase of the Avance
clinical contract of $646,029 and product development of $141,085 offset by payroll and consulting fees of $1,021,851 for the change
in strategy and reduction in workforce as part of the cost reduction plan.
Depreciation
and Amortization Expense
Depreciation
and amortization expense for the nine months ended September 30, 2023 was $259,300 as compared to $241,413 for the nine months ended
September 30, 2022, with an increase of $17,887, or approximately 7%. This increase is due to fixed asset additions during the nine months
ended September 30, 2022 which only incurred partial depreciation, compared to a full nine months’ of depreciation during the nine
months ended September 30, 2023.
Change
in Fair Value of Warrant Liabilities
Change
in fair value of warrant liabilities the nine months ended September 30, 2023 resulted in expense of $115,342 as compared to income of
$3,845,514 for the nine months ended September 30, 2022. The change in fair value of warrant liabilities is significantly influenced
by the change in the closing price of Common Stock at the end of each period, as compared to the closing price of Common Stock at the
beginning of each period with a strong inverse relationship between changes in fair value of warrant liabilities and the trading price
of Common Stock. The Company’s stock price per share was $2.38 as of September 30, 2023, $2.08 as of December 31, 2022, $4.22 as
of September 30, 2022 and $46.50 as of December 31, 2021. The stock price of the Company increased approximately 14% during the nine
months ended September 30, 2023 compared to a decrease of approximately 91% during the nine months ended September 30, 2022. The significant
percentage change in the Company’s stock price during the nine months ended September 30, 2023 compared to the nine months ended
September 30, 2022, resulted in the increase to the change in fair value of warrant liabilities.
Change
in Fair Value of Investment Option Liability
Change
in fair value of investment option liability during the nine months ended September 30, 2023 resulted in expense of $399,921, as compared
to $1,809,622 during the nine months ended September 30, 2022. The change in fair value is due to the significant increase in the Company’s
stock price the nine months ended September 30, 2023. The Company’s stock price per share was $2.08 on December 31, 2022 and $2.38
on September 30, 2023, an increase of approximately 14% during that time, compared to a decrease of approximately 33% during the nine
months ended September 30, 2022. The significant percentage change in the Company’s stock price during the nine months ended September
30, 2023 compared to the nine months ended September 30, 2022, resulted in the increase to the change in fair value of warrant liabilities.
Change
in Fair Value of Derivative Liability
The
Company’s change in fair value of derivative liability was expense of $284,000 for the nine months ended September 30, 2022 compared
to income of $727,000 for the nine months ended September 30, 2023, due primarily to the May 2023 redemption which ceased the probability
of occurrence of the Akos spin-off and Akos Series A Preferred Stock redemption as of September 30, 2023 as compared to December 31,
2022.
Going
Concern, Liquidity and Capital Resources
The
Company has incurred a loss since inception resulting in an accumulated deficit of $93,063,582 as of September 30, 2023 and further losses
are anticipated in the development of its business. Further, the Company had operating cash outflows of $12,343,363 for the nine months
ended September 30, 2023. For the nine months ended September 30, 2023, the Company had a loss from operations of $14,064,080. Since
inception, being a research and development company, the Company has not yet generated revenue and the Company has incurred continuing
losses from its operations. The Company’s operations have been funded principally through the issuance of debt and equity. These
factors raise substantial doubt about the Company’s ability to continue as a going concern for a period of one year from the issuance
of these financial statements.
In
assessing the Company’s ability to continue as a going concern, the Company monitors and analyzes its cash and its ability to generate
sufficient cash flow in the future to support its operating and capital expenditure commitments. At September 30, 2023, the Company had
cash of $4,266,568 and working capital of $1,643,374. The Company’s current cash on hand is insufficient enough to satisfy its
operating cash needs for the 12 months following the filing of this Quarterly Report on Form 10-Q. These conditions raise substantial
doubt regarding the Company’s ability to continue as a going concern for a period of one year after the date the financial statements
are issued. Management’s plan to alleviate the conditions that raise substantial doubt include reducing the Company’s rate
of spend, managing its cash flow, advancing its programs, and raising additional working capital through public or private equity or
debt financings or other sources, which has included the Equity Distribution Agreement with Canaccord for proceeds of up to $2.4 million
and the Purchase Agreement with Lincoln Park, which may include collaborations with third parties as well as disciplined cash spending,
to increase the Company’s cash runway. Adequate additional financing may not be available to the Company on acceptable terms, or
at all. Should the Company be unable to raise sufficient additional capital, the Company may be required to undertake cost-cutting measures
including delaying or discontinuing certain operating activities.
In
May 2023, the Company entered into a cost reduction plan, including a reduction in force of approximately 35% of its full-time employees
to streamline its operations and conserve cash resources. Additionally, contracts with seven consultants that were focused on the Akos
cannabinoid spin-out will be terminated. Additionally, on June 16, 2023, the Company entered into the Kanubaddi Separation Agreement
with Avani Kanubaddi, the Company’s President and Chief Operating Officer. In accordance with the Kanubaddi Separation Agreement,
Mr. Kanubaddi’s outstanding RSUs will retain their vesting conditions. Mr. Kanubaddi’s 2023 salary and benefits was accrued
and will be paid out in twelve equal monthly installments beginning in July 2023. The Company recognized severance charges of approximately
$1,004,033 through September 30, 2023, with $396,431 of these charges paid as of September 30, 2023. The plan included a focus on progressing
the Company’s existing non-cannabinoid pipeline while reducing the rate of spend and managing cash flow. As of September 30, 2023,
the Company has completed the reduction in force, with such severance expenses recorded in salaries and wages and legal accounts.
As
a result of these factors, management has concluded that there is substantial doubt about the Company’s ability to continue as
a going concern for a period of one year after the date of the financial statements are issued. The Company’s condensed consolidated
financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Cash
Flows
Since
inception, we have primarily used our available cash to fund our product development and operations expenditures.
Cash
Flows for the Nine Months Ended September 30, 2023 and 2022
The
following table sets forth a summary of cash flows for the years presented:
| |
For the Nine Months Ended September 30, | |
| |
2023 | | |
2022 | |
Net cash used in operating activities | |
$ | (12,343,363 | ) | |
$ | (13,684,606 | ) |
Net cash provided by (used in) investing activities | |
| 11,705 | | |
| (577,972 | ) |
Net cash (used in) provided by financing activities | |
| (1,157,057 | ) | |
| 18,180,138 | |
Effect of foreign exchange rate on cash | |
| 31,399 | | |
| (72,554 | ) |
Net (decrease) increase in cash | |
$ | (13,457,316 | ) | |
$ | 3,845,006 | |
Operating
Activities
Net
cash used in operating activities was $12,343,363 during the nine months ended September 30, 2023, which consisted primarily of a net
loss adjusted for non-cash items of $11,962,774, an increase in prepaid expenses of $746,033, and an increase in accounts payable and
accrued liabilities of $429,688.
Net
cash used in operating activities was $13,684,606 during the nine months ended September 30, 2022, which consisted primarily of a net
loss adjusted for non-cash items of $12,728,490, increase in prepaid expenses and other current assets of $758,419, and a decrease in
accounts payable and accrued liabilities of $106,675.
Investing
Activities
Net
cash provided by investing activities was $11,705 during the nine months ended September 30, 2023, which consisted of the purchase of
property and equipment, offset by proceeds from sale of property and equipment.
Net
cash used in investing activities was $577,972 during the nine months ended September 30, 2022, which consisted of the purchase of property
and equipment.
Financing
Activities
Net
cash used in financing activities was $1,157,057 during the nine months ended September 30, 2023, which consisted of the redemption of
redeemable non-controlling interest and payment of deferred offering costs.
Net
cash provided by financing activities was $18,180,138 during the nine months ended September 30, 2022, which consisted of $17,222,100
in proceeds from the sale of common stock and warrants and $958,038 in proceeds from the sale of redeemable non-controlling interest.
Critical
Accounting Policies and Significant Judgments and Estimates
The
Company’s accounting policies are fundamental to understanding its management’s discussion and analysis. The Company’s
significant accounting policies are presented in Note 2 to its financial statements for the year ended December 31, 2022, and included
in the Annual Report. The Company’s financial statements have been prepared in accordance with accounting principles generally
accepted in the United States of America (“U.S. GAAP”) for interim financial information. Accordingly, they do not include
all of the information and notes required by U.S. GAAP. However, in the opinion of the management of the Company, all adjustments necessary
for a fair presentation of the financial position and operating results have been included in the Company’s unaudited condensed
consolidated financial statements.
Item
3. Quantitative and Qualitative Disclosures About Market Risk
From
inception through September 30, 2023, the Company’s reporting currency is the United States dollar while the functional currency
of certain of the Company’s subsidiaries were the Canadian dollar and Australian dollar. For the reporting periods ended September
30, 2023 and September 30, 2022, the Company engaged in a number of transactions denominated in Canadian dollars and Australian dollars.
As a result, the Company is subject to exposure from changes in the exchange rates of the Canadian dollar and Australian dollar against
the U.S. dollar.
The
Company has not entered into any financial derivative instruments that expose it to material market risk, including any instruments designed
to hedge the impact of foreign currency exposures. The Company may, however, hedge such exposure to foreign currency exchange fluctuations
in the future.
Item
4. Controls and Procedures
Evaluation
of Disclosure Controls and Procedures
We
maintain disclosure controls and procedures designed to ensure that the information we are required to disclose in reports we file or
submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified under the rules and
forms of the SEC. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that such
information is accumulated and communicated to our management, including our Chief Executive Officer and our Chief Financial Officer,
as appropriate, to allow timely decisions regarding required disclosures. A material weakness is a deficiency, or combination of deficiencies,
in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our annual
or interim financial statements will not be prevented or detected on a timely basis. The matters that management identified in our Annual
Report for the year ended December 31, 2022, continued to exist and were still considered material weaknesses in our internal control
over financial reporting at September 30, 2023.
As
required by paragraph (b) of Rules 13a-15 and 15d-15 under the Exchange Act, our Chief Executive Officer (our principal executive) and
Chief Financial Officer (our principal financial officer and principal accounting officer) carried out an evaluation of the effectiveness
of the design and operation of our disclosure controls and procedures as of September 30, 2023. Based on this evaluation, and in light
of the material weaknesses found in our internal controls over financial reporting, our Chief Executive Officer and Chief Financial Officer
concluded that our disclosure controls and procedures (as defined in paragraph (e) of Rules 13a-15 and 15d-15 under the Exchange Act)
were not effective as of September 30, 2023.
Management’s
Remediation Plan
As
previously discussed in our Annual Report for the year ended December 31, 2022, management had concluded that our internal control over
financial reporting was not effective as of December 31, 2022, because management identified inadequate segregation of duties to ensure
the processing, review, and authorization of all transactions, including non-routine transactions resulting in deficiencies, which, in
aggregate, amounted to a material weakness in the Company’s internal control over financial reporting.
As
of September 30, 2023, there were control deficiencies that constituted a material weakness in our internal control over financial reporting.
Management has taken, and is taking steps to strengthen our internal control over financial reporting: we have conducted evaluation of
the material weakness to determine the appropriate remedy and have established procedures for documenting disclosures and disclosure
controls.
While
we have taken certain actions to address the material weaknesses identified, additional measures may be necessary as we work to improve
the overall effectiveness of our internal controls over financial reporting.
Changes
in Internal Control over Financial Reporting
Other
than the changes discussed above in the Remediation Plan, there have been no other changes in our internal controls over financial reporting
(as defined in Rule 13a-15(f) and 15d-(f) of the Exchange Act) that occurred during quarter ending September 30, 2023, 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, 2023, as amended on June 9, 2023 and quarterly reports on Form 10-Q as
filed with the SEC on May 15, 2023 and August 11, 2023. 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, 2023, as amended on June
9, 2023 and quarterly reports on Form 10-Q as filed with the SEC on May 15, 2023 and August 11, 2023.
Item
2. Unregistered Sales of Equity Securities and Use of Proceeds
None.
Item
3. Defaults Upon Senior Securities
None.
Item
4. Mine Safety Disclosures
Not
applicable.
Item
5. Other Information
In
May 2023, pursuant to the Akos Series A Preferred Certificate of Designations, the holders of the Akos Series A Preferred Stock exercised
the Put Right requiring Akos to force redemption of all of the Akos Series A Preferred Stock for $1,000 per share, plus accrued
but unpaid dividends of approximately $50,000 for a total of approximately $1,052,057. The Company has 20 days following the receipt
of the Put Exercise Notice to make the payment and made payment on May 19, 2023.
The
Company, Akos, and the Akos Investor intend to terminate the Akos Purchase Agreement in connection with the planned Spin-Off and that
certain registration rights agreement in connection with the Akos Private Placement.
In
May 2023, the Company entered into a cost reduction plan, including a reduction in force of approximately 35% of its full-time employees
to streamline its operations and conserve cash resources. Additionally, contracts with seven consultants that were focused on the Akos
cannabinoid spin-out will be terminated. The Company recognized severance charges of approximately $1,004,033 through September 30, 2023.
The plan included a focus on progressing the Company’s existing non-cannabinoid pipeline while reducing the rate of spend and managing
cash flow. As of September 30, 2023, the Company has completed the reduction in force, with such severance expenses recorded in salaries
and wages and legal accounts.
Item
6. Exhibits
INDEX
TO EXHIBITS
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned, thereunto duly authorized.
|
ENVERIC
BIOSCIENCES, INC |
November
13, 2023 |
|
|
|
By: |
/s/
Dr. Joseph Tucker |
|
|
Dr.
Joseph Tucker |
|
|
Chief
Executive Officer |
|
|
(Principal
Executive Officer) |
|
|
|
November
13, 2023 |
|
|
|
By: |
/s/
Kevin Coveney |
|
|
Kevin
Coveney |
|
|
Chief
Financial Officer |
|
|
(Principal
Financial and Accounting Officer) |
EXHIBIT
31.1
CERTIFICATION PURSUANT to
Exchange Act Rule 13a-14(a)/15d-14(a) as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
I, Dr. Joseph
Tucker, Chief Executive Officer of Enveric Biosciences, Inc., certify that:
1. I have reviewed this report on Form 10-Q of Enveric Biosciences, Inc. (the “registrant”);
2. Based
on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make
the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered
by this report;
3. Based
on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects
the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The
registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting
(as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a) Designed
such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure
that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those
entities, particularly during the period in which this report is being prepared;
b) Designed
such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision,
to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external
purposes in accordance with generally accepted accounting principles;
c) Evaluated
the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the
effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;
and
d) Disclosed
in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s
most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected,
or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5. The
registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial
reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing
the equivalent functions):
a) All
significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably
likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b) Any
fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal
control over financial reporting.
Date: November 13, 2023 |
/s/ Dr. Joseph Tucker |
|
Dr. Joseph Tucker |
|
Chief Executive Officer |
EXHIBIT
31.2
CERTIFICATION
PURSUANT to Exchange Act Rule 13a-14(a)/15d-14(a) as Adopted Pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002
I,
Kevin Coveney, Chief Financial Officer of Enveric Biosciences, Inc., certify that:
1. I have reviewed this report on Form 10-Q of Enveric Biosciences, Inc. (the “registrant”);
2. Based
on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make
the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered
by this report;
3. Based
on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects
the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The
registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act
Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a) Designed
such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure
that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those
entities, particularly during the period in which this report is being prepared;
b) Designed
such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision,
to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external
purposes in accordance with generally accepted accounting principles;
c) Evaluated
the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the
effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;
and
d) Disclosed
in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s
most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected,
or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5. The
registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial
reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing
the equivalent functions):
a) All
significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably
likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b) Any
fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal
control over financial reporting.
Date:
November 13, 2023 |
/s/
Kevin Coveney |
|
Kevin
Coveney |
|
Chief
Financial Officer |
EXHIBIT
32.1
CERTIFICATION
PURSUANT TO 18 U.S.C. SECTION 1350,
AS
ADOPTED PURSUANT TO
SECTION
906 OF THE SARBANES-OXLEY ACT OF 2002
In
connection with the Quarterly Report of Enveric Biosciences, Inc. (the “Issuer”) on Form 10-Q for the period ended September
30, 2023, as filed with the Securities and Exchange Commission on the date hereof (the “Form 10-Q”), each of the undersigned,
in the capacities and on the dates indicated below, hereby certifies pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section
906 of the Sarbanes-Oxley Act of 2002, that:
(i)
the Form 10-Q fully complies with the requirements of Section 13(a) or Section 15(d) of the Securities Exchange Act of 1934;
and
(ii)
the information contained in the Form 10-Q fairly presents, in all material respects, the financial condition and results of
operations of the Issuer.
Dated:
November 13, 2023
|
By:
|
/s/
Dr. Joseph Tucker |
|
|
Dr.
Joseph Tucker |
|
|
Chief
Executive Officer |
|
|
(Principal
Executive Officer) |
|
|
|
|
By:
|
/s/
Kevin Coveney |
|
|
Kevin
Coveney |
|
|
Chief
Financial Officer |
|
|
(Principal
Financial and Accounting Officer) |
v3.23.3
Cover - shares
|
9 Months Ended |
|
Sep. 30, 2023 |
Nov. 09, 2023 |
Cover [Abstract] |
|
|
Document Type |
10-Q
|
|
Amendment Flag |
false
|
|
Document Quarterly Report |
true
|
|
Document Transition Report |
false
|
|
Document Period End Date |
Sep. 30, 2023
|
|
Document Fiscal Period Focus |
Q3
|
|
Document Fiscal Year Focus |
2023
|
|
Current Fiscal Year End Date |
--12-31
|
|
Entity File Number |
001-38286
|
|
Entity Registrant Name |
ENVERIC
BIOSCIENCES, INC.
