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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: June 30, 2024
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 (§ 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. ☐
If
securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant
included in the filing reflect the correction of an error to previously issued financial statements. ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
As
of August 9, 2024, there were 8,919,920 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
| |
June
30, 2024 | | |
December
31, 2023 | |
| |
(unaudited) | | |
| |
ASSETS | |
| | | |
| | |
Current
assets: | |
| | | |
| | |
Cash | |
$ | 3,502,551 | | |
$ | 2,287,977 | |
Prepaid expenses and other current assets | |
| 2,017,383 | | |
| 1,293,554 | |
Total current assets | |
| 5,519,934 | | |
| 3,581,531 | |
| |
| | | |
| | |
Other
assets: | |
| | | |
| | |
Property and equipment, net | |
| 405,114 | | |
| 507,377 | |
Intangible assets, net | |
| 126,556 | | |
| 210,932 | |
Total other assets | |
| 531,670 | | |
| 718,309 | |
Total assets | |
$ | 6,051,604 | | |
$ | 4,299,840 | |
| |
| | | |
| | |
LIABILITIES, MEZZANINE EQUITY,
AND SHAREHOLDERS’ EQUITY | |
| | | |
| | |
Current
liabilities: | |
| | | |
| | |
Accounts payable | |
$ | 459,898 | | |
$ | 1,218,783 | |
Accrued liabilities | |
| 176,373 | | |
| 1,075,643 | |
Investment option liability | |
| 4,443 | | |
| 23,608 | |
Warrant liability | |
| 4,626 | | |
| 25,470 | |
Total current liabilities | |
| 645,340 | | |
| 2,343,504 | |
| |
| | | |
| | |
Commitments and contingencies
(Note 8) | |
| - | | |
| - | |
| |
| | | |
| | |
Mezzanine equity | |
| | | |
| | |
Series C redeemable
preferred stock, $0.01 par value, 100,000 shares authorized, and 0 shares issued and outstanding as of June 30, 2024 and December
31, 2023 | |
| — | | |
| — | |
Total
mezzanine equity | |
| — | | |
| — | |
| |
| | | |
| | |
Shareholders’ equity | |
| | | |
| | |
Preferred stock, $0.01 par value, 20,000,000
shares authorized; Series B preferred stock, $0.01 par value, 3,600,000 shares authorized, 0 shares issued and outstanding as of
June 30, 2024 and December 31, 2023 | |
| — | | |
| — | |
Common stock, $0.01 par value, 100,000,000
shares authorized, 7,878,568 and 2,739,315 shares issued and outstanding as of June 30, 2024 and December 31, 2023 | |
| 78,785 | | |
| 27,392 | |
Additional paid-in capital | |
| 106,729,801 | | |
| 100,815,851 | |
Stock subscription receivable | |
| — | | |
| (1,817,640 | ) |
Accumulated deficit | |
| (100,835,827 | ) | |
| (96,499,518 | ) |
Accumulated other comprehensive loss | |
| (566,495 | ) | |
| (569,749 | ) |
Total
shareholders’ equity | |
| 5,406,264 | | |
| 1,956,336 | |
Total
liabilities, mezzanine equity, and shareholders’ equity | |
$ | 6,051,604 | | |
$ | 4,299,840 | |
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
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
For
the Three Months Ended June 30, | | |
For
the Six Months Ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Operating expenses | |
| | | |
| | | |
| | | |
| | |
General and
administrative | |
$ | 1,297,651 | | |
$ | 3,272,900 | | |
$ | 3,231,404 | | |
$ | 6,192,700 | |
Research and development | |
| 515,501 | | |
| 2,395,589 | | |
| 973,656 | | |
| 4,249,981 | |
Depreciation and amortization | |
| 84,779 | | |
| 86,518 | | |
| 170,188 | | |
| 173,004 | |
Total
operating expenses | |