|
|
Entity Central Index Key |
0000890821
|
|
Entity Tax Identification Number |
95-4484725
|
|
Entity Incorporation, State or Country Code |
DE
|
|
Entity Address, Address Line One |
4851
Tamiami Trail N
|
|
Entity Address, Address Line Two |
Suite 200
|
|
Entity Address, City or Town |
Naples
|
|
Entity Address, State or Province |
FL
|
|
Entity Address, Postal Zip Code |
34103
|
|
City Area Code |
(239)
|
|
Local Phone Number |
302-1707
|
|
Title of 12(b) Security |
Common
Stock, $0.01 par value per share
|
|
Trading Symbol |
ENVB
|
|
Security Exchange Name |
NASDAQ
|
|
Entity Current Reporting Status |
Yes
|
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Yes
|
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|
|
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true
|
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v3.23.3
Condensed Consolidated Balance Sheets - USD ($)
|
Sep. 30, 2023 |
Dec. 31, 2022 |
Current assets: |
|
|
Cash |
$ 4,266,568
|
$ 17,723,884
|
Prepaid expenses and other current assets |
1,560,354
|
708,053
|
Total current assets |
5,826,922
|
18,431,937
|
Other assets: |
|
|
Property and equipment, net |
539,152
|
677,485
|
Right-of-use operating lease asset |
|
63,817
|
Intangible assets, net |
253,120
|
379,686
|
Total other assets |
792,272
|
1,120,988
|
Total assets |
6,619,194
|
19,552,925
|
Current liabilities: |
|
|
Accounts payable |
1,098,233
|
463,275
|
Accrued liabilities |
1,533,829
|
1,705,655
|
Current portion of right-of-use operating lease obligation |
|
63,820
|
Investment option liability |
1,250,929
|
851,008
|
Warrant liability |
300,557
|
185,215
|
Derivative liability |
|
727,000
|
Total current liabilities |
4,183,548
|
3,995,973
|
Commitments and contingencies (Note 9) |
|
|
Mezzanine equity |
|
|
Series C redeemable preferred stock, $0.01 par value, 100,000 shares authorized, and 0 shares issued and outstanding as of September 30, 2023 and December 31, 2022 |
|
|
Redeemable non-controlling interest |
|
885,028
|
Total mezzanine equity |
|
885,028
|
Shareholders’ equity |
|
|
Preferred stock, $0.01 par value, 20,000,000 shares authorized; Series B preferred stock, $0.01 par value, 3,600,000 shares authorized, 0 shares issued and outstanding as of September 30, 2023 and December 31, 2022 |
|
|
Common stock, $0.01 par value, 100,000,000 shares authorized, 2,181,912 and 2,078,271 shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively |
21,818
|
20,782
|
Additional paid-in capital |
96,013,029
|
94,395,662
|
Accumulated deficit |
(93,063,582)
|
(79,207,786)
|
Accumulated other comprehensive loss |
(535,619)
|
(536,734)
|
Total shareholders’ equity |
2,435,646
|
14,671,924
|
Total liabilities, mezzanine equity, and shareholders’ equity |
$ 6,619,194
|
$ 19,552,925
|
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v3.23.3
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares
|
Sep. 30, 2023 |
Dec. 31, 2022 |
Preferred stock, par value |
$ 0.01
|
$ 0.01
|
Preferred stock, shares authorized |
20,000,000
|
20,000,000
|
Common stock, par value |
$ 0.01
|
$ 0.01
|
Common stock, shares authorized |
100,000,000
|
100,000,000
|
Common stock, shares issued |
2,181,912
|
2,078,271
|
Common stock, shares outstanding |
2,181,912
|
2,078,271
|
Series B Preferred Stock [Member] |
|
|
Preferred stock, par value |
$ 0.01
|
$ 0.01
|
Preferred stock, shares authorized |
3,600,000
|
3,600,000
|
Preferred stock, shares issued |
0
|
0
|
Preferred stock, shares outstanding |
0
|
0
|
Series C Redeemable Preferred Stock [Member] |
|
|
Temporary equity, par value |
$ 0.01
|
$ 0.01
|
Temporary equity, shares authorized |
100,000
|
100,000
|
Temporary equity, shares issued |
0
|
0
|
Temporary equity, shares outstanding |
0
|
0
|
X |
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v3.23.3
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($)
|
3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Operating expenses |
|
|
|
|
General and administrative |
$ 2,010,349
|
$ 3,514,547
|
$ 7,921,340
|
$ 8,783,619
|
Research and development |
1,351,750
|
2,055,656
|
5,883,440
|
6,134,421
|
Depreciation and amortization |
86,296
|
86,646
|
259,300
|
241,413
|
Total operating expenses |
3,448,395
|
5,656,849
|
14,064,080
|
15,159,453
|
Loss from operations |
(3,448,395)
|
(5,656,849)
|
(14,064,080)
|
(15,159,453)
|
Other income (expense) |
|
|
|
|
Change in fair value of warrant liabilities |
67,822
|
1,599,623
|
(115,342)
|
3,845,514
|
Change in fair value of investment option liability |
562,715
|
1,809,622
|
(399,921)
|
1,809,622
|
Change in fair value of derivative liability |
|
(231,000)
|
727,000
|
(284,000)
|
Interest income (expense) |
2,237
|
(308)
|
3,142
|
(5,114)
|
Total other income |
632,774
|
3,177,937
|
214,879
|
5,366,022
|
Net loss before income taxes |
(2,815,621)
|
(2,478,912)
|
(13,849,201)
|
(9,793,431)
|
Income tax expense |
(6,595)
|
|
(6,595)
|
|
Net loss |
(2,822,216)
|
(2,478,912)
|
(13,855,796)
|
(9,793,431)
|
Less preferred dividends attributable to non-controlling interest |
|
12,603
|
19,041
|
20,411
|
Less deemed dividends attributable to accretion of embedded derivative at redemption value |
|
110,991
|
147,988
|
184,985
|
Net loss attributable to shareholders |
(2,822,216)
|
(2,602,506)
|
(14,022,825)
|
(9,998,827)
|
Other comprehensive loss |
|
|
|
|
Foreign currency translation |
10,433
|
(417,390)
|
1,115
|
(609,695)
|
Comprehensive loss |
$ (2,811,783)
|
$ (3,019,896)
|
$ (14,021,710)
|
$ (10,608,522)
|
Net loss per share - basic |
$ (1.30)
|
$ (1.46)
|
$ (6.62)
|
$ (8.11)
|
Net loss per share - diluted |
$ (1.30)
|
$ (1.46)
|
$ (6.62)
|
$ (8.11)
|
Weighted average shares outstanding, basic |
2,164,656
|
1,787,235
|
2,117,153
|
1,232,936
|
Weighted average shares outstanding, diluted |
2,164,656
|
1,787,235
|
2,117,153
|
1,232,936
|
X |
- DefinitionAmount after tax of increase (decrease) in equity from transactions and other events and circumstances from net income and other comprehensive income, attributable to parent entity. Excludes changes in equity resulting from investments by owners and distributions to owners.
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v3.23.3
Condensed Consolidated Statements of Changes in Mezzanine Equity and Shareholders' Equity (Unaudited) - USD ($)
|
Series C Redeemable Preferred Stock [Member] |
Redeemable Noncontrolling Interest [Member] |
Mezzanine Equity [Member] |
Common Stock [Member] |
Additional Paid-in Capital [Member] |
Retained Earnings [Member] |
AOCI Attributable to Parent [Member] |
Total |
Balance at Dec. 31, 2021 |
|
|
|
$ 6,519
|
$ 83,066,656
|
$ (60,736,453)
|
$ (30,802)
|
$ 22,305,920
|
Mezzanine equity beginning balance, shares at Dec. 31, 2021 |
|
|
|
|
|
|
|
|
Beginning balance, shares at Dec. 31, 2021 |
|
|
|
651,921
|
|
|
|
|
Stock-based compensation |
|
|
|
|
768,619
|
|
|
768,619
|
Foreign exchange translation loss |
|
|
|
|
|
|
88,709
|
88,709
|
Net loss |
|
|
|
|
|
(4,524,014)
|
|
(4,524,014)
|
February 2022 registered direct offering |
|
|
|
$ 4,000
|
5,798,464
|
|
|
5,802,464
|
February 2022 registered direct offering, shares |
|
|
|
400,000
|
|
|
|
|
Conversion of RSUs into common shares |
|
|
|
$ 9
|
(9)
|
|
|
|
Conversion of RSUs into common shares, shares |
|
|
|
899
|
|
|
|
|
Balance at Mar. 31, 2022 |
|
|
|
$ 10,528
|
89,633,730
|
(65,260,467)
|
57,907
|
24,441,698
|
Mezzanine equity ending balance, shares at Mar. 31, 2022 |
|
|
|
|
|
|
|
|
Ending balance, shares at Mar. 31, 2022 |
|
|
|
1,052,820
|
|
|
|
|
Balance at Dec. 31, 2021 |
|
|
|
$ 6,519
|
83,066,656
|
(60,736,453)
|
(30,802)
|
22,305,920
|
Mezzanine equity beginning balance, shares at Dec. 31, 2021 |
|
|
|
|
|
|
|
|
Beginning balance, shares at Dec. 31, 2021 |
|
|
|
651,921
|
|
|
|
|
Preferred dividends attributable to redeemable non-controlling interest |
|
|
|
|
|
|
|
(20,411)
|
Accretion of embedded derivatives to redemption value |
|
|
|
|
|
|
|
(184,985)
|
Foreign exchange translation loss |
|
|
|
|
|
|
|
(609,695)
|
Net loss |
|
|
|
|
|
|
|
(9,793,431)
|
Issuance of common shares in exchange for RSU conversions, shares |
|
|
|
2,122
|
|
|
|
|
Balance at Sep. 30, 2022 |
|
$ 761,434
|
761,434
|
$ 20,782
|
93,989,885
|
(70,529,884)
|
(640,497)
|
22,840,286
|
Mezzanine equity ending balance, shares at Sep. 30, 2022 |
|
1,000
|
|
|
|
|
|
|
Ending balance, shares at Sep. 30, 2022 |
|
|
|
2,078,271
|
|
|
|
|
Balance at Mar. 31, 2022 |
|
|
|
$ 10,528
|
89,633,730
|
(65,260,467)
|
57,907
|
24,441,698
|
Mezzanine equity beginning balance, shares at Mar. 31, 2022 |
|
|
|
|
|
|
|
|
Beginning balance, shares at Mar. 31, 2022 |
|
|
|
1,052,820
|
|
|
|
|
Stock-based compensation |
|
|
|
|
677,543
|
|
|
677,543
|
Preferred dividends attributable to redeemable non-controlling interest |
|
7,808
|
7,808
|
|
(7,808)
|
|
|
(7,808)
|
Accretion of embedded derivatives to redemption value |
|
73,994
|
73,994
|
|
(73,994)
|
|
|
(73,994)
|
Foreign exchange translation loss |
|
|
|
|
|
|
(281,014)
|
(281,014)
|
Net loss |
|
|
|
|
|
(2,790,505)
|
|
(2,790,505)
|
Redeemable non-controlling interest, net of $402,000 embedded derivative and net of issuance costs of $41,962 |
|
$ 556,038
|
556,038
|
|
|
|
|
|
Redeemable non-controlling interest, shares |
|
1,000
|
|
|
|
|
|
|
Issuance of redeemable non-controlling Series C preferred stock |
$ 527
|
|
527
|
|
(527)
|
|
|
(527)
|
Issuance of redeemable non-controlling Series C preferred stock, shares |
52,685
|
|
|
|
|
|
|
|
Conversion of RSAs into common shares |
|
|
|
$ 12
|
(12)
|
|
|
|
Conversion of RSAs into common shares, shares |
|
|
|
1,223
|
|
|
|
|
Balance at Jun. 30, 2022 |
$ 527
|
$ 637,840
|
638,367
|
$ 10,540
|
90,228,932
|
(68,050,972)
|
(223,107)
|
21,965,393
|
Mezzanine equity ending balance, shares at Jun. 30, 2022 |
52,685
|
1,000
|
|
|
|
|
|
|
Ending balance, shares at Jun. 30, 2022 |
|
|
|
1,054,043
|
|
|
|
|
Stock-based compensation |
|
|
|
|
645,137
|
|
|
645,137
|
Preferred dividends attributable to redeemable non-controlling interest |
|
12,603
|
12,603
|
|
(12,603)
|
|
|
(12,603)
|
Accretion of embedded derivatives to redemption value |
|
110,991
|
110,991
|
|
(110,991)
|
|
|
(110,991)
|
Foreign exchange translation loss |
|
|
|
|
|
|
(417,390)
|
(417,390)
|
Net loss |
|
|
|
|
|
(2,478,912)
|
|
(2,478,912)
|
Redemption of Series C preferred stock |
(527)
|
|
(527)
|
|
527
|
|
|
527
|
Redemption of Series C preferred stock, shares |
|
(52,685)
|
|
|
|
|
|
|
July 2022 registered direct offering, PIPE offering, modification of warrants and exercise of pre-funded warrants, net of offering costs |
|
|
|
$ 10,000
|
3,239,125
|
|
|
3,249,125
|
July 2022 registered direct offering, PIPE offering, modification of warrants and exercise of pre-funded warrants, net of offering costs, shares |
|
|
|
1,000,000
|
|
|
|
|
Issuance of rounded shares as a result of the reverse stock split |
|
|
|
$ 242
|
(242)
|
|
|
|
Issuance of rounded shares as a result of the reverse stock split, shares |
|
|
|
24,228
|
|
|
|
|
Balance at Sep. 30, 2022 |
|
$ 761,434
|
761,434
|
$ 20,782
|
93,989,885
|
(70,529,884)
|
(640,497)
|
22,840,286
|
Mezzanine equity ending balance, shares at Sep. 30, 2022 |
|
1,000
|
|
|
|
|
|
|
Ending balance, shares at Sep. 30, 2022 |
|
|
|
2,078,271
|
|
|
|
|
Balance at Dec. 31, 2022 |
|
$ 885,028
|
885,028
|
$ 20,782
|
94,395,662
|
(79,207,786)
|
(536,734)
|
14,671,924
|
Mezzanine equity beginning balance, shares at Dec. 31, 2022 |
|
1,000
|
|
|
|
|
|
|
Beginning balance, shares at Dec. 31, 2022 |
|
|
|
2,078,271
|
|
|
|
|
Stock-based compensation |
|
|
|
|
532,835
|
|
|
532,835
|
Preferred dividends attributable to redeemable non-controlling interest |
|
12,329
|
12,329
|
|
(12,329)
|
|
|
(12,329)
|
Accretion of embedded derivatives to redemption value |
|
110,991
|
110,991
|
|
(110,991)
|
|
|
(110,991)
|
Foreign exchange translation loss |
|
|
|
|
|
|
1,968
|
1,968
|
Net loss |
|
|
|
|
|
(4,677,527)
|
|
(4,677,527)
|
Balance at Mar. 31, 2023 |
|
$ 1,008,348
|
1,008,348
|
$ 20,782
|
94,805,177
|
(83,885,313)
|
(534,766)
|
10,405,880
|
Mezzanine equity ending balance, shares at Mar. 31, 2023 |
|
1,000
|
|
|
|
|
|
|
Ending balance, shares at Mar. 31, 2023 |
|
|
|
2,078,271
|
|
|
|
|
Balance at Dec. 31, 2022 |
|
$ 885,028
|
885,028
|
$ 20,782
|
94,395,662
|
(79,207,786)
|
(536,734)
|
14,671,924
|
Mezzanine equity beginning balance, shares at Dec. 31, 2022 |
|
1,000
|
|
|
|
|
|
|
Beginning balance, shares at Dec. 31, 2022 |
|
|
|
2,078,271
|
|
|
|
|
Preferred dividends attributable to redeemable non-controlling interest |
|
|
|
|
|
|
|
(19,041)
|
Accretion of embedded derivatives to redemption value |
|
|
|
|
|
|
|
(147,988)
|
Foreign exchange translation loss |
|
|
|
|
|
|
|
1,115
|
Net loss |
|
|
|
|
|
|
|
(13,855,796)
|
Issuance of common shares in exchange for RSU conversions, shares |
|
|
|
103,641
|
|
|
|
|
Balance at Sep. 30, 2023 |
|
|
|
$ 21,818
|
96,013,029
|
(93,063,582)
|
(535,619)
|
2,435,646
|
Mezzanine equity ending balance, shares at Sep. 30, 2023 |
|
|
|
|
|
|
|
|
Ending balance, shares at Sep. 30, 2023 |
|
|
|
2,181,912
|
|
|
|
|
Balance at Mar. 31, 2023 |
|
$ 1,008,348
|
1,008,348
|
$ 20,782
|
94,805,177
|
(83,885,313)
|
(534,766)
|
10,405,880
|
Mezzanine equity beginning balance, shares at Mar. 31, 2023 |
|
1,000
|
|
|
|
|
|
|
Beginning balance, shares at Mar. 31, 2023 |
|
|
|
2,078,271
|
|
|
|
|
Stock-based compensation |
|
|
|
|
879,738
|
|
|
879,738
|
Preferred dividends attributable to redeemable non-controlling interest |
|
6,712
|
6,712
|
|
(6,712)
|
|
|
(6,712)
|
Accretion of embedded derivatives to redemption value |
|
36,997
|
36,997
|
|
(36,997)
|
|
|
(36,997)
|
Foreign exchange translation loss |
|
|
|
|
|
|
(11,286)
|
(11,286)
|
Net loss |
|
|
|
|
|
(6,356,053)
|
|
(6,356,053)
|
Redemption of Series C preferred stock |
|
$ (1,052,057)
|
(1,052,057)
|
|
|
|
|
|
Redemption of Series C preferred stock, shares |
|
(1,000)
|
|
|
|
|
|
|
Issuance of common shares in exchange for RSU conversions |
|
|
|
$ 635
|
(635)
|
|
|
|
Issuance of common shares in exchange for RSU conversions, shares |
|
|
|
63,511
|
|
|
|
|
Balance at Jun. 30, 2023 |
|
|
|
$ 21,417
|
95,640,571
|
(90,241,366)
|
(546,052)
|
4,874,570
|
Mezzanine equity ending balance, shares at Jun. 30, 2023 |
|
|
|
|
|
|
|
|
Ending balance, shares at Jun. 30, 2023 |
|
|
|
2,141,782
|
|
|
|
|
Stock-based compensation |
|
|
|
|
372,859
|
|
|
372,859
|
Foreign exchange translation loss |
|
|
|
|
|
|
10,433
|
10,433
|
Net loss |
|
|
|
|
|
(2,822,216)
|
|
(2,822,216)
|
Issuance of common shares in exchange for RSU conversions |
|
|
|
$ 401
|
(401)
|
|
|
|
Issuance of common shares in exchange for RSU conversions, shares |
|
|
|
40,130
|
|
|
|
|
Balance at Sep. 30, 2023 |
|
|
|
$ 21,818
|
$ 96,013,029
|
$ (93,063,582)
|
$ (535,619)
|
$ 2,435,646
|
Mezzanine equity ending balance, shares at Sep. 30, 2023 |
|
|
|
|
|
|
|
|
Ending balance, shares at Sep. 30, 2023 |
|
|
|
2,181,912
|
|
|
|
|
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Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($)
|
3 Months Ended |
9 Months Ended |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Cash Flows From Operating Activities: |
|
|
|
Net loss |
$ (2,478,912)
|
$ (13,855,796)
|
$ (9,793,431)
|
Adjustments to reconcile net loss to cash used in operating activities |
|
|
|
Change in fair value of warrant liability |
(1,599,623)
|
115,342
|
(3,845,514)
|
Change in fair value of investment option liability |
(1,809,622)
|
399,921
|
(1,809,622)
|
Change in fair value of derivative liability |
231,000
|
(727,000)
|
284,000
|
Stock-based compensation |
|
1,785,432
|
2,091,299
|
Amortization of right-of-use asset |
|
64,246
|
103,365
|
Amortization of intangible assets |
42,191
|
126,566
|
126,563
|
Depreciation expense |
44,458
|
132,734
|
114,850
|
Gain on disposal of property and equipment |
|
(4,219)
|
|
Change in operating assets and liabilities: |
|
|
|
Prepaid expenses and other current assets |
|
(746,033)
|
(758,419)
|
Accounts payable and accrued liabilities |
|
429,688
|
(106,675)
|
Right-of-use operating lease liability |
|
(64,244)
|
(91,022)
|
Net cash used in operating activities |
|
(12,343,363)
|
(13,684,606)
|
Cash Flows From Investing Activities: |
|
|
|
Purchases of property and equipment |
|
(5,195)
|
(577,972)
|
Proceeds from disposal of property and equipment |
|
16,900
|
|
Net cash provided by (used in) investing activities |
|
11,705
|
(577,972)
|
Cash Flows From Financing Activities: |
|
|
|
Payment for the deferred offering costs from the equity distribution agreement |
|
(105,000)
|
|
Proceeds from sale of common stock, warrants, and investment options, net of offering costs |
|
|
17,222,100
|
Redemption of Series A Preferred Stock (see Note 8) |
|
(1,052,057)
|
|
Proceeds from the sale of redeemable non-controlling interest, net of offering |
|
|
958,038
|
Net cash (used in) provided by financing activities |
|
(1,157,057)
|
18,180,138
|
Effect of foreign exchange rate on cash |
|
31,399
|
(72,554)
|
Net (decrease) increase in cash |
|
(13,457,316)
|
3,845,006
|
Cash at beginning of period |
|
17,723,884
|
17,355,999
|
Cash at end of period |
21,201,005
|
4,266,568
|
21,201,005
|
Supplemental disclosure of cash and non-cash transactions: |
|
|
|
Cash paid for interest |
|
|
5,114
|
Income taxes paid |
|
6,595
|
|
Warrants issued in conjunction with common stock issuance |
|
|
3,595,420
|
Issuance of embedded derivative |
|
|
402,000
|
Issuance of redeemable non-controlling Series C preferred stock |
|
|
|
Offering costs accrued not paid |
|
20,800
|
|
Preferred dividends attributable to redeemable non-controlling interest |
12,603
|
19,041
|
20,411
|
Accretion of embedded derivative to redemption value |
$ 110,991
|
147,988
|
184,985
|
Investment options issued in conjunction with common stock issuance |
|
|
4,323,734
|
Modification of warrants as part of share capital raise |
|
|
$ 251,357
|
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v3.23.3
BUSINESS AND LIQUIDITY AND OTHER UNCERTAINTIES
|
9 Months Ended |
Sep. 30, 2023 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
BUSINESS AND LIQUIDITY AND OTHER UNCERTAINTIES |
NOTE
1. BUSINESS AND LIQUIDITY AND OTHER UNCERTAINTIES
Nature
of Operations
Enveric
Biosciences, Inc. (“Enveric” or the “Company”) is a biotechnology company developing novel neuroplastogenic small-molecule
therapeutics for the treatment of depression, anxiety, and addiction disorders. The head office of the Company is located in Naples,
Florida. The Company has the following wholly-owned subsidiaries: Jay Pharma Inc. (“Jay Pharma”), 1306432 B.C. Ltd. (“HoldCo”),
MagicMed Industries, Inc. (“MagicMed”), Enveric Canada Inc., and Enveric Therapeutics, Pty. Ltd. (“Enveric Therapeutics”).
Leveraging
its unique discovery and development platform, The Psybrary™, Enveric has created a robust Intellectual Property portfolio of New
Chemical Entities for specific mental health indications. Enveric’s lead program, the EVM201 Series, comprises next generation
synthetic prodrugs of the active metabolite, psilocin. Enveric is developing the first product from the EVM201 Series – EB-373
– for the treatment of psychiatric disorders. Enveric is also advancing its second program, the EVM301 Series, expected to offer
a first-in-class, new approach to the treatment of difficult-to-address mental health disorders, mediated by the promotion of neuroplasticity
without also inducing hallucinations in the patient.
Following
the Company’s amalgamation with MagicMed completed in September 2021 (the “Amalgamation”), the Company has continued
to pursue the development of MagicMed’s proprietary Psychedelic Derivatives library, the Psybrary™ which the Company believes
will help to identify and develop the right drug candidates needed to address mental health challenges, including cancer-related distress.
The Company synthesizes novel versions of classic psychedelics, such as psilocybin, DMT, mescaline and MDMA, using a mixture of chemistry
and synthetic biology, resulting in the expansion of the Psybrary™, which includes 15 patent families with over a million potential
variations and hundreds of synthesized molecules. Within the Psybrary™ the Company has three different types of molecules, Generation
1 (classic psychedelics), Generation 2 (pro-drugs), and Generation 3 (new chemical entities). The Company is working to add novel psychedelic
molecular compounds and derivatives (“Psychedelic Derivatives”) on a regular basis through its work at the Company’s
labs in Calgary, Alberta, Canada, where the Company has a team of PhD scientists with expertise in synthetic biology and chemistry. To
date the Company has created over 500 molecules that are housed in the Psybrary™.
The
Company screens newly synthesized molecules in the Psybrary™ through PsyAI™, a proprietary artificial intelligence (“AI”)
tool. Leveraging AI systems is expected to reduce the time and cost of pre-clinical, clinical, and commercial development. The Company
believes it streamlines pharmaceutical design by predicting ideal binding structures of molecules, manufacturing capabilities, and pharmacological
effects to help determine ideal drug candidates, tailored to each indication. Each of these molecules that the Company believes are patentable
can then be further screened to see how changes to its makeup alter its effects in order to synthesize additional new molecules. New
compounds of sufficient purity are undergoing pharmacological screening, including non-clinical (receptors/cell lines), preclinical (animal),
and ultimately clinical (human) evaluations. The Company intends to utilize the Psybrary™ and the AI tool to categorize and characterize
the Psybrary™ substituents to focus on bringing more psychedelics-inspired molecules from discovery to the clinical phase.
Akos
Spin-Off
On
May 11, 2022, the Company announced plans to transfer and spin-off its cannabinoid clinical development pipeline assets to Akos Biosciences,
Inc. (formerly known as Acanna Therapeutics, Inc.), a majority-owned subsidiary of the Company (hereafter referred to as “Akos”),
which was incorporated on April 13, 2022, by way of dividend to Enveric shareholders (the “Spin-Off”). As of May 12, 2023,
the holders of the Company’s Akos Series A Preferred Stock, par value $0.01 per share (“Akos Series A Preferred Stock”)
have exercised this right to force redemption of all of the Akos Series A Preferred Stock for $1,000 per share, plus accrued but unpaid
dividends of $52,057 for a total of $1,052,057. The Company made full payment on May 19, 2023. See Note 8.
Australian
Subsidiary
On
March 21, 2023, the Company established Enveric Therapeutics, an Australia-based subsidiary, to support the Company’s plans to
advance its lead program, the EVM201 Series, comprised of the next generation synthetic prodrugs of the active metabolite, psilocin (“EVM201
Series”), towards the clinic. Enveric Therapeutics will oversee the Company’s preclinical, clinical, and regulatory activities
in Australia, including ongoing interactions with the local Human Research Ethics Committees (HREC) and the Therapeutic Goods Administration
(TGA), Australia’s regulatory authority.
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Going
Concern, Liquidity and Other Uncertainties
The
Company has incurred a loss since inception resulting in an accumulated deficit of $93,063,582 as of September 30, 2023, and further
losses are anticipated in the development of its business. Further, the Company had operating cash outflows of $12,343,363 for the nine
months ended September 30, 2023. For the nine months ended September 30, 2023, the Company had a loss from operations of $14,064,080.
Since its inception, being a research and development company, the Company has not yet generated revenue and the Company has incurred
continuing losses from its operations. The Company’s operations have been funded principally through the issuance of debt and equity.
These factors raise substantial doubt about the Company’s ability to continue as a going concern for a period of one year from
the issuance of these financial statements.
In
assessing the Company’s ability to continue as a going concern, the Company monitors and analyzes its cash and its ability to generate
sufficient cash flow in the future to support its operating and capital expenditure commitments. At September 30, 2023, the Company had
cash of $4,266,568 and working capital of $1,643,374. The Company’s current cash on hand is insufficient to satisfy its operating
cash needs for the 12 months following the filing of this Quarterly Report on Form 10-Q. These conditions raise substantial doubt regarding
the Company’s ability to continue as a going concern for a period of one year after the date the financial statements are issued.
Management’s plan to alleviate the conditions that raise substantial doubt include reducing the Company’s rate of spend,
managing its cash flow, advancing its programs, and raising additional working capital through public or private equity or debt financings
or other sources, which has included the Equity Distribution Agreement with Canaccord for proceeds of up to $2.4 million (see Note 7) and the Purchase Agreement with Lincoln Park (see Note 10), subject to registration, and may include collaborations
with additional third parties, as well as disciplined cash spending, to increase the Company’s cash runway. Adequate additional
financing may not be available to the Company on acceptable terms, or at all. Should the Company be unable to raise sufficient additional
capital, the Company may be required to undertake cost-cutting measures including delaying or discontinuing certain operating activities.
The
Company’s material cash requirements consist of working capital to fund capital expenditures incurred at their research facility
in Calgary and their operations, which consist primarily of, without limitation, employee related expenses, product development activities
conducted by third parties, research materials and lab supplies, facility related expenses including rent and maintenance, costs associated
with preclinical studies, patent related costs, costs of regulatory and public company compliance, insurance costs, audit costs, consultants
and legal fees. Additionally, the Company currently utilizes third-party contract research organizations (“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 manufacturing organizations (“CMOs”) to carry out their clinical
manufacturing activities as it does not yet have a commercialization infrastructure, and incur significant expenses related to developing
its internal commercialization capability to support product sales, marketing and distribution. The Company’s current working capital
resources are insufficient to fund these material cash requirements for the next twelve months.
As
a result of these factors, management has concluded that there is substantial doubt about the Company’s ability to continue as
a going concern for a period of one year after the date of the financial statements are issued. The Company’s unaudited condensed
consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Reduction
in Force/Restructuring
In
May 2023, the Company entered into a cost reduction plan, including a reduction in force of approximately 35% of its full-time employees
to streamline its operations and conserve cash resources. Additionally, contracts with seven consultants that were focused on the Akos
cannabinoid spin-out were terminated. The Company recognized severance charges of approximately $453,059 through September 30, 2023.
The plan included a focus on progressing the Company’s existing non-cannabinoid pipeline while reducing the rate of spend and managing
cash flow. In June 2023, the Company completed the reduction in force, with such severance expenses recorded in general and administrative
accounts.
On
June 16, 2023, the Company entered into a separation agreement with Avani Kanubaddi, the Company’s President and Chief Operating
Officer (the “Kanubaddi Separation Agreement”). In accordance with the Kanubaddi Separation Agreement, Mr. Kanubaddi’s
outstanding restricted stock units (“RSUs”) will retain their vesting conditions. Mr. Kanubaddi’s 2023 salary and benefits
of $550,974 were accrued and will be paid out in twelve equal monthly installments beginning in July 2023. Upon termination, any unvested
time-based RSUs became fully vested. The Company accelerated expense recognized related to these shares that vested was $231,273. Of
the 11,278 market performance-based RSUs previously granted, 3,759 will continue to be subject to the original terms and conditions of
Mr. Kanubaddi’s employment agreement and the remainder were forfeited.
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
SCHEDULE
OF RESTRUCTURING COSTS PAYABLE
| |
Accrued Restructuring Costs | |
January 1, 2023 Beginning balance | |
$ | — | |
Restructuring costs incurred | |
| 1,004,033 | |
Restructuring costs paid | |
| (396,431 | ) |
September 30, 2023 ending balance | |
$ | 607,602 | |
Inflation
Risks
The
Company considers the current inflationary trend existing in the North American economic environment reasonably likely to have a material
unfavorable impact on results of continuing operations. Higher rates of price inflation, as compared to recent prior levels of price
inflation, have caused a general increase in the cost of labor and materials. In addition, there is an increased risk of the Company
experiencing labor shortages due to a potential inability to attract and retain human resources due to increased labor costs resulting
from the current inflationary environment.
|
X |
- DefinitionThe entire disclosure for the nature of an entity's business, major products or services, principal markets including location, and the relative importance of its operations in each business and the basis for the determination, including but not limited to, assets, revenues, or earnings. For an entity that has not commenced principal operations, disclosures about the risks and uncertainties related to the activities in which the entity is currently engaged and an understanding of what those activities are being directed toward.
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v3.23.3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
|
9 Months Ended |
Sep. 30, 2023 |
Accounting Policies [Abstract] |
|
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES |
NOTE
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis
of Presentation and Principal of Consolidation
The
accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally
accepted in the United States (“U.S. GAAP”) for interim financial information and Article 8 of Regulation S-X. Accordingly,
they do not include all the information and footnotes required by U.S. GAAP for complete financial statements. Management’s opinion
is that all adjustments (consisting of normal accruals) considered necessary for a fair presentation have been included. Operating results
for the three and nine months ended September 30, 2023 are not necessarily indicative of the results that may be expected for the year
ending December 31, 2023. These unaudited condensed consolidated financial statements should be read in conjunction with the consolidated
financial statements for the year ended December 31, 2022, and related notes thereto included in the Company’s Annual Report on
Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on March 31, 2023 and subsequently amended on Form
10-K/A Amendment No. 1 filed with the SEC on June 9, 2023 (as amended, the “Annual Report”).
The
Company’s significant accounting policies and recent accounting standards are summarized in Note 2 of the Company’s consolidated
financial statements for the year ended December 31, 2022. There were no significant changes to these accounting policies during the
three and nine months ended September 30, 2023.
Use
of Estimates
The
preparation of the unaudited condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates
and assumptions that affect the reported amount of assets and liabilities at the date of the financial statements and expenses during
the periods reported. By their nature, these estimates are subject to measurement uncertainty and the effects on the financial statements
of changes in such estimates in future periods could be significant. Significant areas requiring management’s estimates and assumptions
include determining the fair value of transactions involving common stock and the valuation of stock-based compensation, accruals associated
with third party providers supporting research and development efforts, and estimated fair values of long lived assets used to record
impairment charges related to intangible assets. Actual results could differ from those estimates.
Foreign
Currency Translation
From
inception through September 30, 2023, the reporting currency of the Company was the United States dollar while the functional currency
of certain of the Company’s subsidiaries was the Canadian dollar and Australian dollar. For the reporting periods ended September
30, 2023 and 2022, the Company engaged in a number of transactions denominated in Canadian dollars and Australian dollars. As a result,
the Company is subject to exposure from changes in the exchange rates of the Canadian dollar and Australian dollar against the United
States dollar.
The
Company translates the assets and liabilities of its Canadian subsidiaries and Australian subsidiary into the United States dollar at
the exchange rate in effect on the balance sheet date. Revenues and expenses are translated at the average exchange rate in effect during
each monthly period. Unrealized translation gains and losses are recorded as foreign currency translation gain (loss), which is included
in the condensed consolidated statements of shareholders’ equity as a component of accumulated other comprehensive loss.
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
The
Company has not entered into any financial derivative instruments that expose it to material market risk, including any instruments designed
to hedge the impact of foreign currency exposures. The Company may, however, hedge such exposure to foreign currency exchange fluctuations
in the future.
Adjustments
that arise from exchange rate changes on transactions denominated in a currency other than the local currency are included in other comprehensive
loss in the condensed consolidated statements of operations and comprehensive loss as incurred.
Concentration
of Credit Risk
Financial
instruments that potentially subject the Company to concentrations of credit risk consist of cash accounts in a financial institution,
which at times, may exceed the federal depository insurance coverage of $250,000 in the United States and Australia and $100,000 in Canada.
The Company has not experienced losses on these accounts, and management believes the Company is not exposed to significant risks on
such accounts. As of September 30, 2023, the Company had greater than $250,000 at United States financial institutions, less than $250,000
at Australian financial institutions, and greater than $100,000 at Canadian financial institutions.
Deferred
Offering Costs
The
Company complies with the requirements of ASC Topic 340, Other Assets and Deferred Costs (“ASC 340”) and SAB 5A -
Expenses of Offering. Offering costs, which consist mainly of legal, accounting and consulting fees directly attributable to the
issuance of an equity contract to be classified in equity are recorded as a reduction in equity. During September 2023, the Company incurred
$125,800 in deferred offering costs in connection with the Equity Distribution Agreement (the “Distribution Agreement”),
with Canaccord Genuity LLC (“Canaccord”) and the Purchase Agreement (the “Purchase Agreement”) with Lincoln Park
Capital Fund, LLC (“Lincoln Park”). These deferred offering costs will be proportionately offset against the total proceeds
from the issuance of common stock available under the agreements and the Company will expense any remaining balance of deferred offering
costs if the agreements are terminated. For the three and nine months ended September 30, 2023, there were no issuances of common stock
under the agreements resulting in the deferral of offering costs.
Warrant
Liability and Investment Options
The
Company evaluates all of its financial instruments, including issued stock purchase warrants and investment options, to determine if
such instruments are derivatives or contain features that qualify as embedded derivatives, pursuant to ASC 480 “Distinguishing
Liabilities from Equity” (“ASC 480”) and FASB ASC Topic 815, “Derivatives and Hedging” (“ASC 815”).
The Company accounts for warrants and investment options for shares of the Company’s common stock that are not indexed to its own
stock as derivative liabilities at fair value on the unaudited condensed consolidated balance sheets. The Company accounts for common
stock warrants and investment options with put options as liabilities under ASC 480. Such warrants and investment options are subject
to remeasurement at each unaudited condensed consolidated balance sheet date and any change in fair value is recognized as a component
of other expense on the unaudited condensed consolidated statements of operations. The Company will continue to adjust the liability
for changes in fair value until the earlier of the exercise or expiration of such common stock warrants and investment options. At that
time, the portion of the warrant liability and investment options related to such common stock warrants will be reclassified to additional
paid-in capital.
Derivative
Liability
The
Company evaluates its financial instruments to determine if such instruments are derivatives or contain features that qualify as embedded
derivatives in accordance with ASC 815. For derivative financial instruments that are accounted for as assets or liabilities, the derivative
instrument is initially recorded at its fair value on the grant date and is then re-valued at each reporting date, with changes in the
fair value reported in the unaudited condensed consolidated statements of operations. The classification of derivative instruments, including
whether such instruments should be recorded as assets or liabilities or as equity, is evaluated at the end of each reporting period.
Derivative liabilities are classified in the unaudited condensed consolidated balance sheets as current or non-current based on whether
or not net-cash settlement or conversion of the instrument could be required within 12 months of the balance sheet date.
Income
Taxes
The
Company files U.S. federal and state returns. The Company’s foreign subsidiary also files a local tax return in their local jurisdiction.
From a U.S. federal, state, and Canadian perspective, the years that remain open to examination are consistent with each jurisdiction’s
statute of limitations.
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Net
Loss per Share
Basic
net loss per share is computed by dividing net loss by the weighted average number of shares of common stock outstanding during the period.
Diluted earnings per share is computed using the weighted average number of common shares and, if dilutive, potential common shares outstanding
during the period. Potential common shares consist of the incremental common shares issuable upon the exercise of stock options and warrants
(using the treasury stock method). The computation of basic net loss per share for the three and nine months ended September 30, 2023
and 2022 excludes potentially dilutive securities. The computations of net loss per share for each period presented is the same for both
basic and fully diluted. In accordance with ASC 260 “Earnings per Share” (“ASC 260”), penny warrants were included
in the calculation of weighted average shares outstanding for the purposes of calculating basic and diluted earnings per share.
Potentially
dilutive securities outlined in the table below have been excluded from the computation of diluted net loss per share the three and nine
months ended September 30, 2023 and 2022 because the effect of their inclusion would have been anti-dilutive.
SCHEDULE
OF POTENTIALLY DILUTIVE SECURITIES
| |
For the three and nine months ended September 30, 2023 | | |
For the three and nine months ended September 30, 2022 | |
Warrants to purchase shares of common stock | |
| 609,893 | | |
| 655,463 | |
Restricted stock units - vested and unissued | |
| 20,847 | | |
| 61,428 | |
Restricted stock units - unvested | |
| 148,251 | | |
| 65,117 | |
Restricted stock awards - vested and unissued | |
| — | | |
| 974 | |
Investment options to purchase shares of common stock | |
| 1,070,000 | | |
| 1,070,000 | |
Options to purchase shares of common stock | |
| 31,852 | | |
| 22,829 | |
Total potentially dilutive securities | |
| 1,880,843 | | |
| 1,875,811 | |
Fair
Value Measurements
Fair
value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between
market participants at the measurement date. To increase the comparability of fair value measures, the following hierarchy prioritizes
the inputs to valuation methodologies used to measure fair value:
Level
1 - Valuations based on quoted prices for identical assets and liabilities in active markets.
Level
2 - Valuations based on observable inputs other than quoted prices included in Level 1, such as quoted prices for similar assets and
liabilities in active markets, quoted prices for identical or similar assets and liabilities in markets that are not active, or other
inputs that are observable or can be corroborated by observable market data.
Level
3 - Valuations based on unobservable inputs reflecting our own assumptions, consistent with reasonably available assumptions made by
other market participants. These valuations require significant judgment.
For
certain financial instruments, including cash and accounts payable, the carrying amounts approximate their fair values as of September
30, 2023, and December 31, 2022 because of their short-term nature.
The
following table provides the financial liabilities measured on a recurring basis and reported at fair value on the balance sheet as of
September 30, 2023, and December 31, 2022, and indicates the fair value of the valuation inputs the Company utilized to determine such
fair value of warrant liabilities, derivative liability, and investment options:
SCHEDULE
OF FAIR VALUE HIERARCHY OF VALUATION INPUTS ON RECURRING BASIS
| |
Level | |
September 30, 2023 | | |
December 31, 2022 | |
Warrant liabilities - January 2021 Warrants | |
3 | |
$ | 18 | | |
$ | 81 | |
Warrant liabilities - February 2021 Warrants | |
3 | |
| 59 | | |
| 79 | |
Warrant liabilities - February 2022 Warrants | |
3 | |
| 300,480 | | |
| 185,055 | |
Fair value of warrant liability | |
| |
$ | 300,557 | | |
$ | 185,215 | |
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
| |
Level | |
September 30, 2023 | | |
December 31, 2022 | |
Derivative liability - May 2022 | |
3 | |
$ | — | | |
$ | 727,000 | |
Fair value of derivative liability | |
| |
$ | — | | |
$ | 727,000 | |
| |
Level | |
September 30, 2023 | | |
December 31, 2022 | |
H.C. Wainwright & Co., LLC investment options | |
3 | |
$ | 70,521 | | |
$ | 44,904 | |
RD investment options | |
3 | |
| 442,653 | | |
| 302,289 | |
PIPE investment options | |
3 | |
| 737,755 | | |
| 503,815 | |
Fair value of investment option liability | |
| |
$ | 1,250,929 | | |
$ | 851,008 | |
The
warrant liabilities, derivative liability, and investment options are all classified as Level 3, for which there is no current market
for these securities such as the determination of fair value requires significant judgment or estimation. Changes in fair value measurement
categorized within Level 3 of the fair value hierarchy are analyzed each period based on changes in estimates or assumptions and recorded
within other income (expense) on the condensed consolidated statements of operations and comprehensive loss.