| 1,897,931 | | |
| 5,755,007 | | |
| 4,375,248 | | |
| 10,615,685 | |
| |
| | | |
| | | |
| | | |
| | |
Loss from operations | |
| (1,897,931 | ) | |
| (5,755,007 | ) | |
| (4,375,248 | ) | |
| (10,615,685 | ) |
| |
| | | |
| | | |
| | | |
| | |
Other income (expense) | |
| | | |
| | | |
| | | |
| | |
Change in fair value of
warrant liabilities | |
| 10,805 | | |
| (233,821 | ) | |
| 20,844 | | |
| (183,164 | ) |
Change in fair value of
investment option liability | |
| 7,767 | | |
| (1,082,141 | ) | |
| 19,165 | | |
| (962,636 | ) |
Change in fair value of
derivative liability | |
| — | | |
| 714,000 | | |
| — | | |
| 727,000 | |
Interest income (expense),
net | |
| (35 | ) | |
| 916 | | |
| 661 | | |
| 905 | |
Total
other income (expense) | |
| 18,537 | | |
| (601,046 | ) | |
| 40,670 | | |
| (417,895 | ) |
| |
| | | |
| | | |
| | | |
| | |
| |
| | | |
| | | |
| | | |
| | |
Income tax expense | |
| — | | |
| — | | |
| (1,731 | ) | |
| — | |
| |
| | | |
| | | |
| | | |
| | |
Net loss | |
| (1,879,394 | ) | |
| (6,356,053 | ) | |
| (4,336,309 | ) | |
| (11,033,580 | ) |
Less preferred dividends
attributable to non-controlling interest | |
| — | | |
| 6,712 | | |
| — | | |
| 19,041 | |
Less deemed dividends attributable
to accretion of embedded derivative at redemption value | |
| — | | |
| 36,997 | | |
| — | | |
| 147,988 | |
Net loss attributable to
shareholders | |
| (1,879,394 | ) | |
| (6,399,762 | ) | |
| (4,336,309 | ) | |
| (11,200,609 | ) |
| |
| | | |
| | | |
| | | |
| | |
Other comprehensive loss | |
| | | |
| | | |
| | | |
| | |
Foreign currency translation | |
| (14,652 | ) | |
| (11,286 | ) | |
| 3,254 | | |
| (9,318 | ) |
| |
| | | |
| | | |
| | | |
| | |
Comprehensive
loss | |
$ | (1,894,046 | ) | |
$ | (6,411,048 | ) | |
$ | (4,333,055 | ) | |
$ | (11,209,927 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net loss per share -
basic and diluted | |
$ | (0.25 | ) | |
$ | (3.04 | ) | |
$ | (0.75 | ) | |
$ | (5.35 | ) |
| |
| | | |
| | | |
| | | |
| | |
Weighted average shares outstanding, basic
and diluted | |
| 7,587,851 | | |
| 2,107,583 | | |
| 5,794,653 | | |
| 2,093,008 | |
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 SIX MONTHS ENDED JUNE 30, 2024 AND 2023
| |
- |
Shares | | |
Amount | | |
Capital | | |
Receivable | | |
Deficit | | |
Loss | | |
Equity | |
| |
Common
Stock | | |
Additional
Paid-In | | |
Subscription | | |
Accumulated | | |
Accumulated Other Comprehensive | | |
Total Shareholders’ | |
| |
Shares | | |
Amount | | |
Capital | | |
Receivable | | |
Deficit | | |
Loss | | |
Equity | |
Balance at January 1, 2024 | - |
- | 2,739,315 | | |
| 27,392 | | |
| 100,815,851 | | |
| (1,817,640 | ) | |
| (96,499,518 | ) | |
| (569,749 | ) | |
| 1,956,336 | |
Stock-based compensation | - |
- | — | | |
| — | | |
| 351,488 | | |
| — | | |
| — | | |
| — | | |
| 351,488 | |
Common stock sold under
the Equity Distribution Agreement, net of offering costs of $583,713 | |
| 1,668,000 | | |
| 16,680 | | |
| 1,792,109 | | |
| — | | |
| — | | |
| — | | |
| 1,808,789 | |
Issuance of direct offering
shares (see Note 7) | |
| 228,690 | | |
| 2,287 | | |
| 320,166 | | |
| — | | |
| — | | |
| — | | |
| 322,453 | |
Exercise of Inducement
Warrants for common stock | |
| 1,954,000 | | |
| 19,540 | | |
| 2,657,440 | | |
| — | | |
| — | | |
| — | | |
| 2,676,980 | |
Proceeds from the subscription
receivable related to the issuance of Inducement Warrants, net of offering costs of $12,821 | |