Subsequent
measurement
The
following table presents the changes in fair value of the warrant liabilities, derivative liability, and investment options that are
classified as Level 3:
SCHEDULE
OF FAIR VALUE OF WARRANT LIABILITIES AND DERIVATIVE LIABILITY AND INVESTMENT OPTIONS
| |
Total Warrant Liabilities | |
Fair value as of December 31, 2022 | |
$ | 185,215 | |
Change in fair value | |
| 115,342 | |
Fair value as of September 30, 2023 | |
$ | 300,557 | |
| |
Total Derivative Liability | |
Fair value as of December 31, 2022 | |
$ | 727,000 | |
Change in fair value arising from redemption of Akos Series A Preferred Stock - See Note 8 | |
| (727,000 | ) |
Fair value of derivative liability as of September 30, 2023 | |
$ | — | |
| |
Total Investment Option Liability | |
Fair value as of December 31, 2022 | |
$ | 851,008 | |
Change in fair value | |
| 399,921 | |
Fair value of investment option liability as of September 30, 2023 | |
$ | 1,250,929 | |
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
The
key inputs into the Black Scholes valuation model for the Level 3 valuations of the warrant liabilities as of September 30, 2023 are
below:
SCHEDULE
OF BLACK SCHOLES VALUATION MODELS OF WARRANT LIABILITIES AND INVESTMENT OPTIONS
| |
January 2021 Warrants | | |
February 2021 Warrants | | |
February 2022 Warrants | | |
February 2022 Post-Modification Warrants | |
Term (years) | |
| 2.3 | | |
| 2.4 | | |
| 3.4 | | |
| 4.3 | |
Stock price | |
$ | 2.38 | | |
$ | 2.38 | | |
$ | 2.38 | | |
$ | 2.38 | |
Exercise price | |
$ | 247.50 | | |
$ | 245.00 | | |
$ | 27.50 | | |
$ | 7.78 | |
Dividend yield | |
| — | % | |
| — | % | |
| — | % | |
| — | % |
Expected volatility | |
| 80.0 | % | |
| 85.0 | % | |
| 96.0 | % | |
| 94.0 | % |
Risk free interest rate | |
| 5.00 | % | |
| 4.90 | % | |
| 4.80 | % | |
| 4.70 | % |
Number of warrants | |
| 36,429 | | |
| 34,281 | | |
| 338,000 | | |
| 122,000 | |
Value (per share) | |
$ | — | | |
$ | — | | |
$ | 0.46 | | |
$ | 1.18 | |
The
key inputs into the Black Scholes valuation model for the Level 3 valuations of the investment options as of September 30, 2023 are below:
| |
H.C. Wainwright & Co., LLC Options | | |
RD Offering Options | | |
PIPE Offering Options | |
Term (years) | |
| 3.8 | | |
| 4.3 | | |
| 4.3 | |
Stock price | |
$ | 2.38 | | |
$ | 2.38 | | |
$ | 2.38 | |
Exercise price | |
$ | 10.00 | | |
$ | 7.78 | | |
$ | 7.78 | |
Dividend yield | |
| — | % | |
| — | % | |
| — | % |
Expected volatility | |
| 97.0 | % | |
| 94.0 | % | |
| 94.0 | % |
Risk free interest rate | |
| 4.70 | % | |
| 4.70 | % | |
| 4.70 | % |
Number of investment options | |
| 70,000 | | |
| 375,000 | | |
| 625,000 | |
Value (per share) | |
$ | 1.01 | | |
$ | 1.18 | | |
$ | 1.18 | |
The
key inputs into the Weighted Expected Return valuation model for the Level 3 valuations of the derivative liability as of redemption,
are below:
| |
| May 2022 Derivative Liability | |
Principal | |
$ | — | |
Dividend rate | |
| — | % |
Market rate | |
| — | % |
At
the date of the redemption of the of Akos Series A Preferred Stock in May 2023, the derivative liability fair value was $0 due to the
probability of a spin-off occurring was zero. See Note 8
Redeemable
Non-controlling Interest
In
connection with the issuance of Akos Series A Preferred Stock, the Akos Purchase Agreement (as defined below in Note 8) and certificate
of designation contain a put right guaranteed by the Company as defined in Note 8. Applicable accounting guidance requires an equity
instrument that is redeemable for cash or other assets to be classified outside of permanent equity if it is redeemable (a) at a fixed
or determinable price on a fixed or determinable date, (b) at the option of the holder, or (c) upon the occurrence of an event that is
not solely within the control of the issuer. As a result of this feature, the Company recorded the non-controlling interests as redeemable
non-controlling interests and classified them in mezzanine equity within its unaudited condensed consolidated balance sheet initially
at its acquisition-date estimated redemption value or fair value. In addition, the Company has elected to recognize changes in the redemption
value immediately as they occur and adjust the carrying amount of the instrument by accreting the embedded derivative at each reporting
period over 12 months.
In
May 2023, pursuant to the Akos Series A Preferred Certificate of Designations, the holders of the Akos Series A Preferred Stock exercised
the Put Right (as defined below) requiring Akos to force redemption of all of the Akos Series A Preferred Stock. See Note 8.
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Segment
Reporting
The
Company determines its reporting units in accordance with FASB ASC 280, “Segment Reporting” (“ASC 280”). The
Company evaluates a reporting unit by first identifying its operating segments under ASC 280. The Company then evaluates each operating
segment to determine if it includes one or more components that constitute a business. If there are components within an operating segment
that meet the definition of a business, the Company evaluates those components to determine if they must be aggregated into one or more
reporting units. If applicable, when determining if it is appropriate to aggregate different operating segments, the Company determines
if the segments are economically similar and, if so, the operating segments are aggregated. The Company has multiple operations related
to psychedelics and cannabinoids. Both of these operations exist under one reporting unit: Enveric. The Company has one operating segment
and reporting unit. The Company is organized and operated as one business. Management reviews its business as a single operating segment,
using financial and other information rendered meaningful only by the fact that such information is presented and reviewed in the aggregate.
Recent
Accounting Pronouncements
In
August 2020, the FASB issued ASU 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives
and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40) (“ASU 2020-06”) to simplify certain financial
instruments. ASU 2020-06 eliminates the current models that require separation of beneficial conversion and cash conversion features
from convertible instruments and simplifies the derivative scope exception guidance pertaining to equity classification of contracts
in an entity’s own equity. The new standard also introduces additional disclosures for convertible debt and freestanding instruments
that are indexed to and settled in an entity’s own equity. ASU 2020-06 amends the diluted earnings per share guidance, including
the requirement to use the if-converted method for all convertible instruments. ASU 2020-06 is effective for fiscal years beginning after
December 15, 2023, and should be applied on a full or modified retrospective basis. Early adoption is permitted, but no earlier than
fiscal years beginning after December 15, 2020, including interim periods within those fiscal years. The Company early adopted ASU 2020-06
effective January 1, 2023, and has determined that the adoption of this guidance had no impact on its condensed consolidated financial
statements.
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v3.23.3
PREPAID EXPENSES AND OTHER CURRENT ASSETS
|
9 Months Ended |
Sep. 30, 2023 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] |
|
PREPAID EXPENSES AND OTHER CURRENT ASSETS |
NOTE
3. PREPAID EXPENSES AND OTHER CURRENT ASSETS
As
of September 30, 2023 and December 31, 2022, the prepaid expenses and other current assets of the Company consisted of the following:
SCHEDULE
OF PREPAID EXPENSES AND OTHER CURRENT ASSETS
| |
September 30, 2023 | | |
December 31, 2022 | |
Prepaid research and development | |
$ | 651,623 | | |
$ | 268,686 | |
Prepaid value-added taxes | |
| 229,909 | | |
| 159,782 | |
Prepaid professional fees | |
| 74,500 | | |
| — | |
Prepaid insurance | |
| 332,508 | | |
| 174,406 | |
Prepaid other | |
| 146,014 | | |
| 105,179 | |
Deferred offering costs | |
| 125,800 | | |
| — | |
Total prepaid expenses and other current assets | |
$ | 1,560,354 | | |
$ | 708,053 | |
|
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v3.23.3
INTANGIBLE ASSETS
|
9 Months Ended |
Sep. 30, 2023 |
Goodwill and Intangible Assets Disclosure [Abstract] |
|
INTANGIBLE ASSETS |
NOTE
4. INTANGIBLE ASSETS
As
of September 30, 2023, the Company’s intangible assets consisted of:
SCHEDULE
OF FINITE LIVED INTANGIBLE ASSETS
Definite lived intangible assets | |
| | |
Balance at December 31, 2022 | |
$ | 379,686 | |
Amortization | |
| (126,566 | ) |
Balance at September 30, 2023 | |
$ | 253,120 | |
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
For
identified definite lived intangible assets, there was no impairment expense during the three and nine months ended September 30, 2023
and 2022. For identified definite lived intangible assets, amortization expense amounted to $42,191 during the three months ended September
30, 2023, and 2022, respectively. For identified definite lived intangible assets, amortization expense amounted to $126,566 and $126,563
during the nine months ended September 30, 2023 and 2022.
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v3.23.3
PROPERTY AND EQUIPMENT
|
9 Months Ended |
Sep. 30, 2023 |
Property, Plant and Equipment [Abstract] |
|
PROPERTY AND EQUIPMENT |
NOTE
5. PROPERTY AND EQUIPMENT
Property
and equipment consists of the following assets which are located in Calgary, Canada and placed in service by Enveric Biosciences Canada,
Inc. (“EBCI”), with all amounts translated into U.S. dollars:
SCHEDULE OF PROPERTY PLANT AND EQUIPMENT NET OF ACCUMULATED DEPRECIATION
| |
September 30, 2023 | | |
December 31, 2022 | |
Lab equipment | |
$ | 818,460 | | |
$ | 831,123 | |
Computer equipment and leasehold improvements | |
| 27,759 | | |
| 25,137 | |
Less: Accumulated depreciation | |
| (307,067 | ) | |
| (178,775 | ) |
Property and equipment, net of accumulated depreciation | |
$ | 539,152 | | |
$ | 677,485 | |
Depreciation
expense was $44,105 and $44,458 for the three months ended September 30, 2023, and 2022, respectively. Depreciation expense was $132,734
and $114,850 for the nine months ended September 30, 2023 and 2022, respectively.
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v3.23.3
ACCRUED LIABILITIES
|
9 Months Ended |
Sep. 30, 2023 |
Payables and Accruals [Abstract] |
|
ACCRUED LIABILITIES |
NOTE
6. ACCRUED LIABILITIES
As
of September 30, 2023 and December 31, 2022, the accrued liabilities of the Company consisted of the following:
SCHEDULE
OF ACCRUED LIABILITIES
| |
September 30, 2023 | | |
December 31, 2022 | |
Product development | |
$ | 94,663 | | |
$ | 195,104 | |
Accrued salaries and wages | |
| 729,616 | | |
| 1,175,963 | |
Professional fees | |
| 74,499 | | |
| 83,255 | |
Accrued restructuring costs | |
| 607,602 | | |
| — | |
Accrued franchise taxes | |
| 9,449 | | |
| — | |
Patent costs | |
| 18,000 | | |
| 251,333 | |
Total accrued expenses | |
$ | 1,533,829 | | |
$ | 1,705,655 | |
|
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v3.23.3
SHARE CAPITAL AND OTHER EQUITY INSTRUMENTS
|
9 Months Ended |
Sep. 30, 2023 |
Equity [Abstract] |
|
SHARE CAPITAL AND OTHER EQUITY INSTRUMENTS |
NOTE
7. SHARE CAPITAL AND OTHER EQUITY INSTRUMENTS
Authorized
Capital
The
holders of the Company’s common stock are entitled to one vote per share. Holders of common stock are entitled to receive ratably
such dividends, if any, as may be declared by the Board of Directors out of legally available funds. Upon the liquidation, dissolution,
or winding up of the Company, holders of common stock are entitled to share ratably in all assets of the Company that are legally available
for distribution. As of September 30, 2023, 100,000,000 shares of common stock and 20,000,000 shares of Preferred Stock were authorized
under the Company’s articles of incorporation.
Equity
Distribution Agreement
On
September 1, 2023, the Company entered into the Distribution Agreement, with Canaccord, pursuant to which the Company may offer and sell
from time to time, through Canaccord as sales agent and/or principal, shares of common stock of the Company, par value $0.01 per share
having an aggregate offering price of up to $10.0 million. Due to the offering limitations applicable to the Company and in accordance
with the terms of the Distribution Agreement, the Company may offer Common Stock having an aggregate gross sales price of up to $2,392,514
pursuant to the prospectus supplement dated September 1, 2023 (the “Prospectus Supplement”). Subject to the terms and conditions
of the Distribution Agreement, Canaccord may sell the Common Stock by any method permitted by law deemed to be an “at-the-market
offering”. The Company will pay Canaccord a commission equal to 3.0% of the gross sales price of the Common Stock sold through
Canaccord under the Distribution Agreement and has also agreed to reimburse Canaccord for certain expenses. The Company may also sell
Common Stock to Canaccord as principal for Canaccord’s own account at a price agreed upon at the time of sale. Any sale of Common
Stock to Canaccord as principal would be pursuant to the terms of a separate terms agreement between the Company and Canaccord.
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
During
the three and nine months ended September 30, 2023, the Company has issued no shares of common stock through the Distribution Agreement.
The Company had capitalized deferred offering costs of $125,800 related to establishing the Distribution Agreement with Canaccord and
the Purchase Agreement with Lincoln Park and no reductions to additional paid in capital.
Common
Stock Activity
On
February 15, 2022, the Company completed a public offering of 400,000 shares of Common Stock and warrants to purchase up to 400,000 shares
of Common Stock for gross proceeds of approximately $10.0 million, before deducting underwriting discounts and commissions and other
offering expenses. A.G.P./Alliance Global Partners acted as sole book-running manager for the offering. In addition, Enveric granted
the underwriter a 45-day option to purchase up to an additional 60,000 shares of Common Stock and/or warrants to purchase up to an additional
60,000 shares of Common Stock at the public offering price, which the underwriter has partially exercised for warrants to purchase up
to 60,000 shares of common stock. At closing, Enveric received net proceeds from the offering of approximately $9.1 million, after deducting
underwriting discounts and commissions and estimated offering expenses with $5.8 million allocated to equity, $3.6 million to warrant
liability and the remaining $0.3 million recorded as an expense.
On
July 22, 2022, the Company entered into a securities purchase agreement (the “Registered Direct Securities Purchase Agreement”)
with an institutional investor for the purchase and sale of 116,500 shares of the Company’s common stock, pre-funded warrants to
purchase up to 258,500 shares of common stock (the “RD Pre-Funded Warrants”), and unregistered preferred investment options
(the “RD Preferred Investment Options”) to purchase up to 375,000 shares of common stock (the “RD Offering”).
The gross proceeds from the RD Offering were approximately $3,000,000. Subject to certain ownership limitations, the RD Pre-Funded Warrants
became immediately exercisable at an exercise price equal to $0.0001 per share of common stock. On August 3, 2022, all of the issued
RD Pre-Funded Warrants were exercised.
Concurrently
with the RD Offering, the Company entered into a securities purchase agreement (the “PIPE Securities Purchase Agreement”)
with institutional investors for the purchase and sale of 116,000 shares of common stock, pre-funded warrants to purchase up to 509,000
shares of common stock (the “PIPE Pre-Funded Warrants”), and preferred investment options (the “PIPE Preferred Investment
Options”) to purchase up to 625,000 shares of the common stock in a private placement (the “PIPE Offering”). The gross
proceeds from the PIPE Offering were approximately $5,000,000. Subject to certain ownership limitations, the PIPE Pre-Funded Warrants
became immediately exercisable at an exercise price equal to $0.0001 per share of common stock. All of the issued PIPE Pre-Funded Warrants
were exercised on various dates prior to August 18, 2022.
The
RD Offering and PIPE Offering closed on July 26, 2022, with aggregate gross proceeds of approximately $8 million. The aggregate net proceeds
from the offerings, after deducting the placement agent fees and other estimated offering expenses, were approximately $7.1 million,
with $3.2 million allocated to equity, $4.3 million to investment option liability, and the remaining $0.4 million recorded as an expense.
During
the nine months ended September 30, 2023, a total of 103,641 shares of Common Stock were issued pursuant to the conversion of restricted
stock units. During the nine months ended September 30, 2022, a total of 2,122 shares of Common Stock were issued pursuant to the conversion
of restricted stock units.
Stock
Options
Amendment
to 2020 Long-Term Incentive Plan
On
May 3, 2022, our board of directors (“Board”) adopted the First Amendment (the “Plan Amendment”) to the Enveric
Biosciences, Inc. 2020 Long-Term Incentive Plan (the “Incentive Plan”) to (i) increase the aggregate number of shares available
for the grant of awards by 146,083 shares to a total of 200,000 shares, and (ii) add an “evergreen” provision whereby the
number of shares authorized for issuance pursuant to awards under the Incentive Plan will be automatically increased on the first trading
date immediately following the date the Company issues any share of Common Stock (defined below) to any person or entity, to the extent
necessary so that the number of shares of the Company’s Common Stock authorized for issuance under the Incentive Plan will equal
the greater of (x) 200,000 shares, and (y) 15% of the total number of shares of the Company’s Common Stock outstanding as of such
issuance date. The Plan Amendment was approved by the Company’s shareholders at a special meeting of the Company’s shareholders
held on July 14, 2022.
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
A
summary of activity under the Company’s incentive plan for the nine months ended September 30, 2023, is presented below:
SCHEDULE OF STOCK OPTION
| |
Number of Shares | | |
Weighted Average Exercise Price | | |
Weighted Average Grant Date Fair Value | | |
Weighted Average Remaining Contractual Term (years) | | |
Aggregate Intrinsic Value | |
Outstanding at December 31, 2022 | |
| 48,329 | | |
$ | 37.05 | | |
$ | 44.82 | | |
| 4.1 | | |
$ | — | |
Forfeited | |
| (16,476 | ) | |
$ | 5.79 | | |
$ | 5.80 | | |
| — | | |
$ | — | |
Outstanding at September 30, 2023 | |
| 31,852 | | |
$ | 53.18 | | |
$ | 74.04 | | |
| 3.4 | | |
$ | — | |
Exercisable at September 30, 2023 | |
| 24,626 | | |
$ | 63.72 | | |
$ | 86.52 | | |
| 3.0 | | |
$ | — | |
The
Company’s stock-based compensation expense, recorded within general and administrative expense in the condensed consolidated statement
of operations and comprehensive loss, related to stock options for the three months ended September 30, 2023, and 2022 was $44,606 and
$48,697, respectively. The Company’s stock-based compensation expense, recorded within general and administrative expense, related
to stock options for the nine months ended September 30, 2023 and 2022 was $147,067 and $134,383, respectively. As of September 30, 2023,
the Company had $93,697 in unamortized stock option expense, which will be recognized over a weighted average period of 1 year.
Restricted
Stock Awards
For
the three months ended September 30, 2023, and 2022, the Company recorded $0 and $6,250, respectively, in stock-based compensation expense
within general and administrative expense, related to restricted stock awards. For the nine months ended September 30, 2023 and 2022,
the Company recorded $0 and $24,363, respectively, in stock-based compensation expense within general and administrative expense, related
to restricted stock awards. As of September 30, 2023, there were no unamortized stock-based compensation costs related to restricted
share awards. During the three months ended September 30, 2023, the Company settled the 708 vested and unissued shares for cash of $14,250.
As of September 30, 2023, there are 0 vested and unissued shares of restricted stock awards.
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Issuance
of Restricted Stock Units
The
Company’s activity in restricted stock units was as follows for the nine months ended September 30, 2023:
SCHEDULE OF RESTRICTED STOCK UNITS AND AWARDS ACTIVITY
| |
Number of shares | | |
Weighted average
fair value | |
Non-vested at December 31, 2022 | |
| 64,053 | | |
$ | 92.57 | |
Granted | |
| 182,500 | | |
$ | 2.73 | |
Vested | |
| (62,636 | ) | |
$ | 19.80 | |
Forfeited | |
| (35,666 | ) | |
$ | 27.45 | |
Non-vested at September 30, 2023 | |
| 148,251 | | |
$ | 28.39 | |
For
the three months ended September 30, 2023, and 2022, the Company recorded $328,253 and $590,190, respectively, in stock-based compensation
expense related to restricted stock units. For the nine months ended September 30, 2023 and 2022, the Company recorded $1,638,365 and
$1,932,553 respectively, in stock-based compensation expense related to restricted stock units, which is a component of both general
and administrative and research and development expenses in the condensed consolidated statement of operations and comprehensive loss.
As of September 30, 2023, the Company had unamortized stock-based compensation costs related to restricted stock units of $2,388,221
which will be recognized over a weighted average period of 2.3 years and unamortized stock-based costs related to restricted stock units
which will be recognized upon achievement of specified milestones. As of September 30, 2023, 20,847 restricted stock units are vested
without shares of common stock being issued, with all of these shares due as of September 30, 2023.