| — | | |
| — | | |
| (12,821 | ) | |
| 280,500 | | |
| — | | |
| — | | |
| 267,679 | |
Proceeds from the subscription
receivable related to the exercise of warrants and preferred investment options and issuance of common stock in abeyance | |
| 704,000 | | |
| 7,040 | | |
| (7,040 | ) | |
| 1,537,140 | | |
| — | | |
| — | | |
| 1,537,140 | |
Foreign exchange translation
gain | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| 17,906 | | |
| 17,906 | |
Net loss | - |
- | — | | |
| — | | |
| — | | |
| — | | |
| (2,456,915 | ) | |
| — | | |
| (2,456,915 | ) |
Balance at March 31,
2024 | - |
- | 7,294,005 | | |
$ | 72,939 | | |
$ | 105,917,193 | | |
$ | — | | |
$ | (98,956,433 | ) | |
$ | (551,843 | ) | |
$ | 6,481,856 | |
Stock-based compensation | - |
- | — | | |
| — | | |
| 369,614 | | |
| — | | |
| — | | |
| — | | |
| 369,614 | |
Common stock sold under
the Purchase Agreement, net of offering costs of $82,850 | |
| 125,000 | | |
| 1,250 | | |
| (1,250 | ) | |
| — | | |
| — | | |
| — | | |
| — | |
Issuance of direct offering
shares (see Note 7) | |
| 458,000 | | |
| 4,580 | | |
| 444,260 | | |
| — | | |
| — | | |
| — | | |
| 448,840 | |
Issuance of common shares
for vested RSU | |
| 1,563 | | |
| 16 | | |
| (16 | ) | |
| — | | |
| — | | |
| — | | |
| — | |
Foreign exchange translation
loss | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| (14,652 | ) | |
| (14,652 | ) |
Net loss | - |
- | — | | |
| — | | |
| — | | |
| — | | |
| (1,879,394 | ) | |
| — | | |
| (1,879,394 | ) |
Balance at June 30,
2024 | - |
- | 7,878,568 | | |
$ | 78,785 | | |
$ | 106,729,801 | | |
$ | — | | |
$ | (100,835,827 | ) | |
$ | (566,495 | ) | |
$ | 5,406,264 | |
| |
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 | |
Balance value | |
| 1,000 | | |
$ | 1,008,348 | | |
$ | 1,008,348 | | |
| 2,078,271 | | |
$ | 20,782 | | |
$ | 94,805,177 | | |
$ | (83,885,313 | ) | |
$ | (534,766 | ) | |
$ | 10,405,880 | |
Stock-based compensation | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| 879,738 | | |
| — | | |
| — | | |
| 879,738 | |
Preferred dividends attributable
to redeemable | |
| — | | |
| 6,712 | | |
| 6,712 | | |
| — | | |
| — | | |
| (6,712 | ) | |
| — | | |
| — | | |
| (6,712 | ) |
Accretion of embedded derivative
to redemption value | |
| — | | |
| 36,997 | | |
| 36,997 | | |
| — | | |
| — | | |
| (36,997 | ) | |
| — | | |
| — | | |
| (36,997 | ) |
Redemption of Series A
preferred stock | |
| (1,000 | ) | |
| (1,052,057 | ) | |
| (1,052,057 | ) | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | |
Issuance of common shares
in exchange for RSU conversions from the reduction in force | |
| — | | |
| — | | |
| — | | |
| 63,511 | | |
| 635 | | |
| (635 | ) | |
| — | | |
| — | | |
| — | |
Foreign exchange translation
loss | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| (11,286 | ) | |
| (11,286 | ) |
Net loss | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| (6,356,053 | ) | |
| — | | |
| (6,356,053 | ) |
Balance at June 30,
2023 | |
| — | | |
$ | — | | |
$ | — | | |
| 2,141,782 | | |
$ | 21,417 | | |
$ | 95,640,571 | | |
$ | (90,241,366 | ) | |
$ | (546,052 | ) | |
$ | 4,874,570 | |
Balance value | |
| — | | |
$ | — | | |
$ | — | | |
| 2,141,782 | | |
$ | 21,417 | | |
$ | 95,640,571 | | |
$ | (90,241,366 | ) | |
$ | (546,052 | ) | |
$ | 4,874,570 | |
See
the accompanying notes to the unaudited condensed consolidated financial statements.