The
following table summarizes the Company’s recognition of stock-based compensation for restricted stock units for the following periods:
SCHEDULE OF STOCK-BASED COMPENSATION FOR RESTRICTED STOCK UNITS
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three months ended
September 30, | | |
Nine months ended
September 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Stock-based compensation expense for RSUs: | |
| | | |
| | | |
| | | |
| | |
General and administrative | |
$ | 101,607 | | |
$ | 357,756 | | |
$ | 946,851 | | |
$ | 1,138,080 | |
Research and development | |
| 226,646 | | |
| 232,434 | | |
| 691,514 | | |
| 794,473 | |
Total | |
$ | 328,253 | | |
$ | 590,190 | | |
$ | 1,638,365 | | |
$ | 1,932,553 | |
Warrants
The
following table summarizes information about shares issuable under warrants outstanding on September 30, 2023:
SCHEDULE
OF WARRANTS OUTSTANDING
| |
Warrant shares outstanding | | |
Weighted average exercise price | | |
Weighted average remaining life | | |
Intrinsic value | |
Outstanding at December 31, 2022 | |
| 655,463 | | |
$ | 58.36 | | |
| 3.6 | | |
$ | 5,514 | |
Expired | |
| (45,570 | ) | |
$ | 111.50 | | |
| — | | |
$ | — | |
Outstanding at September 30, 2023 | |
| 609,893 | | |
$ | 50.46 | | |
| 2.9 | | |
$ | — | |
Exercisable at September 30, 2023 | |
| 609,893 | | |
$ | 50.46 | | |
| 2.9 | | |
$ | — | |
The
warrants assumed pursuant to the acquisition of MagicMed contain certain down round features, which were not triggered by the February
2022 public offering and July 2022 RD Offering, that would require adjustment to the exercise price upon certain events when the offering
price is less than the stated exercise price.
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Preferred
Investment Options
The
following table summarizes information about investment options outstanding on September 30, 2023:
SCHEDULE
OF WARRANTS AND INVESTMENT OPTIONS
| |
Investment options outstanding | | |
Weighted average exercise price | | |
Weighted average remaining life | | |
Intrinsic value | |
Outstanding at December 31, 2022 | |
| 1,070,000 | | |
$ | 7.93 | | |
| 5.1 | | |
$ | — | |
Outstanding at September 30, 2023 | |
| 1,070,000 | | |
$ | 7.93 | | |
| 4.3 | | |
$ | — | |
Exercisable at September 30, 2023 | |
| 1,070,000 | | |
$ | 7.93 | | |
| 4.3 | | |
$ | — | |
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v3.23.3
REDEEMABLE NON-CONTROLLING INTEREST
|
9 Months Ended |
Sep. 30, 2023 |
Redeemable Non-controlling Interest |
|
REDEEMABLE NON-CONTROLLING INTEREST |
NOTE
8. REDEEMABLE NON-CONTROLLING INTEREST
Spin-Off
and Related Private Placement
In
connection with the Spin-Off, on May 5, 2022, Akos and the Company entered into into a Securities Purchase Agreement (the “Akos
Purchase Agreement”) with an accredited investor (the “Akos Investor”), pursuant to which Akos agreed to sell up to
an aggregate of 5,000 shares of Akos Series A Preferred Stock, at price of $1,000 per share, and warrants (the “Akos Warrants”)
Akos Warrants to purchase shares of Akos’ common stock, par value $0.01 per share (the “Akos Common Stock”), for an
aggregate purchase price of up to $5,000,000 (the “Akos Private Placement”). The Akos Purchase Agreement was guaranteed by
the Company. Pursuant to the Akos Purchase Agreement, Akos issued 1,000 shares of the Akos Series A Preferred Stock to the Akos Investor
in exchange for $1,000,000 on May 5, 2022. The additional $4,000,000 was to be received on or immediately prior to the Spin-Off. The
issuance of the Akos Series A Preferred Stock results in RNCI (see Note 2). Palladium Capital Advisors, LLC (“Palladium”)
acted as placement agent for the Akos Private Placement. Pursuant to the Akos Purchase Agreement, Akos had agreed to pay Palladium a
fee equal to 9% of the aggregate gross proceeds raised from the sale of the shares of the Akos Series A Preferred Stock and a non-accountable
expense allowance of 1% of the aggregate gross proceeds raised the sale of the Akos Series A Preferred Stock in the Akos Private Placement.
The fee due in connection with the Akos Private Placement to be paid to Palladium in the form of convertible preferred stock and warrants
was on similar terms to the securities issued in the Akos Private Placement. Palladium was also entitled to warrants to purchase Akos
Common Stock in an amount up to 8% of the number of shares of Akos Common Stock underlying the shares issuable upon conversion of the
Akos Series A Preferred Stock. As of September 30, 2023, no accruals are required to be recorded for the fees or warrants since the Akos
Series A Preferred Stock has been redeemed.
Terms
of Akos Series A Preferred Stock
Under
the Certificate of the Designations, Preferences, and Rights of Series A Convertible Preferred Stock of Akos (the “Akos Series
A Preferred Certificate of Designations”), on or immediately prior to the completion of the spin-off of Akos into an independent,
separately traded public company listed on the Nasdaq Stock Market, the outstanding Akos Series A Preferred Stock automatically converted
into a number of shares of Akos Common Stock equal to 25% of the then issued and outstanding Akos Common Stock, subject to the Beneficial
Ownership Limitation (as defined in the Akos Purchase Agreement). Cumulative dividends on each share of Akos Series A Preferred Stock
accrue at the rate of 5% annually.
The
Akos Series A Preferred Certificate of Designations provided that upon the earlier of (i) the one-year anniversary of May 5, 2022, and
only in the event that the Spin-Off has not occurred; or (ii) such time that Akos and the Company have abandoned the Spin-Off or the
Company is no longer pursuing the Spin-Off in good faith, the holders of the Akos Series A Preferred Stock shall have the right (the
“Put Right”), but not the obligation, to cause Akos to purchase all or a portion of the Akos Series A Preferred Stock for
a purchase price equal to $1,000 per share, subject to certain adjustments as set forth in the Akos Series A Preferred Certificate of
Designations (the “Stated Value”), plus all the accrued but unpaid dividends per share. In addition, after the one-year anniversary
of May 5, 2022, and only in the event that the Spin-Off has not occurred and Akos is not in material default of any of the transaction
documents, Akos may, at its option, at any time and from time to time, redeem the outstanding shares of Akos Series A Preferred Stock,
in whole or in part, for a purchase price equal to the aggregate Stated Value of the shares of Akos Series A Preferred Stock being redeemed
and the accrued and unpaid dividends on such shares. Pursuant to the Akos Purchase Agreement, the Company has guaranteed the payment
of the purchase price for the shares purchased under the Put Right.
The
Akos Series A Preferred Certificate of Designations contains limitations that prevent the holder thereof from acquiring shares of Akos
Common Stock upon conversion of the Akos Series A Preferred Stock that would result in the number of shares of Akos Common Stock beneficially
owned by such holder and its affiliates exceeding 9.99% of the total number of shares of Akos Common Stock outstanding immediately after
giving effect to the conversion (the “Beneficial Ownership Limitation”), except that upon notice from the holder to Akos,
the holder may increase or decrease the limit of the amount of ownership of outstanding shares of Akos Common Stock after converting
the holder’s shares of Akos Series A Preferred Stock, provided that any change in the Beneficial Ownership Limitation shall not
be effective until 61 days following notice to Akos.
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Redemption
of Akos Series A Preferred Stock
In
May 2023, pursuant to the Akos Series A Preferred Certificate of Designations, the holders of the Akos Series A Preferred Stock exercised
the Put Right requiring Akos to force redemption of all of the Akos Series A Preferred Stock for $1,000 per share, plus accrued
but unpaid dividends of approximately $52,000 for a total of approximately $1,052,000. The Company had 20 days following the receipt
of the Put Exercise Notice to make the payment and made payment on May 19, 2023. Upon redemption in May 2023, the Company revalued the
derivative liability and the Company recognized a change in fair value of the derivative liability on the Company’s condensed consolidated
statement of operations during the second quarter of 2023 of $714,000.
The
Company, Akos, and the Akos Investor have terminated the Akos Purchase Agreement in connection with the planned Spin-Off and certain
registration rights agreement in connection with the Akos Private Placement.
Accounting
for Akos Series A Preferred Stock
Since
the shares of Akos Series A Preferred Stock were redeemable at the option of the holder and the redemption is not solely in the control
of the Company, the shares of Akos Series A Preferred Stock were accounted for as a redeemable non-controlling interest and classified
within mezzanine equity in the Company’s condensed consolidated balance sheets. The redeemable non-controlling interest was initially
measured at fair value. Dividends on the shares of Akos Series A Preferred Stock were recognized as preferred dividends attributable
to redeemable non-controlling interest in the Company’s condensed consolidated statement of operations and comprehensive loss.
The
table below presents the reconciliation of changes in redeemable non-controlling interest:
SCHEDULE OF RECONCILIATION CHANGE IN REDEEMABLE NONCONTROLLING INTEREST
Balance at December 31, 2022 | |
$ | 885,028 | |
Preferred dividends attributable to redeemable non-controlling interest | |
| 19,041 | |
Accretion of embedded derivative and transaction costs associated with Akos Series A Preferred | |
| 147,988 | |
Redemption of Akos Series A Preferred Stock | |
| (1,052,057 | ) |
Balance at September 30, 2023 | |
$ | — | |
In
May 2023, the Akos Series A Preferred Stock was redeemed for a total of $1,052,057, and the balance of the redeemable non-controlling
interest is $0 as of September 30, 2023.
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v3.23.3
COMMITMENTS AND CONTINGENCIES
|
9 Months Ended |
Sep. 30, 2023 |
Commitments and Contingencies Disclosure [Abstract] |
|
COMMITMENTS AND CONTINGENCIES |
NOTE
9. COMMITMENTS AND CONTINGENCIES
The
Company is periodically involved in legal proceedings, legal actions and claims arising in the normal course of business. Management
believes that the outcome of such legal proceedings, legal actions and claims will not have a significant adverse effect on the Company’s
financial position, results of operations or cash flows.
Australian
Subsidiary Research and Development
On
March 23, 2023, the Company issued a press release announcing the selection of Australian CRO, Avance Clinical, in preparation for Phase
1 Study of EB-373, the Company’s lead candidate targeting the treatment of anxiety disorders. Under the agreement, Avance Clinical
will manage the Phase 1 clinical trial of EB-373 in coordination with the Company’s newly established Australian subsidiary, Enveric
Therapeutics Pty, Ltd. The Phase 1 clinical trial is designed as a multi-cohort, dose-ascending study to measure the safety and tolerability
of EB-373. EB-373, a next-generation proprietary psilocin prodrug, has been recognized as a New Chemical Entity (NCE) by Australia’s
Therapeutic Goods Administration (TGA) and is currently in preclinical development targeting the treatment of anxiety disorder. The total
cost of the Avance Clinical contract is approximately 3,000,000 AUD, which translates to approximately $2,000,000 USD as of September
30, 2023. As of September 30, 2023, the Company has paid approximately $950,997 of the Avance Clinical contract costs and has $549,713
recorded as prepaid assets within prepaid and other current assets on the accompanying condensed consolidated balance sheet. For the
three and nine months ended September 30, 2023, the Company has expensed $157,117 and $401,284 in research and development expenses,
respectively, within the accompanying condensed consolidated statement of operations.
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Development
and Clinical Supply Agreement
On
February 22, 2021, the Company entered into a Development and Clinical Supply Agreement (the “PureForm Agreement”) with PureForm
Global, Inc. (“PureForm”), pursuant to which PureForm will be the exclusive provider of synthetic cannabidiol (“API”)
for the Company’s development plans for cancer treatment and supportive care. Under the terms of the PureForm Agreement, PureForm
has granted the Company the exclusive right to purchase API and related product for cancer treatment and supportive care during the term
of the Agreement (contingent upon an initial minimum order of 1 kilogram during the first thirty (30) days from the effective date) and
has agreed to manufacture, package and test the API and related product in accordance with specifications established by the parties.
All inventions that are developed jointly by the parties in the course of performing activities under the PureForm Agreement will be
owned jointly by the parties in accordance with applicable law; however, if the Company funds additional research and development efforts
by PureForm, the parties may enter into a further agreement whereby PureForm would assign any resulting inventions or technical information
to the Company.
The
initial term of the PureForm Agreement is three (3) years commencing on the effective date of the PureForm Agreement, subject to extension
by mutual agreement of the parties. The PureForm Agreement may be terminated by either party upon thirty (30) days written notice of
an uncured material breach or immediately in the event of bankruptcy or insolvency. The PureForm Agreement contains, among other provisions,
representation and warranties, indemnification obligations and confidentiality provisions in favor of each party that are customary for
an agreement of this nature.
The
Company has met the minimum purchase requirement of 1 kilogram during the first thirty days of the PureForm Agreement’s effectiveness.
Purchase
agreement with Prof. Zvi Vogel and Dr. Ilana Nathan
On
December 26, 2017, Jay Pharma entered into a purchase agreement with Prof. Zvi Vogel and Dr. Ilana Nathan (the “Vogel-Nathan Purchase
Agreement”), pursuant to which Jay Pharma was assigned ownership rights to certain patents, which were filed and unissued as of
the date of the Vogel-Nathan Purchase Agreement. The Vogel-Nathan Purchase Agreement includes a commitment to pay a one-time milestone
totaling $200,000 upon the issuance of a utility patent in the United States or by the European Patent Office, as defined in the agreement.
The Company has accrued such amount as of December 31, 2021, as a result of the milestone criteria being achieved. Payment was made during
January 2022. In addition, a milestone payment totaling $300,000 is due upon initiation of a Phase II(b) study. Research activities related
to the relevant patents are still in pre-clinical stage, and accordingly, this milestone has not been achieved. The Vogel-Nathan Purchase
Agreement contains a commitment for payment of royalties equaling 2% of the first $20 million in net sales derived from the commercialization
of products utilizing the relevant patent. As these products are still in the preclinical phase of development, no royalties have been
earned.
Other
Consulting and Vendor Agreements
The
Company has entered into a number of agreements and work orders for future consulting, clinical trial support, and testing services,
with terms ranging between 1 and 18 months. These agreements, in aggregate, commit the Company to approximately $1.2 million in future
cash payments.
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v3.23.3
SUBSEQUENT EVENTS
|
9 Months Ended |
Sep. 30, 2023 |
Subsequent Events [Abstract] |
|
SUBSEQUENT EVENTS |
NOTE
10. SUBSEQUENT EVENTS
Lincoln
Park Equity Line
On
November 3, 2023, the Company entered into a Purchase Agreement and a registration rights agreement (the “Registration Rights Agreement”),
with Lincoln Park, pursuant to which Lincoln Park has committed to purchase up to $10.0 million of the Company’s common stock,
par value $0.01 per share subject to certain limitations and satisfaction of the conditions set forth in the Purchase Agreement.
Under
the terms and subject to the conditions of the Purchase Agreement, the Company has the right, but not the obligation, to sell to Lincoln
Park, and Lincoln Park is obligated to purchase up to $10.0 million of the Company’s Common Stock (the “Purchase Shares”).
However, such sales of Common Stock by the Company, if any, will be subject to important limitations set forth in the Purchase Agreement,
including limitations on number of shares that may be sold. Sales may occur from time to time, at the Company’s sole discretion,
over the 24-month period commencing on the date that the conditions to Lincoln Park’s purchase obligation set forth in the Purchase
Agreement are satisfied, including that a registration statement on Form S-1 covering the resale of the shares of our Common Stock that
have been and may be issued to Lincoln Park under the Purchase Agreement, which the Company has filed with the SEC pursuant to the Registration
Rights Agreement, is declared effective by the SEC and a final prospectus relating thereto is filed with the SEC.
Because
the purchase price per share to be paid by Lincoln Park for the shares of Common Stock that we may elect to sell to Lincoln Park under
the Purchase Agreement, if any, will fluctuate based on the market prices of our Common Stock at the time we elect to sell shares to
Lincoln Park pursuant to the Purchase Agreement, if any, it is not possible for us to predict the number of shares of Common Stock that
we will sell to Lincoln Park under the Purchase Agreement, the purchase price per share that Lincoln Park will pay for shares purchased
from us under the Purchase Agreement, or the aggregate gross proceeds that we will receive from those purchases by Lincoln Park under
the Purchase Agreement.
For
additional details, please refer to the Company’s Current Report on Form 8-K filed with the SEC on November 6, 2023.
2020
Long-Term Incentive Plan Amended
On
November 2, 2023, the shareholders approved the amendments to the 2020 Long-Term Incentive Plan, which was approved by the Board on August
8, 2023 (the “Amended Incentive Plan”). The Amended Incentive Plan increased the number of authorized shares reserved for
issuance under the Amended Incentive Plan to a maximum of 350,000, subject to adjustment.
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v3.23.3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)
|
9 Months Ended |
Sep. 30, 2023 |
Accounting Policies [Abstract] |
|
Basis of Presentation and Principal of Consolidation |
Basis
of Presentation and Principal of Consolidation
The
accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally
accepted in the United States (“U.S. GAAP”) for interim financial information and Article 8 of Regulation S-X. Accordingly,
they do not include all the information and footnotes required by U.S. GAAP for complete financial statements. Management’s opinion
is that all adjustments (consisting of normal accruals) considered necessary for a fair presentation have been included. Operating results
for the three and nine months ended September 30, 2023 are not necessarily indicative of the results that may be expected for the year
ending December 31, 2023. These unaudited condensed consolidated financial statements should be read in conjunction with the consolidated
financial statements for the year ended December 31, 2022, and related notes thereto included in the Company’s Annual Report on
Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on March 31, 2023 and subsequently amended on Form
10-K/A Amendment No. 1 filed with the SEC on June 9, 2023 (as amended, the “Annual Report”).
The
Company’s significant accounting policies and recent accounting standards are summarized in Note 2 of the Company’s consolidated
financial statements for the year ended December 31, 2022. There were no significant changes to these accounting policies during the
three and nine months ended September 30, 2023.
|
Use of Estimates |
Use
of Estimates
The
preparation of the unaudited condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates
and assumptions that affect the reported amount of assets and liabilities at the date of the financial statements and expenses during
the periods reported. By their nature, these estimates are subject to measurement uncertainty and the effects on the financial statements
of changes in such estimates in future periods could be significant. Significant areas requiring management’s estimates and assumptions
include determining the fair value of transactions involving common stock and the valuation of stock-based compensation, accruals associated
with third party providers supporting research and development efforts, and estimated fair values of long lived assets used to record
impairment charges related to intangible assets. Actual results could differ from those estimates.
|
Foreign Currency Translation |
Foreign
Currency Translation
From
inception through September 30, 2023, the reporting currency of the Company was the United States dollar while the functional currency
of certain of the Company’s subsidiaries was the Canadian dollar and Australian dollar. For the reporting periods ended September
30, 2023 and 2022, the Company engaged in a number of transactions denominated in Canadian dollars and Australian dollars. As a result,
the Company is subject to exposure from changes in the exchange rates of the Canadian dollar and Australian dollar against the United
States dollar.
The
Company translates the assets and liabilities of its Canadian subsidiaries and Australian subsidiary into the United States dollar at
the exchange rate in effect on the balance sheet date. Revenues and expenses are translated at the average exchange rate in effect during
each monthly period. Unrealized translation gains and losses are recorded as foreign currency translation gain (loss), which is included
in the condensed consolidated statements of shareholders’ equity as a component of accumulated other comprehensive loss.
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
The
Company has not entered into any financial derivative instruments that expose it to material market risk, including any instruments designed
to hedge the impact of foreign currency exposures. The Company may, however, hedge such exposure to foreign currency exchange fluctuations
in the future.
Adjustments
that arise from exchange rate changes on transactions denominated in a currency other than the local currency are included in other comprehensive
loss in the condensed consolidated statements of operations and comprehensive loss as incurred.
|
Concentration of Credit Risk |
Concentration
of Credit Risk
Financial
instruments that potentially subject the Company to concentrations of credit risk consist of cash accounts in a financial institution,
which at times, may exceed the federal depository insurance coverage of $250,000 in the United States and Australia and $100,000 in Canada.
The Company has not experienced losses on these accounts, and management believes the Company is not exposed to significant risks on
such accounts. As of September 30, 2023, the Company had greater than $250,000 at United States financial institutions, less than $250,000
at Australian financial institutions, and greater than $100,000 at Canadian financial institutions.
|
Deferred Offering Costs |
Deferred
Offering Costs
The
Company complies with the requirements of ASC Topic 340, Other Assets and Deferred Costs (“ASC 340”) and SAB 5A -
Expenses of Offering. Offering costs, which consist mainly of legal, accounting and consulting fees directly attributable to the
issuance of an equity contract to be classified in equity are recorded as a reduction in equity. During September 2023, the Company incurred
$125,800 in deferred offering costs in connection with the Equity Distribution Agreement (the “Distribution Agreement”),
with Canaccord Genuity LLC (“Canaccord”) and the Purchase Agreement (the “Purchase Agreement”) with Lincoln Park
Capital Fund, LLC (“Lincoln Park”). These deferred offering costs will be proportionately offset against the total proceeds
from the issuance of common stock available under the agreements and the Company will expense any remaining balance of deferred offering
costs if the agreements are terminated. For the three and nine months ended September 30, 2023, there were no issuances of common stock
under the agreements resulting in the deferral of offering costs.
|
Warrant Liability and Investment Options |
Warrant
Liability and Investment Options
The
Company evaluates all of its financial instruments, including issued stock purchase warrants and investment options, to determine if
such instruments are derivatives or contain features that qualify as embedded derivatives, pursuant to ASC 480 “Distinguishing
Liabilities from Equity” (“ASC 480”) and FASB ASC Topic 815, “Derivatives and Hedging” (“ASC 815”).
The Company accounts for warrants and investment options for shares of the Company’s common stock that are not indexed to its own
stock as derivative liabilities at fair value on the unaudited condensed consolidated balance sheets. The Company accounts for common
stock warrants and investment options with put options as liabilities under ASC 480. Such warrants and investment options are subject
to remeasurement at each unaudited condensed consolidated balance sheet date and any change in fair value is recognized as a component
of other expense on the unaudited condensed consolidated statements of operations. The Company will continue to adjust the liability
for changes in fair value until the earlier of the exercise or expiration of such common stock warrants and investment options. At that
time, the portion of the warrant liability and investment options related to such common stock warrants will be reclassified to additional
paid-in capital.
|
Derivative Liability |
Derivative
Liability
The
Company evaluates its financial instruments to determine if such instruments are derivatives or contain features that qualify as embedded
derivatives in accordance with ASC 815. For derivative financial instruments that are accounted for as assets or liabilities, the derivative
instrument is initially recorded at its fair value on the grant date and is then re-valued at each reporting date, with changes in the
fair value reported in the unaudited condensed consolidated statements of operations. The classification of derivative instruments, including
whether such instruments should be recorded as assets or liabilities or as equity, is evaluated at the end of each reporting period.
Derivative liabilities are classified in the unaudited condensed consolidated balance sheets as current or non-current based on whether
or not net-cash settlement or conversion of the instrument could be required within 12 months of the balance sheet date.
|
Income Taxes |
Income
Taxes
The
Company files U.S. federal and state returns. The Company’s foreign subsidiary also files a local tax return in their local jurisdiction.
From a U.S. federal, state, and Canadian perspective, the years that remain open to examination are consistent with each jurisdiction’s
statute of limitations.
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
|
Net Loss per Share |
Net
Loss per Share
Basic
net loss per share is computed by dividing net loss by the weighted average number of shares of common stock outstanding during the period.
Diluted earnings per share is computed using the weighted average number of common shares and, if dilutive, potential common shares outstanding
during the period. Potential common shares consist of the incremental common shares issuable upon the exercise of stock options and warrants
(using the treasury stock method). The computation of basic net loss per share for the three and nine months ended September 30, 2023
and 2022 excludes potentially dilutive securities. The computations of net loss per share for each period presented is the same for both
basic and fully diluted. In accordance with ASC 260 “Earnings per Share” (“ASC 260”), penny warrants were included
in the calculation of weighted average shares outstanding for the purposes of calculating basic and diluted earnings per share.
Potentially
dilutive securities outlined in the table below have been excluded from the computation of diluted net loss per share the three and nine
months ended September 30, 2023 and 2022 because the effect of their inclusion would have been anti-dilutive.
SCHEDULE
OF POTENTIALLY DILUTIVE SECURITIES
| |
For the three and nine months ended September 30, 2023 | | |
For the three and nine months ended September 30, 2022 | |
Warrants to purchase shares of common stock | |
| 609,893 | | |
| 655,463 | |
Restricted stock units - vested and unissued | |
| 20,847 | | |
| 61,428 | |
Restricted stock units - unvested | |
| 148,251 | | |
| 65,117 | |
Restricted stock awards - vested and unissued | |
| — | | |
| 974 | |
Investment options to purchase shares of common stock | |
| 1,070,000 | | |
| 1,070,000 | |
Options to purchase shares of common stock | |
| 31,852 | | |
| 22,829 | |
Total potentially dilutive securities | |
| 1,880,843 | | |
| 1,875,811 | |
|
Fair Value Measurements |
Fair
Value Measurements
Fair
value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between
market participants at the measurement date. To increase the comparability of fair value measures, the following hierarchy prioritizes
the inputs to valuation methodologies used to measure fair value:
Level
1 - Valuations based on quoted prices for identical assets and liabilities in active markets.
Level
2 - Valuations based on observable inputs other than quoted prices included in Level 1, such as quoted prices for similar assets and
liabilities in active markets, quoted prices for identical or similar assets and liabilities in markets that are not active, or other
inputs that are observable or can be corroborated by observable market data.
Level
3 - Valuations based on unobservable inputs reflecting our own assumptions, consistent with reasonably available assumptions made by
other market participants. These valuations require significant judgment.
For
certain financial instruments, including cash and accounts payable, the carrying amounts approximate their fair values as of September
30, 2023, and December 31, 2022 because of their short-term nature.
The
following table provides the financial liabilities measured on a recurring basis and reported at fair value on the balance sheet as of
September 30, 2023, and December 31, 2022, and indicates the fair value of the valuation inputs the Company utilized to determine such
fair value of warrant liabilities, derivative liability, and investment options:
SCHEDULE
OF FAIR VALUE HIERARCHY OF VALUATION INPUTS ON RECURRING BASIS
| |
Level | |
September 30, 2023 | | |
December 31, 2022 | |
Warrant liabilities - January 2021 Warrants | |
3 | |
$ | 18 | | |
$ | 81 | |
Warrant liabilities - February 2021 Warrants | |
3 | |
| 59 | | |
| 79 | |
Warrant liabilities - February 2022 Warrants | |
3 | |
| 300,480 | | |
| 185,055 | |
Fair value of warrant liability | |
| |
$ | 300,557 | | |
$ | 185,215 | |
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
| |
Level | |
September 30, 2023 | | |
December 31, 2022 | |
Derivative liability - May 2022 | |
3 | |
$ | — | | |
$ | 727,000 | |
Fair value of derivative liability | |
| |
$ | — | | |
$ | 727,000 | |
| |
Level | |
September 30, 2023 | | |
December 31, 2022 | |
H.C. Wainwright & Co., LLC investment options | |
3 | |
$ | 70,521 | | |
$ | 44,904 | |
RD investment options | |
3 | |
| 442,653 | | |
| 302,289 | |
PIPE investment options | |
3 | |
| 737,755 | | |
| 503,815 | |
Fair value of investment option liability | |
| |
$ | 1,250,929 | | |
$ | 851,008 | |
The
warrant liabilities, derivative liability, and investment options are all classified as Level 3, for which there is no current market
for these securities such as the determination of fair value requires significant judgment or estimation. Changes in fair value measurement
categorized within Level 3 of the fair value hierarchy are analyzed each period based on changes in estimates or assumptions and recorded
within other income (expense) on the condensed consolidated statements of operations and comprehensive loss.
Subsequent
measurement
The
following table presents the changes in fair value of the warrant liabilities, derivative liability, and investment options that are
classified as Level 3:
SCHEDULE
OF FAIR VALUE OF WARRANT LIABILITIES AND DERIVATIVE LIABILITY AND INVESTMENT OPTIONS
| |
Total Warrant Liabilities | |
Fair value as of December 31, 2022 | |
$ | 185,215 | |
Change in fair value | |
| 115,342 | |
Fair value as of September 30, 2023 | |
$ | 300,557 | |
| |
Total Derivative Liability | |
Fair value as of December 31, 2022 | |
$ | 727,000 | |
Change in fair value arising from redemption of Akos Series A Preferred Stock - See Note 8 | |
| (727,000 | ) |
Fair value of derivative liability as of September 30, 2023 | |
$ | — | |
| |
Total Investment Option Liability | |
Fair value as of December 31, 2022 | |
$ | 851,008 | |
Change in fair value | |
| 399,921 | |
Fair value of investment option liability as of September 30, 2023 | |
$ | 1,250,929 | |
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
The
key inputs into the Black Scholes valuation model for the Level 3 valuations of the warrant liabilities as of September 30, 2023 are
below:
SCHEDULE
OF BLACK SCHOLES VALUATION MODELS OF WARRANT LIABILITIES AND INVESTMENT OPTIONS
| |
January 2021 Warrants | | |
February 2021 Warrants | | |
February 2022 Warrants | | |
February 2022 Post-Modification Warrants | |
Term (years) | |
| 2.3 | | |
| 2.4 | | |
| 3.4 | | |
| 4.3 | |
Stock price | |
$ | 2.38 | | |
$ | 2.38 | | |
$ | 2.38 | | |
$ | 2.38 | |
Exercise price | |
$ | 247.50 | | |
$ | 245.00 | | |
$ | 27.50 | | |
$ | 7.78 | |
Dividend yield | |
| — | % | |
| — | % | |
| — | % | |
| — | % |
Expected volatility | |
| 80.0 | % | |
| 85.0 | % | |
| 96.0 | % | |
| 94.0 | % |
Risk free interest rate | |
| 5.00 | % | |
| 4.90 | % | |
| 4.80 | % | |
| 4.70 | % |
Number of warrants | |
| 36,429 | | |
| 34,281 | | |
| 338,000 | | |
| 122,000 | |
Value (per share) | |
$ | — | | |
$ | — | | |
$ | 0.46 | | |
$ | 1.18 | |
The
key inputs into the Black Scholes valuation model for the Level 3 valuations of the investment options as of September 30, 2023 are below:
| |
H.C. Wainwright & Co., LLC Options | | |
RD Offering Options | | |
PIPE Offering Options | |
Term (years) | |
| 3.8 | | |
| 4.3 | | |
| 4.3 | |
Stock price | |
$ | 2.38 | | |
$ | 2.38 | | |
$ | 2.38 | |
Exercise price | |
$ | 10.00 | | |
$ | 7.78 | | |
$ | 7.78 | |
Dividend yield | |
| — | % | |
| — | % | |
| — | % |
Expected volatility | |
| 97.0 | % | |
| 94.0 | % | |
| 94.0 | % |
Risk free interest rate | |
| 4.70 | % | |
| 4.70 | % | |
| 4.70 | % |
Number of investment options | |
| 70,000 | | |
| 375,000 | | |
| 625,000 | |
Value (per share) | |
$ | 1.01 | | |
$ | 1.18 | | |
$ | 1.18 | |
The
key inputs into the Weighted Expected Return valuation model for the Level 3 valuations of the derivative liability as of redemption,
are below:
| |
| May 2022 Derivative Liability | |
Principal | |
$ | — | |
Dividend rate | |
| — | % |
Market rate | |
| — | % |
At
the date of the redemption of the of Akos Series A Preferred Stock in May 2023, the derivative liability fair value was $0 due to the
probability of a spin-off occurring was zero. See Note 8
|
Redeemable Non-controlling Interest |
Redeemable
Non-controlling Interest
In
connection with the issuance of Akos Series A Preferred Stock, the Akos Purchase Agreement (as defined below in Note 8) and certificate
of designation contain a put right guaranteed by the Company as defined in Note 8. Applicable accounting guidance requires an equity
instrument that is redeemable for cash or other assets to be classified outside of permanent equity if it is redeemable (a) at a fixed
or determinable price on a fixed or determinable date, (b) at the option of the holder, or (c) upon the occurrence of an event that is
not solely within the control of the issuer. As a result of this feature, the Company recorded the non-controlling interests as redeemable
non-controlling interests and classified them in mezzanine equity within its unaudited condensed consolidated balance sheet initially
at its acquisition-date estimated redemption value or fair value. In addition, the Company has elected to recognize changes in the redemption
value immediately as they occur and adjust the carrying amount of the instrument by accreting the embedded derivative at each reporting
period over 12 months.
In
May 2023, pursuant to the Akos Series A Preferred Certificate of Designations, the holders of the Akos Series A Preferred Stock exercised
the Put Right (as defined below) requiring Akos to force redemption of all of the Akos Series A Preferred Stock. See Note 8.
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
|
Segment Reporting |
Segment
Reporting
The
Company determines its reporting units in accordance with FASB ASC 280, “Segment Reporting” (“ASC 280”). The
Company evaluates a reporting unit by first identifying its operating segments under ASC 280. The Company then evaluates each operating
segment to determine if it includes one or more components that constitute a business. If there are components within an operating segment
that meet the definition of a business, the Company evaluates those components to determine if they must be aggregated into one or more
reporting units. If applicable, when determining if it is appropriate to aggregate different operating segments, the Company determines
if the segments are economically similar and, if so, the operating segments are aggregated. The Company has multiple operations related
to psychedelics and cannabinoids. Both of these operations exist under one reporting unit: Enveric. The Company has one operating segment
and reporting unit. The Company is organized and operated as one business. Management reviews its business as a single operating segment,
using financial and other information rendered meaningful only by the fact that such information is presented and reviewed in the aggregate.
|
Recent Accounting Pronouncements |
Recent
Accounting Pronouncements
In
August 2020, the FASB issued ASU 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives
and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40) (“ASU 2020-06”) to simplify certain financial
instruments. ASU 2020-06 eliminates the current models that require separation of beneficial conversion and cash conversion features
from convertible instruments and simplifies the derivative scope exception guidance pertaining to equity classification of contracts
in an entity’s own equity. The new standard also introduces additional disclosures for convertible debt and freestanding instruments
that are indexed to and settled in an entity’s own equity. ASU 2020-06 amends the diluted earnings per share guidance, including
the requirement to use the if-converted method for all convertible instruments. ASU 2020-06 is effective for fiscal years beginning after
December 15, 2023, and should be applied on a full or modified retrospective basis. Early adoption is permitted, but no earlier than
fiscal years beginning after December 15, 2020, including interim periods within those fiscal years. The Company early adopted ASU 2020-06
effective January 1, 2023, and has determined that the adoption of this guidance had no impact on its condensed consolidated financial
statements.
|
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v3.23.3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
SCHEDULE OF POTENTIALLY DILUTIVE SECURITIES |
Potentially
dilutive securities outlined in the table below have been excluded from the computation of diluted net loss per share the three and nine
months ended September 30, 2023 and 2022 because the effect of their inclusion would have been anti-dilutive.
SCHEDULE
OF POTENTIALLY DILUTIVE SECURITIES
| |
For the three and nine months ended September 30, 2023 | | |
For the three and nine months ended September 30, 2022 | |
Warrants to purchase shares of common stock | |
| 609,893 | | |
| 655,463 | |
Restricted stock units - vested and unissued | |
| 20,847 | | |
| 61,428 | |
Restricted stock units - unvested | |
| 148,251 | | |
| 65,117 | |
Restricted stock awards - vested and unissued | |
| — | | |
| 974 | |
Investment options to purchase shares of common stock | |
| 1,070,000 | | |
| 1,070,000 | |
Options to purchase shares of common stock | |
| 31,852 | | |
| 22,829 | |
Total potentially dilutive securities | |
| 1,880,843 | | |
| 1,875,811 | |
|
SCHEDULE OF FAIR VALUE HIERARCHY OF VALUATION INPUTS ON RECURRING BASIS |
The
following table provides the financial liabilities measured on a recurring basis and reported at fair value on the balance sheet as of
September 30, 2023, and December 31, 2022, and indicates the fair value of the valuation inputs the Company utilized to determine such
fair value of warrant liabilities, derivative liability, and investment options:
SCHEDULE
OF FAIR VALUE HIERARCHY OF VALUATION INPUTS ON RECURRING BASIS
| |
Level | |
September 30, 2023 | | |
December 31, 2022 | |
Warrant liabilities - January 2021 Warrants | |
3 | |
$ | 18 | | |
$ | 81 | |
Warrant liabilities - February 2021 Warrants | |
3 | |
| 59 | | |
| 79 | |
Warrant liabilities - February 2022 Warrants | |
3 | |
| 300,480 | | |
| 185,055 | |
Fair value of warrant liability | |
| |
$ | 300,557 | | |
$ | 185,215 | |
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
| |
Level | |
September 30, 2023 | | |
December 31, 2022 | |
Derivative liability - May 2022 | |
3 | |
$ | — | | |
$ | 727,000 | |
Fair value of derivative liability | |
| |
$ | — | | |
$ | 727,000 | |
| |
Level | |
September 30, 2023 | | |
December 31, 2022 | |
H.C. Wainwright & Co., LLC investment options | |
3 | |
$ | 70,521 | | |
$ | 44,904 | |
RD investment options | |
3 | |
| 442,653 | | |
| 302,289 | |
PIPE investment options | |
3 | |
| 737,755 | | |
| 503,815 | |
Fair value of investment option liability | |
| |
$ | 1,250,929 | | |
$ | 851,008 | |
|
Subsequent Measurement [Member] |
|
SCHEDULE OF FAIR VALUE OF WARRANT LIABILITIES AND DERIVATIVE LIABILITY AND INVESTMENT OPTIONS |
The
following table presents the changes in fair value of the warrant liabilities, derivative liability, and investment options that are
classified as Level 3:
SCHEDULE
OF FAIR VALUE OF WARRANT LIABILITIES AND DERIVATIVE LIABILITY AND INVESTMENT OPTIONS
| |
Total Warrant Liabilities | |
Fair value as of December 31, 2022 | |
$ | 185,215 | |
Change in fair value | |
| 115,342 | |
Fair value as of September 30, 2023 | |
$ | 300,557 | |
| |
Total Derivative Liability | |
Fair value as of December 31, 2022 | |
$ | 727,000 | |
Change in fair value arising from redemption of Akos Series A Preferred Stock - See Note 8 | |
| (727,000 | ) |
Fair value of derivative liability as of September 30, 2023 | |
$ | — | |
| |
Total Investment Option Liability | |
Fair value as of December 31, 2022 | |
$ | 851,008 | |
Change in fair value | |
| 399,921 | |
Fair value of investment option liability as of September 30, 2023 | |
$ | 1,250,929 | |
|
SCHEDULE OF BLACK SCHOLES VALUATION MODELS OF WARRANT LIABILITIES AND INVESTMENT OPTIONS |
The
key inputs into the Black Scholes valuation model for the Level 3 valuations of the warrant liabilities as of September 30, 2023 are
below:
SCHEDULE
OF BLACK SCHOLES VALUATION MODELS OF WARRANT LIABILITIES AND INVESTMENT OPTIONS
| |
January 2021 Warrants | | |
February 2021 Warrants | | |
February 2022 Warrants | | |
February 2022 Post-Modification Warrants | |
Term (years) | |
| 2.3 | | |
| 2.4 | | |
| 3.4 | | |
| 4.3 | |
Stock price | |
$ | 2.38 | | |
$ | 2.38 | | |
$ | 2.38 | | |
$ | 2.38 | |
Exercise price | |
$ | 247.50 | | |
$ | 245.00 | | |
$ | 27.50 | | |
$ | 7.78 | |
Dividend yield | |
| — | % | |
| — | % | |
| — | % | |
| — | % |
Expected volatility | |
| 80.0 | % | |
| 85.0 | % | |
| 96.0 | % | |
| 94.0 | % |
Risk free interest rate | |
| 5.00 | % | |
| 4.90 | % | |
| 4.80 | % | |
| 4.70 | % |
Number of warrants | |
| 36,429 | | |
| 34,281 | | |
| 338,000 | | |
| 122,000 | |
Value (per share) | |
$ | — | | |
$ | — | | |
$ | 0.46 | | |
$ | 1.18 | |
The
key inputs into the Black Scholes valuation model for the Level 3 valuations of the investment options as of September 30, 2023 are below:
| |
H.C. Wainwright & Co., LLC Options | | |
RD Offering Options | | |
PIPE Offering Options | |
Term (years) | |
| 3.8 | | |
| 4.3 | | |
| 4.3 | |
Stock price | |
$ | 2.38 | | |
$ | 2.38 | | |
$ | 2.38 | |
Exercise price | |
$ | 10.00 | | |
$ | 7.78 | | |
$ | 7.78 | |
Dividend yield | |
| — | % | |
| — | % | |
| — | % |
Expected volatility | |
| 97.0 | % | |
| 94.0 | % | |
| 94.0 | % |
Risk free interest rate | |
| 4.70 | % | |
| 4.70 | % | |
| 4.70 | % |
Number of investment options | |
| 70,000 | | |
| 375,000 | | |
| 625,000 | |
Value (per share) | |
$ | 1.01 | | |
$ | 1.18 | | |
$ | 1.18 | |
The
key inputs into the Weighted Expected Return valuation model for the Level 3 valuations of the derivative liability as of redemption,
are below:
| |
| May 2022 Derivative Liability | |
Principal | |
$ | — | |
Dividend rate | |
| — | % |
Market rate | |
| — | % |
|
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- DefinitionTabular disclosure of input and valuation technique used to measure fair value and change in valuation approach and technique for each separate class of asset and liability measured on recurring and nonrecurring basis.