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
UNAUDITED
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
| |
2024 | | |
2023 | |
| |
For the Six
Months Ended June 30, | |
| |
2024 | | |
2023 | |
Cash Flows From Operating
Activities: | |
| | | |
| | |
Net loss | |
$ | (4,336,309 | ) | |
$ | (11,033,580 | ) |
Adjustments to reconcile
net loss to cash used in operating activities | |
| | | |
| | |
Change in fair value of
warrant liability | |
| (20,844 | ) | |
| 183,164 | |
Change in fair value of
investment option liability | |
| (19,165 | ) | |
| 962,636 | |
Change in fair value of
derivative liability | |
| — | | |
| (727,000 | ) |
Stock-based compensation | |
| 721,102 | | |
| 1,412,573 | |
Amortization of right of
use asset | |
| — | | |
| 54,703 | |
Amortization of intangibles | |
| 84,376 | | |
| 84,375 | |
Depreciation expense | |
| 85,812 | | |
| 88,629 | |
Gain on disposal of property
and equipment | |
| — | | |
| (4,212 | ) |
Change
in operating assets and liabilities: | |
| | | |
| | |
Prepaid expenses and other
current assets | |
| (543,822 | ) | |
| (1,111,913 | ) |
Accounts payable and accrued
liabilities | |
| (1,458,670 | ) | |
| 542,397 | |
Right-of-use operating
lease asset and obligation | |
| — | | |
| (54,702 | ) |
Net cash used in operating
activities | |
| (5,487,520 | ) | |
| (9,602,930 | ) |
| |
| | | |
| | |
Cash Flows From Investing
Activities: | |
| | | |
| | |
Purchases of property and
equipment | |
| — | | |
| (5,187 | ) |
Proceeds from disposal
of property and equipment | |
| — | | |
| 16,872 | |
Net cash provided by investing
activities | |
| — | | |
| 11,685 | |
| |
| | | |
| | |
Cash Flows From Financing
Activities: | |
| | | |
| | |
Proceeds from the subscription
receivable related to the issuance of Inducement Warrants and the exercise of warrants and preferred investment options | |
| 1,804,819 | | |
| — | |
Proceeds from exercise
of Inducement Warrants | |
| 2,676,980 | | |
| — | |
Proceeds from common stock
sold under the Equity Distribution Agreement, net of offering costs | |
| 2,290,186 | | |
| — | |
Proceeds from common stock
sold under the Purchase Agreement, net of offering costs | |
| 82,026 | | |
| — | |
Payment for offering costs
previously accrued | |
| (161,312 | ) | |
| — | |
Redemption of Series A
Preferred Stock | |
| — | | |
| (1,052,057 | ) |
Net cash provided by (used
in) financing activities | |
| 6,692,699 | | |
| (1,052,057 | ) |
| |
| | | |
| | |
Effect of Foreign Exchange
Rate on Changes on Cash | |
| 9,395 | | |
| 826 | |
| |
| | | |
| | |
Net increase (decrease) in cash | |
| 1,214,574 | | |
| (10,642,476 | ) |
Cash at beginning of period | |
| 2,287,977 | | |
| 17,723,884 | |
Cash at end of period | |
$ | 3,502,551 | | |
$ | 7,081,408 | |
| |
| | | |
| | |
Supplemental
disclosure of cash and non-cash transactions: | |
| | | |
| | |
Cash paid for interest | |
$ | — | | |
$ | 11 | |
Income taxes paid | |
$ | 24,001 | | |
$ | — | |
Offering costs accrued
not paid | |
$ | 149 | | |
$ | — | |
Deferred offering costs
charged to offering costs | |
$ | 240,969 | | |
| — | |
Issuance of common shares
for offering costs | |
$ | 771,293 | | |
$ | — | |
Preferred dividends
attributable to redeemable non-controlling interest | |
$ | — | | |
$ | 19,041 | |
Accretion of embedded
derivative to redemption value | |
$ | — | | |
$ | 147,988 | |
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., MagicMed Industries, Inc. (“MagicMed”), Enveric Biosciences Canada, Inc., Akos Biosciences, Inc.