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v3.23.3
PREPAID EXPENSES AND OTHER CURRENT ASSETS (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] |
|
SCHEDULE OF PREPAID EXPENSES AND OTHER CURRENT ASSETS |
As
of September 30, 2023 and December 31, 2022, the prepaid expenses and other current assets of the Company consisted of the following:
SCHEDULE
OF PREPAID EXPENSES AND OTHER CURRENT ASSETS
| |
September 30, 2023 | | |
December 31, 2022 | |
Prepaid research and development | |
$ | 651,623 | | |
$ | 268,686 | |
Prepaid value-added taxes | |
| 229,909 | | |
| 159,782 | |
Prepaid professional fees | |
| 74,500 | | |
| — | |
Prepaid insurance | |
| 332,508 | | |
| 174,406 | |
Prepaid other | |
| 146,014 | | |
| 105,179 | |
Deferred offering costs | |
| 125,800 | | |
| — | |
Total prepaid expenses and other current assets | |
$ | 1,560,354 | | |
$ | 708,053 | |
|
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v3.23.3
PROPERTY AND EQUIPMENT (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Property, Plant and Equipment [Abstract] |
|
SCHEDULE OF PROPERTY PLANT AND EQUIPMENT NET OF ACCUMULATED DEPRECIATION |
Property
and equipment consists of the following assets which are located in Calgary, Canada and placed in service by Enveric Biosciences Canada,
Inc. (“EBCI”), with all amounts translated into U.S. dollars:
SCHEDULE OF PROPERTY PLANT AND EQUIPMENT NET OF ACCUMULATED DEPRECIATION
| |
September 30, 2023 | | |
December 31, 2022 | |
Lab equipment | |
$ | 818,460 | | |
$ | 831,123 | |
Computer equipment and leasehold improvements | |
| 27,759 | | |
| 25,137 | |
Less: Accumulated depreciation | |
| (307,067 | ) | |
| (178,775 | ) |
Property and equipment, net of accumulated depreciation | |
$ | 539,152 | | |
$ | 677,485 | |
|
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v3.23.3
ACCRUED LIABILITIES (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Payables and Accruals [Abstract] |
|
SCHEDULE OF ACCRUED LIABILITIES |
As
of September 30, 2023 and December 31, 2022, the accrued liabilities of the Company consisted of the following:
SCHEDULE
OF ACCRUED LIABILITIES
| |
September 30, 2023 | | |
December 31, 2022 | |
Product development | |
$ | 94,663 | | |
$ | 195,104 | |
Accrued salaries and wages | |
| 729,616 | | |
| 1,175,963 | |
Professional fees | |
| 74,499 | | |
| 83,255 | |
Accrued restructuring costs | |
| 607,602 | | |
| — | |
Accrued franchise taxes | |
| 9,449 | | |
| — | |
Patent costs | |
| 18,000 | | |
| 251,333 | |
Total accrued expenses | |
$ | 1,533,829 | | |
$ | 1,705,655 | |
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v3.23.3
SHARE CAPITAL AND OTHER EQUITY INSTRUMENTS (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Equity [Abstract] |
|
SCHEDULE OF STOCK OPTION |
A
summary of activity under the Company’s incentive plan for the nine months ended September 30, 2023, is presented below:
SCHEDULE OF STOCK OPTION
| |
Number of Shares | | |
Weighted Average Exercise Price | | |
Weighted Average Grant Date Fair Value | | |
Weighted Average Remaining Contractual Term (years) | | |
Aggregate Intrinsic Value | |
Outstanding at December 31, 2022 | |
| 48,329 | | |
$ | 37.05 | | |
$ | 44.82 | | |
| 4.1 | | |
$ | — | |
Forfeited | |
| (16,476 | ) | |
$ | 5.79 | | |
$ | 5.80 | | |
| — | | |
$ | — | |
Outstanding at September 30, 2023 | |
| 31,852 | | |
$ | 53.18 | | |
$ | 74.04 | | |
| 3.4 | | |
$ | — | |
Exercisable at September 30, 2023 | |
| 24,626 | | |
$ | 63.72 | | |
$ | 86.52 | | |
| 3.0 | | |
$ | — | |
|
SCHEDULE OF RESTRICTED STOCK UNITS AND AWARDS ACTIVITY |
The
Company’s activity in restricted stock units was as follows for the nine months ended September 30, 2023:
SCHEDULE OF RESTRICTED STOCK UNITS AND AWARDS ACTIVITY
| |
Number of shares | | |
Weighted average
fair value | |
Non-vested at December 31, 2022 | |
| 64,053 | | |
$ | 92.57 | |
Granted | |
| 182,500 | | |
$ | 2.73 | |
Vested | |
| (62,636 | ) | |
$ | 19.80 | |
Forfeited | |
| (35,666 | ) | |
$ | 27.45 | |
Non-vested at September 30, 2023 | |
| 148,251 | | |
$ | 28.39 | |
|
SCHEDULE OF STOCK-BASED COMPENSATION FOR RESTRICTED STOCK UNITS |
The
following table summarizes the Company’s recognition of stock-based compensation for restricted stock units for the following periods:
SCHEDULE OF STOCK-BASED COMPENSATION FOR RESTRICTED STOCK UNITS
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three months ended
September 30, | | |
Nine months ended
September 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Stock-based compensation expense for RSUs: | |
| | | |
| | | |
| | | |
| | |
General and administrative | |
$ | 101,607 | | |
$ | 357,756 | | |
$ | 946,851 | | |
$ | 1,138,080 | |
Research and development | |
| 226,646 | | |
| 232,434 | | |
| 691,514 | | |
| 794,473 | |
Total | |
$ | 328,253 | | |
$ | 590,190 | | |
$ | 1,638,365 | | |
$ | 1,932,553 | |
|
SCHEDULE OF WARRANTS OUTSTANDING |
The
following table summarizes information about shares issuable under warrants outstanding on September 30, 2023:
SCHEDULE
OF WARRANTS OUTSTANDING
| |
Warrant shares outstanding | | |
Weighted average exercise price | | |
Weighted average remaining life | | |
Intrinsic value | |
Outstanding at December 31, 2022 | |
| 655,463 | | |
$ | 58.36 | | |
| 3.6 | | |
$ | 5,514 | |
Expired | |
| (45,570 | ) | |
$ | 111.50 | | |
| — | | |
$ | — | |
Outstanding at September 30, 2023 | |
| 609,893 | | |
$ | 50.46 | | |
| 2.9 | | |
$ | — | |
Exercisable at September 30, 2023 | |
| 609,893 | | |
$ | 50.46 | | |
| 2.9 | | |
$ | — | |
|
SCHEDULE OF WARRANTS AND INVESTMENT OPTIONS |
The
following table summarizes information about investment options outstanding on September 30, 2023:
SCHEDULE
OF WARRANTS AND INVESTMENT OPTIONS
| |
Investment options outstanding | | |
Weighted average exercise price | | |
Weighted average remaining life | | |
Intrinsic value | |
Outstanding at December 31, 2022 | |
| 1,070,000 | | |
$ | 7.93 | | |
| 5.1 | | |
$ | — | |
Outstanding at September 30, 2023 | |
| 1,070,000 | | |
$ | 7.93 | | |
| 4.3 | | |
$ | — | |
Exercisable at September 30, 2023 | |
| 1,070,000 | | |
$ | 7.93 | | |
| 4.3 | | |
$ | — | |
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v3.23.3
REDEEMABLE NON-CONTROLLING INTEREST (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Redeemable Non-controlling Interest |
|
SCHEDULE OF RECONCILIATION CHANGE IN REDEEMABLE NONCONTROLLING INTEREST |
The
table below presents the reconciliation of changes in redeemable non-controlling interest:
SCHEDULE OF RECONCILIATION CHANGE IN REDEEMABLE NONCONTROLLING INTEREST
Balance at December 31, 2022 | |
$ | 885,028 | |
Preferred dividends attributable to redeemable non-controlling interest | |
| 19,041 | |
Accretion of embedded derivative and transaction costs associated with Akos Series A Preferred | |
| 147,988 | |
Redemption of Akos Series A Preferred Stock | |
| (1,052,057 | ) |
Balance at September 30, 2023 | |
$ | — | |
|
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v3.23.3
BUSINESS AND LIQUIDITY AND OTHER UNCERTAINTIES (Details Narrative) - USD ($)
|
|
|
1 Months Ended |
3 Months Ended |
9 Months Ended |
|
Jun. 16, 2023 |
May 12, 2023 |
May 31, 2023 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Dec. 31, 2022 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
|
Preferred stock, par value |
|
|
|
$ 0.01
|
|
$ 0.01
|
|
$ 0.01
|
Dividends |
|
$ 1,052,057
|
|
|
|
|
|
|
Accumulated deficit |
|
|
|
$ 93,063,582
|
|
$ 93,063,582
|
|
$ 79,207,786
|
Net cash used in operating activities |
|
|
|
|
|
12,343,363
|
$ 13,684,606
|
|
Loss from operations |
|
|
|
3,448,395
|
$ 5,656,849
|
14,064,080
|
$ 15,159,453
|
|
Cash |
|
|
|
4,266,568
|
|
4,266,568
|
|
$ 17,723,884
|
Working capital |
|
|
|
$ 1,643,374
|
|
1,643,374
|
|
|
Severance costs |
|
|
$ 453,059
|
|
|
|
|
|
Restricted Stock Units (RSUs) [Member] |
|
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
|
Market performance based shares |
11,278
|
|
|
|
|
|
|
|
Equity Distribution Agreement [Member] |
|
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
|
Additional working capital |
|
|
|
|
|
$ 2,400,000
|
|
|
Kanubaddi Separation Agreement [Member] |
|
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
|
Salaries and benefit |
$ 550,974
|
|
|
|
|
|
|
|
Mr Kanubaddi Employment Agreement [Member] | Restricted Stock Units (RSUs) [Member] |
|
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
|
Expense related to acceleration of vesting |
$ 231,273
|
|
|
|
|
|
|
|
Market performance based shares |
3,759
|
|
|
|
|
|
|
|
Series A Preferred Stock [Member] |
|
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
|
Preferred stock, par value |
|
$ 0.01
|
|
|
|
|
|
|
Dividends, per share |
|
$ 1,000
|
$ 1,000
|
|
|
|
|
|
Unpaid dividends |
|
$ 52,057
|
$ 52,000
|
|
|
|
|
|
Dividends |
|
|
$ 1,052,000
|
|
|
|
|
|
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v3.23.3
SCHEDULE OF POTENTIALLY DILUTIVE SECURITIES (Details) - shares
|
3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
|
Total potentially dilutive securities |
1,880,843
|
1,875,811
|
1,880,843
|
1,875,811
|
Warrants to Purchase Shares of Common Stock [Member] |
|
|
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
|
Total potentially dilutive securities |
609,893
|
655,463
|
609,893
|
655,463
|
Restricted Stock Units Vested and Unissued [Member] |
|
|
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
|
Total potentially dilutive securities |
20,847
|
61,428
|
20,847
|
61,428
|
Restricted Stock Units Unvested [Member] |
|
|
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
|
Total potentially dilutive securities |
148,251
|
65,117
|
148,251
|
65,117
|
Restricted Stock Awards Vested and Unissued [Member] |
|
|
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
|
Total potentially dilutive securities |
|
974
|
|
974
|
Investment Options to Purchase Shares of Common Stock [Member] |
|
|
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
|
Total potentially dilutive securities |
1,070,000
|
1,070,000
|
1,070,000
|
1,070,000
|
Options to Purchase Shares of Common Stock [Member] |
|
|
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
|
Total potentially dilutive securities |
31,852
|
22,829
|
31,852
|
22,829
|
X |
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v3.23.3
SCHEDULE OF FAIR VALUE HIERARCHY OF VALUATION INPUTS ON RECURRING BASIS (Details) - Fair Value, Inputs, Level 3 [Member] - Fair Value, Recurring [Member] - USD ($)
|
Sep. 30, 2023 |
Dec. 31, 2022 |
Class of Warrant or Right [Line Items] |
|
|
Fair value of warrant liability |
$ 300,557
|
$ 185,215
|
Fair value of derivative liability |
|
727,000
|
Fair value of investment option liability |
1,250,929
|
851,008
|
Derivative liability - May 2022 [Member] |
|
|
Class of Warrant or Right [Line Items] |
|
|
Fair value of derivative liability |
|
727,000
|
HC Wainwright and Co LLC Investment Options [Member] |
|
|
Class of Warrant or Right [Line Items] |
|
|
Fair value of investment option liability |
70,521
|
44,904
|
RD Investment Options [Member] |
|
|
Class of Warrant or Right [Line Items] |
|
|
Fair value of investment option liability |
442,653
|
302,289
|
PIPE Investment Options [Member] |
|
|
Class of Warrant or Right [Line Items] |
|
|
Fair value of investment option liability |
737,755
|
503,815
|
Warrant liabilities - January 2021 Warrants [Member] |
|
|
Class of Warrant or Right [Line Items] |
|
|
Fair value of warrant liability |
18
|
81
|
Warrant liabilities - February 2021 Warrants [Member] |
|
|
Class of Warrant or Right [Line Items] |
|
|
Fair value of warrant liability |
59
|
79
|
Warrant liabilities - February 2022 Warrants [Member] |
|
|
Class of Warrant or Right [Line Items] |
|
|
Fair value of warrant liability |
$ 300,480
|
$ 185,055
|
X |
- DefinitionLine items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.
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v3.23.3
SCHEDULE OF FAIR VALUE OF WARRANT LIABILITIES AND DERIVATIVE LIABILITY AND INVESTMENT OPTIONS (Details) - Fair Value, Inputs, Level 3 [Member]
|
9 Months Ended |
Sep. 30, 2023
USD ($)
|
Warrant [Member] |
|
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
Total beginning balance |
$ 185,215
|
Change in fair value |
115,342
|
Total ending balance |
300,557
|
Derivative [Member] |
|
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
Total beginning balance |
727,000
|
Change in fair value |
(727,000)
|
Total ending balance |
|
Options Held [Member] |
|
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
Total beginning balance |
851,008
|
Change in fair value |
399,921
|
Total ending balance |
$ 1,250,929
|
X |
- DefinitionLine items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.
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v3.23.3
SCHEDULE OF BLACK SCHOLES VALUATION MODELS OF WARRANT LIABILITIES AND INVESTMENT OPTIONS (Details) - Subsequent Measurement [Member]
|
9 Months Ended |
Sep. 30, 2023
USD ($)
$ / shares
shares
|
May Twenty Twenty Two Derivative Liability [Member] |
|
Principal | $ |
|
HC Wainwright and Co LLC Investment Options [Member] |
|
Value (per share) |
$ 1.01
|
Investment option term |
3 years 9 months 18 days
|
Number of investment options | shares |
70,000
|
RD Offering Investment Options [Member] |
|
Value (per share) |
$ 1.18
|
Investment option term |
4 years 3 months 18 days
|
Number of investment options | shares |
375,000
|
PIPE Offering Investment Options [Member] |
|
Value (per share) |
$ 1.18
|
Investment option term |
4 years 3 months 18 days
|
Number of investment options | shares |
625,000
|
Measurement Input, Share Price [Member] | HC Wainwright and Co LLC Investment Options [Member] |
|
Investment, stock price |
$ 2.38
|
Investment, exercise price |
10.00
|
Measurement Input, Share Price [Member] | RD Offering Investment Options [Member] |
|
Investment, stock price |
2.38
|
Investment, exercise price |
7.78
|
Measurement Input, Share Price [Member] | PIPE Offering Investment Options [Member] |
|
Investment, stock price |
2.38
|
Investment, exercise price |
$ 7.78
|
Measurement Input, Expected Dividend Rate [Member] | May Twenty Twenty Two Derivative Liability [Member] |
|
Investment, measurement input |
|
Measurement Input, Expected Dividend Rate [Member] | HC Wainwright and Co LLC Investment Options [Member] |
|
Investment, measurement input |
|
Measurement Input, Expected Dividend Rate [Member] | RD Offering Investment Options [Member] |
|
Investment, measurement input |
|
Measurement Input, Expected Dividend Rate [Member] | PIPE Offering Investment Options [Member] |
|
Investment, measurement input |
|
Measurement Input, Option Volatility [Member] | HC Wainwright and Co LLC Investment Options [Member] |
|
Investment, measurement input |
97.0
|
Measurement Input, Option Volatility [Member] | RD Offering Investment Options [Member] |
|
Investment, measurement input |
94.0
|
Measurement Input, Option Volatility [Member] | PIPE Offering Investment Options [Member] |
|
Investment, measurement input |
94.0
|
Measurement Input, Risk Free Interest Rate [Member] | HC Wainwright and Co LLC Investment Options [Member] |
|
Investment, measurement input |
4.70
|
Measurement Input, Risk Free Interest Rate [Member] | RD Offering Investment Options [Member] |
|
Investment, measurement input |
4.70
|
Measurement Input, Risk Free Interest Rate [Member] | PIPE Offering Investment Options [Member] |
|
Investment, measurement input |
4.70
|
Measurement Input Expected Market Rate [Member] | HC Wainwright and Co LLC Investment Options [Member] |
|
Investment, measurement input |
|
January 2021 Warrants [Member] |
|
Warrants term |
2 years 3 months 18 days
|
Warrants, number of warrants | shares |
36,429
|
Value (per share) |
|
January 2021 Warrants [Member] | Measurement Input, Share Price [Member] |
|
Warrant measurement input |
2.38
|
January 2021 Warrants [Member] | Measurement Input, Exercise Price [Member] |
|
Warrant measurement input |
$ 247.50
|
January 2021 Warrants [Member] | Measurement Input, Expected Dividend Rate [Member] |
|
Warrants, measurement input |
|
January 2021 Warrants [Member] | Measurement Input, Option Volatility [Member] |
|
Warrants, measurement input |
80.0
|
January 2021 Warrants [Member] | Measurement Input, Risk Free Interest Rate [Member] |
|
Warrants, measurement input |
5.00
|
February 2021 Warrants [Member] |
|
Warrants term |
2 years 4 months 24 days
|
Warrants, number of warrants | shares |
34,281
|
Value (per share) |
|
February 2021 Warrants [Member] | Measurement Input, Share Price [Member] |
|
Warrant measurement input |
2.38
|
February 2021 Warrants [Member] | Measurement Input, Exercise Price [Member] |
|
Warrant measurement input |
$ 245.00
|
February 2021 Warrants [Member] | Measurement Input, Expected Dividend Rate [Member] |
|
Warrants, measurement input |
|
February 2021 Warrants [Member] | Measurement Input, Option Volatility [Member] |
|
Warrants, measurement input |
85.0
|
February 2021 Warrants [Member] | Measurement Input, Risk Free Interest Rate [Member] |
|
Warrants, measurement input |
4.90
|
February 2022 Warrants [Member] |
|
Warrants term |
3 years 4 months 24 days
|
Warrants, number of warrants | shares |
338,000
|
Value (per share) |
$ 0.46
|
February 2022 Warrants [Member] | Measurement Input, Share Price [Member] |
|
Warrant measurement input |
2.38
|
February 2022 Warrants [Member] | Measurement Input, Exercise Price [Member] |
|
Warrant measurement input |
$ 27.50
|
February 2022 Warrants [Member] | Measurement Input, Expected Dividend Rate [Member] |
|
Warrants, measurement input |
|
February 2022 Warrants [Member] | Measurement Input, Option Volatility [Member] |
|
Warrants, measurement input |
96.0
|
February 2022 Warrants [Member] | Measurement Input, Risk Free Interest Rate [Member] |
|
Warrants, measurement input |
4.80
|
February 2022 Post Modification Warrants [Member] |
|
Warrants term |
4 years 3 months 18 days
|
Warrants, number of warrants | shares |
122,000
|
Value (per share) |
$ 1.18
|
February 2022 Post Modification Warrants [Member] | Measurement Input, Share Price [Member] |
|
Warrant measurement input |
2.38
|
February 2022 Post Modification Warrants [Member] | Measurement Input, Exercise Price [Member] |
|
Warrant measurement input |
$ 7.78
|
February 2022 Post Modification Warrants [Member] | Measurement Input, Expected Dividend Rate [Member] |
|
Warrants, measurement input |
|
February 2022 Post Modification Warrants [Member] | Measurement Input, Option Volatility [Member] |
|
Warrants, measurement input |
94.0
|
February 2022 Post Modification Warrants [Member] | Measurement Input, Risk Free Interest Rate [Member] |
|
Warrants, measurement input |
4.70
|
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v3.23.3
SCHEDULE OF PREPAID EXPENSES AND OTHER CURRENT ASSETS (Details) - USD ($)
|
Sep. 30, 2023 |
Dec. 31, 2022 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] |
|
|
Prepaid research and development |
$ 651,623
|
$ 268,686
|
Prepaid value-added taxes |
229,909
|
159,782
|
Prepaid professional fees |
74,500
|
|
Prepaid insurance |
332,508
|
174,406
|
Prepaid other |
146,014
|
105,179
|
Deferred offering costs |
125,800
|
|
Total prepaid expenses and other current assets |
$ 1,560,354
|
$ 708,053
|
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v3.23.3
SCHEDULE OF FINITE LIVED INTANGIBLE ASSETS (Details) - USD ($)
|
3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Goodwill and Intangible Assets Disclosure [Abstract] |
|
|
|
|
Balance, Definite lived intangible assets |
|
|
$ 379,686
|
|
Amortization |
$ (42,191)
|
$ (42,191)
|
(126,566)
|
$ (126,563)
|
Balance, Definite lived intangible assets |
$ 253,120
|
|
$ 253,120
|
|
X |
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INTANGIBLE ASSETS (Details Narrative) - USD ($)
|
3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Goodwill and Intangible Assets Disclosure [Abstract] |
|
|
|
|
Identified definite lived assets, impairment loss |
$ 0
|
$ 0
|
$ 0
|
$ 0
|
Intangible assets, amortization expense |
$ 42,191
|
$ 42,191
|
$ 126,566
|
$ 126,563
|
X |
- DefinitionThe aggregate expense charged against earnings to allocate the cost of intangible assets (nonphysical assets not used in production) in a systematic and rational manner to the periods expected to benefit from such assets. As a noncash expense, this element is added back to net income when calculating cash provided by or used in operations using the indirect method.