(“Akos”), 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-002 (formerly EB-373) – for the treatment of psychiatric disorders. Enveric is also advancing its product EB-003
from the EVM301 Series, which is 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.
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, N,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™
the Company has three different types of molecules, Generation 1 (classic psychedelics), Generation 2 (new chemical entity pro-drugs
of psilocin), and Generation 3 (new chemical entity analogs). The Company has created over 1000 novel psychedelic molecular compounds
and derivatives that are housed in the Psybrary™. The Company’s current focus is to develop its lead molecules, EB-002 and
EB-003, and to outlicense other molecules from 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.
Going
Concern, Liquidity and Other Uncertainties
The
Company has incurred a loss since inception resulting in an accumulated deficit of $100,835,827 as of June 30, 2024, and further losses
are anticipated in the development of its business. For the six months ended June 30, 2024, the Company has operating cash outflows of
$5,487,520 and had a loss from operations of $4,375,248. Being a research and development company, since inception, 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 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 unaudited condensed consolidated financial statements.
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
In
assessing the Company’s ability to continue as a going concern, the Company monitors and analyzes its cash and its ability to generate
sufficient cash flow in the future to support its operating and capital expenditure commitments. At June 30, 2024, the Company had cash
of $3,502,551 and working capital of $4,874,594. The Company’s current cash on hand is not sufficient to satisfy its operating
cash needs for the 12 months from the filing of this Quarterly Report on Form 10-Q. These conditions raise substantial doubt regarding
the Company’s ability to continue as a going concern for a period of one year after the date the financial statements are issued.
Management’s plan to alleviate the conditions that raise substantial doubt include raising additional working capital through public
or private equity or debt financings or other sources, the Purchase Agreement with Lincoln Park (see Note 7 and 9), subject to registration,
and may include additional collaborations with third parties as well as disciplined cash spending. Adequate additional financing may
not be available to us on acceptable terms, or at all. Should the Company be unable to raise sufficient additional capital, the Company
may be required to undertake cost-cutting measures including delaying or discontinuing certain operating activities.
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 unaudited condensed consolidated 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.
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.
Nasdaq
Notice
On
November 21, 2023, the Company received a letter from the Listing Qualifications Department of the Nasdaq Stock Market (“Nasdaq”)
stating that as of September 30, 2023, the Company did not meet the minimum of $2,500,000 in stockholders’ equity required for
continued listing pursuant to Nasdaq Listing Rule 5550(b)(1). On February 6, 2024, the Company received a letter from Nasdaq, granting
the Company an extension to regain compliance with the minimum stockholders’ equity requirement by May 20, 2024. On May 21, 2024,
the Company received a letter from Nasdaq notifying the Company that it regained compliance with the minimum stockholders’ equity
requirement for continued listing on the Nasdaq.
On
May 16, 2024, the Company received a letter from Nasdaq’s Listing Qualifications Department stating
that because the closing bid price for the Company’s common stock listed on Nasdaq was below $1.00
for 30 consecutive business days, the Company no longer meets the minimum bid price requirement for continued listing on the Nasdaq
Capital Market (the “Minimum Bid Price Requirement”). The Company has a period of 180 calendar days from May 16, 2024,
or until November 12, 2024, to regain compliance with the Minimum Bid Price Requirement. If at any time before November 12, 2024,
the bid price of the Company’s common stock closes at or above $1.00
per share for a minimum of 10 consecutive business days, Nasdaq will provide written notification that the Company has achieved
compliance with the Minimum Bid Price Requirement.