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v3.23.3
SCHEDULE OF PROPERTY PLANT AND EQUIPMENT NET OF ACCUMULATED DEPRECIATION (Details) - USD ($)
|
Sep. 30, 2023 |
Dec. 31, 2022 |
Property, Plant and Equipment [Line Items] |
|
|
Less: Accumulated depreciation |
$ (307,067)
|
$ (178,775)
|
Property and equipment, net of accumulated depreciation |
539,152
|
677,485
|
Lab Equipment [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Computer equipment and leasehold improvements |
818,460
|
831,123
|
Computer Equipment and Leasehold Improvements [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Computer equipment and leasehold improvements |
$ 27,759
|
$ 25,137
|
X |
- DefinitionAmount of accumulated depreciation, depletion and amortization for physical assets used in the normal conduct of business to produce goods and services.
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v3.23.3
SCHEDULE OF ACCRUED LIABILITIES (Details) - USD ($)
|
Sep. 30, 2023 |
Dec. 31, 2022 |
Payables and Accruals [Abstract] |
|
|
Product development |
$ 94,663
|
$ 195,104
|
Accrued salaries and wages |
729,616
|
1,175,963
|
Professional fees |
74,499
|
83,255
|
Accrued restructuring costs |
607,602
|
|
Accrued franchise taxes |
9,449
|
|
Patent costs |
18,000
|
251,333
|
Total accrued expenses |
$ 1,533,829
|
$ 1,705,655
|
X |
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v3.23.3
SCHEDULE OF STOCK OPTION (Details)
|
9 Months Ended |
Sep. 30, 2023
USD ($)
$ / shares
shares
|
Equity [Abstract] |
|
Number of Shares, Outstanding at beginning | shares |
48,329
|
Weighted Average Exercise Price, Outstanding at beginning |
$ 37.05
|
Weighted Average Grant Date Fair Value, Outstanding at beginning |
$ 44.82
|
Weighted Average Remaining Contractual Term (years) |
4 years 1 month 6 days
|
Aggregate Intrinsic Value, Outstanding at beginning | $ |
|
Number of Shares, Forfeited | shares |
(16,476)
|
Weighted Average Exercise Price, Forfeited |
$ 5.79
|
Weighted Average Grant Date Fair Value, Forfeited |
$ 5.80
|
Number of Shares, Outstanding at end | shares |
31,852
|
Weighted Average Exercise Price, Outstanding at end |
$ 53.18
|
Weighted Average Grant Date Fair Value, Outstanding at end |
$ 74.04
|
Weighted Average Remaining Contractual Term (years), Outstanding |
3 years 4 months 24 days
|
Aggregate Intrinsic Value, Outstanding at end | $ |
|
Number of Shares, Exercisable | shares |
24,626
|
Weighted Average Exercise Price, Exercisable |
$ 63.72
|
Weighted Average Grant Date Fair Value, Exercisable |
$ 86.52
|
Weighted Average Remaining Contractual Term (years), Exercisable |
3 years
|
Aggregate Intrinsic Value, Exercisable | $ |
|
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v3.23.3
SCHEDULE OF RESTRICTED STOCK UNITS AND AWARDS ACTIVITY (Details) - Restricted Stock Units (RSUs) [Member]
|
9 Months Ended |
Sep. 30, 2023
$ / shares
shares
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Number of shares, non-vested beginning | shares |
64,053
|
Weighted average fair value, non-vested beginning | $ / shares |
$ 92.57
|
Number of shares, granted | shares |
182,500
|
Weighted average fair value, granted | $ / shares |
$ 2.73
|
Number of shares, vested | shares |
(62,636)
|
Weighted average fair value, vested | $ / shares |
$ 19.80
|
Number of shares, forfeited | shares |
(35,666)
|
Weighted average fair value, forfeited | $ / shares |
$ 27.45
|
Number of shares, non-vested ending | shares |
148,251
|
Weighted average fair value, non-vested ending | $ / shares |
$ 28.39
|
X |
- DefinitionThe number of equity-based payment instruments, excluding stock (or unit) options, that were forfeited during the reporting period.
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SCHEDULE OF STOCK-BASED COMPENSATION FOR RESTRICTED STOCK UNITS (Details) - USD ($)
|
3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Total |
$ 328,253
|
$ 590,190
|
$ 1,638,365
|
$ 1,932,553
|
General and Administrative Expense [Member] |
|
|
|
|
Total |
101,607
|
357,756
|
946,851
|
1,138,080
|
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|
|
|
|
Total |
$ 226,646
|
$ 232,434
|
$ 691,514
|
$ 794,473
|
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SCHEDULE OF WARRANTS OUTSTANDING (Details) - Warrant [Member] - USD ($)
|
9 Months Ended |
12 Months Ended |
Sep. 30, 2023 |
Dec. 31, 2022 |
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
Warrant shares outstanding,exchanged for common stock |
655,463
|
|
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$ 58.36
|
|
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2 years 10 months 24 days
|
3 years 7 months 6 days
|
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$ 5,514
|
|
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(45,570)
|
|
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$ 111.50
|
|
Warrant shares outstanding,exchanged for common stock |
609,893
|
|
Weighted average exercise price, issued |
$ 50.46
|
|
Intrinsic value, ending |
|
$ 5,514
|
Warrant shares outstanding,exchanged for common stock |
609,893
|
|
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$ 50.46
|
|
Weighted average remaining life, exercisable |
2 years 10 months 24 days
|
|
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|
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v3.23.3
SCHEDULE OF WARRANTS AND INVESTMENT OPTIONS (Details) - Investment Options [Member] - $ / shares
|
9 Months Ended |
12 Months Ended |
Sep. 30, 2023 |
Dec. 31, 2022 |
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
Investment options outstanding, issued |
1,070,000
|
|
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$ 7.93
|
|
Weighted average remaining life, outstanding ended |
4 years 3 months 18 days
|
5 years 1 month 6 days
|
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1,070,000
|
|
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$ 7.93
|
|
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1,070,000
|
|
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$ 7.93
|
|
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4 years 3 months 18 days
|
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v3.23.3
SHARE CAPITAL AND OTHER EQUITY INSTRUMENTS (Details Narrative) - USD ($)
|
|
|
|
|
|
3 Months Ended |
9 Months Ended |
|
Sep. 01, 2023 |
Jul. 26, 2022 |
Jul. 22, 2022 |
May 03, 2022 |
Feb. 15, 2022 |
Sep. 30, 2023 |
Jun. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Dec. 31, 2022 |
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Common stock voting rights |
|
|
|
|
|
|
|
|
The
holders of the Company’s common stock are entitled to one vote per share
|
|
|
Common stock, shares authorized |
|
|
|
|
|
100,000,000
|
|
|
100,000,000
|
|
100,000,000
|
Preferred stock, shares authorized |
|
|
|
|
|
20,000,000
|
|
|
20,000,000
|
|
20,000,000
|
Common stock, par value |
|
|
|
|
|
$ 0.01
|
|
|
$ 0.01
|
|
$ 0.01
|
Offering expenses |
|
|
|
|
|
$ 125,800
|
|
|
$ 125,800
|
|
|
Offerings costs |
|
|
|
|
|
|
|
|
105,000
|
|
|
Incentive plan description |
|
|
|
(i) increase the aggregate number of shares available
for the grant of awards by 146,083 shares to a total of 200,000 shares, and (ii) add an “evergreen” provision whereby the
number of shares authorized for issuance pursuant to awards under the Incentive Plan will be automatically increased on the first trading
date immediately following the date the Company issues any share of Common Stock (defined below) to any person or entity, to the extent
necessary so that the number of shares of the Company’s Common Stock authorized for issuance under the Incentive Plan will equal
the greater of (x) 200,000 shares, and (y) 15% of the total number of shares of the Company’s Common Stock outstanding as of such
issuance date. The Plan Amendment was approved by the Company’s shareholders at a special meeting of the Company’s shareholders
held on July 14, 2022
|
|
|
|
|
|
|
|
Stock based compensation, expenses |
|
|
|
|
|
328,253
|
|
$ 590,190
|
1,638,365
|
1,932,553
|
|
Share-Based Payment Arrangement, Option [Member] |
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Stock based compensation, expenses |
|
|
|
|
|
44,606
|
|
48,697
|
147,067
|
134,383
|
|
Stock-based compensation, unamortized |
|
|
|
|
|
93,697
|
|
|
$ 93,697
|
|
|
Weighted average period |
|
|
|
|
|
|
|
|
1 year
|
|
|
Restricted Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Stock based compensation, expenses |
|
|
|
|
|
$ 0
|
|
6,250
|
$ 0
|
24,363
|
|
Common stock vested restricted stock units |
|
|
|
|
|
708
|
|
|
|
|
|
Unissued shares for cash |
|
|
|
|
|
$ 14,250
|
|
|
|
|
|
Number of vested and unissued shares |
|
|
|
|
|
0
|
|
|
0
|
|
|
Restricted Stock Units (RSUs) [Member] |
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Stock based compensation, expenses |
|
|
|
|
|
$ 328,253
|
|
$ 590,190
|
$ 1,638,365
|
$ 1,932,553
|
|
Stock-based compensation, unamortized |
|
|
|
|
|
$ 2,388,221
|
|
|
$ 2,388,221
|
|
|
Weighted average period |
|
|
|
|
|
|
|
|
2 years 3 months 18 days
|
|
|
Common stock vested restricted stock units |
|
|
|
|
|
|
|
|
62,636
|
|
|
Common Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Issuance of common shares in exchange for RSU conversions from the reduction in force, shares |
|
|
|
|
|
40,130
|
63,511
|
|
103,641
|
2,122
|
|
Common Stock [Member] | Restricted Stock Units (RSUs) [Member] |
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Common stock vested restricted stock units |
|
|
|
|
|
|
|
|
20,847
|
|
|
RD Offering and Pipe Investment Options [Member] |
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Proceeds from RD offerings |
|
$ 8,000,000
|
|
|
|
|
|
|
|
|
|
Offerings costs |
|
7,100,000
|
|
|
|
|
|
|
|
|
|
Payments of allocated equity |
|
3,200,000
|
|
|
|
|
|
|
|
|
|
Payments of investment option liability |
|
4,300,000
|
|
|
|
|
|
|
|
|
|
Payments of stock issuance costs recorded expense |
|
$ 400,000
|
|
|
|
|
|
|
|
|
|
Underwriters [Member] |
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Offering expenses |
|
|
|
|
$ 5,800,000
|
|
|
|
|
|
|
Issued shares |
|
|
|
|
60,000
|
|
|
|
|
|
|
Purchase of common stock |
|
|
|
|
60,000
|
|
|
|
|
|
|
Exercised of warrants |
|
|
|
|
60,000
|
|
|
|
|
|
|
Net proceeds from offering |
|
|
|
|
$ 9,100,000
|
|
|
|
|
|
|
Warrant liability |
|
|
|
|
3,600,000
|
|
|
|
|
|
|
Proceeds from issuance of warrants |
|
|
|
|
$ 300,000
|
|
|
|
|
|
|
IPO [Member] |
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Issued shares |
|
|
|
|
400,000
|
|
|
|
|
|
|
Purchase of common stock |
|
|
|
|
400,000
|
|
|
|
|
|
|
Proceeds from common stock |
|
|
|
|
$ 10,000,000.0
|
|
|
|
|
|
|
Distribution Agreement [Member] | Canaccord Genuity LLC [Member] |
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Common stock, par value |
$ 0.01
|
|
|
|
|
|
|
|
|
|
|
Common stock, offering price |
$ 10,000,000.0
|
|
|
|
|
|
|
|
|
|
|
Aggregate gross sales price |
$ 2,392,514
|
|
|
|
|
|
|
|
|
|
|
Commission percentage |
3.00%
|
|
|
|
|
|
|
|
|
|
|
Offering expenses |
|
|
|
|
|
$ 125,800
|
|
|
$ 125,800
|
|
|
Registered Direct Securities Purchase Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Issued shares |
|
|
375,000
|
|
|
|
|
|
|
|
|
Purchase of common stock |
|
|
258,500
|
|
|
|
|
|
|
|
|
Proceeds from issuance of warrants |
|
|
$ 3,000,000
|
|
|
|
|
|
|
|
|
Sale of stock |
|
|
116,500
|
|
|
|
|
|
|
|
|
Share price |
|
|
$ 0.0001
|
|
|
|
|
|
|
|
|
PIPE Securities Purchase Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Issued shares |
|
|
625,000
|
|
|
|
|
|
|
|
|
Purchase of common stock |
|
|
509,000
|
|
|
|
|
|
|
|
|
Proceeds from issuance of warrants |
|
|
$ 5,000,000
|
|
|
|
|
|
|
|
|
Sale of stock |
|
|
116,000
|
|
|
|
|
|
|
|
|
Share price |
|
|
$ 0.0001
|
|
|
|
|
|
|
|
|
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v3.23.3
REDEEMABLE NON-CONTROLLING INTEREST (Details Narrative) - USD ($)
|
|
|
1 Months Ended |
9 Months Ended |
|
|
May 12, 2023 |
May 05, 2022 |
May 31, 2023 |
Sep. 30, 2023 |
Jun. 30, 2023 |
Dec. 31, 2022 |
Common stock par value |
|
|
|
$ 0.01
|
|
$ 0.01
|
Dividends |
$ 1,052,057
|
|
|
|
|
|
Derivative liabilities |
|
|
|
|
$ 714,000
|
|
Redeemable non-controlling interest |
|
|
|
|
|
$ 885,028
|
Series A Preferred Stock [Member] |
|
|
|
|
|
|
Dividends, per share |
$ 1,000
|
|
$ 1,000
|
|
|
|
Unpaid dividends |
$ 52,057
|
|
$ 52,000
|
|
|
|
Dividends |
|
|
1,052,000
|
|
|
|
Redeemable noncontrolling interest |
|
|
$ 1,052,057
|
|
|
|
Akos Securities Purchase Agreement [Member] |
|
|
|
|
|
|
Common stock par value |
|
$ 0.01
|
|
|
|
|
Sale of stock, value |
|
$ 4,000,000
|
|
|
|
|
Spin-off and related private placement, description |
|
Pursuant to the Akos Purchase Agreement, Akos had agreed to pay Palladium a
fee equal to 9% of the aggregate gross proceeds raised from the sale of the shares of the Akos Series A Preferred Stock and a non-accountable
expense allowance of 1% of the aggregate gross proceeds raised the sale of the Akos Series A Preferred Stock in the Akos Private Placement.
The fee due in connection with the Akos Private Placement to be paid to Palladium in the form of convertible preferred stock and warrants
was on similar terms to the securities issued in the Akos Private Placement.
|
|
|
|
|
Warrants to purchase common stock, percentage |
|
|
|
8.00%
|
|
|
Akos Securities Purchase Agreement [Member] | Maximum [Member] |
|
|
|
|
|
|
Sale of stock, value |
|
$ 5,000,000
|
|
|
|
|
Akos Securities Purchase Agreement [Member] | Series A Convertible Preferred Stock [Member] |
|
|
|
|
|
|
Sale of stock |
|
5,000
|
|
|
|
|
Sale of stock, price per share |
|
$ 1,000
|
|
|
|
|
Akos Securities Purchase Agreement [Member] | Series A Preferred Stock [Member] |
|
|
|
|
|
|
Sale of stock |
|
1,000
|
|
|
|
|
Sale of stock, value |
|
$ 1,000,000
|
|
|
|
|
Securities purchase agreement [Member] |
|
|
|
|
|
|
Sale of stock, price per share |
|
$ 1,000
|
|
|
|
|
Securities purchase agreement [Member] | Series A Preferred Stock [Member] | Akos [Member] |
|
|
|
|
|
|
Percentage of stock issued and outstanding |
|
25.00%
|
|
|
|
|
Dividend rate |
|
5.00%
|
|
|
|
|
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v3.23.3
COMMITMENTS AND CONTINGENCIES (Details Narrative)
|
|
3 Months Ended |
9 Months Ended |
|
|
Dec. 26, 2017
USD ($)
|
Sep. 30, 2023
USD ($)
|
Sep. 30, 2022
USD ($)
|
Sep. 30, 2023
USD ($)
|
Sep. 30, 2022
USD ($)
|
Mar. 23, 2023
USD ($)
|
Mar. 23, 2023
AUD ($)
|
Dec. 31, 2022
USD ($)
|
Property, Plant and Equipment [Line Items] |
|
|
|
|
|
|
|
|
Prepaid assets |
|
$ 1,560,354
|
|
$ 1,560,354
|
|
|
|
$ 708,053
|
research and development expenses |
|
1,351,750
|
$ 2,055,656
|
5,883,440
|
$ 6,134,421
|
|
|
|
Future cash |
|
4,266,568
|
|
4,266,568
|
|
|
|
$ 17,723,884
|
Vogal Nathan Purchase Agreement [Member] | One Time Milestone [Member] |
|
|
|
|
|
|
|
|
Property, Plant and Equipment [Line Items] |
|
|
|
|
|
|
|
|
Long-term purchase commitment, amount |
$ 200,000
|
|
|
|
|
|
|
|
Vogal Nathan Purchase Agreement [Member] | Additional Milestone [Member] |
|
|
|
|
|
|
|
|
Property, Plant and Equipment [Line Items] |
|
|
|
|
|
|
|
|
Long-term purchase commitment, amount |
$ 300,000
|
|
|
|
|
|
|
|
Other Consulting and Vendor Agreements [Member] |
|
|
|
|
|
|
|
|
Property, Plant and Equipment [Line Items] |
|
|
|
|
|
|
|
|
Future cash |
|
1,200,000
|
|
1,200,000
|
|
|
|
|
Avance Clinical [Member] |
|
|
|
|
|
|
|
|
Property, Plant and Equipment [Line Items] |
|
|
|
|
|
|
|
|
Contract cost |
|
950,997
|
|
950,997
|
|
$ 2,000,000
|
$ 3,000,000
|
|
Prepaid assets |
|
549,713
|
|
549,713
|
|
|
|
|
research and development expenses |
|
$ 157,117
|
|
$ 401,284
|
|
|
|
|
X |
- DefinitionAmount, after accumulated amortization and accumulated impairment loss, of asset recognized from cost incurred to obtain or fulfill contract with customer.
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- DefinitionFace amount or stated value per share of common stock.
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Enveric Biosciences (NASDAQ:ENVB)
過去 株価チャート
から 8 2024 まで 9 2024
Enveric Biosciences (NASDAQ:ENVB)
過去 株価チャート
から 9 2023 まで 9 2024