NOTE
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis
of Presentation and Principal of Consolidation
The
accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally
accepted in the United States (“U.S. GAAP”) for interim financial information and Article 8 of Regulation S-X. Accordingly,
they do not include all the information and footnotes required by U.S. GAAP for complete financial statements. Management’s opinion
is that all adjustments (consisting of normal accruals) considered necessary for a fair presentation have been included. Operating results
for the three and six months ended June 30, 2024 are not necessarily indicative of the results that may be expected for the year ending
December 31, 2024. These unaudited condensed consolidated financial statements should be read in conjunction with the consolidated financial
statements for the year ended December 31, 2023, 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 26, 2024.
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
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, 2023. There were no significant changes to these accounting policies during the
three and six months ended June 30, 2024.
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, the
valuation of warrants and preferred investment options, and the valuation of stock-based compensation and accruals associated with
third party providers supporting research and development efforts. Actual results could differ from those estimates.
Reclassification
Certain
reclassifications have been made to the prior period’s unaudited condensed consolidated financial statements in order to conform
to the current year presentation. In the prior year, the Company included certain investor related expenses were included within research
and development on the unaudited condensed consolidated statements of operations. These expenses were reclassified to general and administrative
expenses in the current year. This reclassification had no effect on the Company’s previously reported results of operations, changes
in equity, or cash flows.
Foreign
Currency Translation
From
inception through June 30, 2024, 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 June 30, 2024
and 2023, 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 unaudited condensed consolidated statements of shareholders’ equity as a component of accumulated other comprehensive loss.
The
Company has not entered into any financial derivative instruments that expose it to material market risk, including any instruments designed
to hedge the impact of foreign currency exposures. The Company may, however, hedge such exposure to foreign currency exchange fluctuations
in the future.
Adjustments
that arise from exchange rate changes on transactions denominated in a currency other than the local currency are included in other comprehensive
loss in the unaudited condensed consolidated statements of operations and comprehensive loss as incurred.
Concentration
of Credit Risk
Financial
instruments that potentially subject the Company to concentrations of credit risk consist of cash accounts in a financial institution,
which at times, may exceed the federal depository insurance coverage of $250,000 in the United States and Australia and $100,000 in Canada.
The Company has not experienced losses on these accounts, and management believes the Company is not exposed to significant risks on
such accounts. As of June 30, 2024, the Company had greater than $250,000 at United States financial institutions, less than $250,000
at Australian financial institutions, and less than $100,000 at Canadian financial institutions.
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Research
and Development
Research
and development expenses are charged to operations as incurred. Research and development expenses include, among other things, internal
and external costs associated with preclinical development, pre-commercialization manufacturing expenses, and clinical trials. The Company
accrues for costs incurred as the services are being provided by monitoring the status of the trial or services provided and the invoices
received from its external service providers. In the case of clinical trials, a portion of the estimated cost normally relates to the
projected cost to treat a patient in the trials, and this cost is recognized based on the number of patients enrolled in the trial. As
actual costs become known, the Company adjusts its accruals accordingly.
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.
Research
and Development Tax Incentive Receivable
The
Company, through its wholly-owned subsidiary in Australia, participates in the Australian research and development tax incentive program,
such that a percentage of the Company’s qualifying research and development expenditures are reimbursed by the Australian government,
and such incentives are reflected as a reduction of research and development expense. The Australian research and development tax incentive
is recognized when there is reasonable assurance that the incentive will be received, the relevant expenditure has been incurred and
the amount of the consideration can be reliably measured. At each period end, management estimates the reimbursement available to the
Company based on available information at the time.
Net
Loss per Share
Basic
net loss per share is computed by dividing net loss by the weighted average number of shares of common stock outstanding during the period.
Diluted earnings per share is computed using the weighted average number of common shares and, if dilutive, potential common shares outstanding
during the period. Potential common shares consist of the incremental common shares issuable upon the exercise of stock options and warrants
(using the treasury stock method). The computation of basic net loss per share for the three and six months ended June 30, 2024 and 2023
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 for the three and
six months ended June 30, 2024 and 2023 because the effect of their inclusion would have been anti-dilutive.
SCHEDULE OF POTENTIALLY DILUTIVE SECURITIES
| |
For
the three and six months ended June 30, 2024 | | |
For
the three and six months ended June 30, 2023 | |
Warrants to purchase shares of
common stock | |
| 845,213 | | |
| 655,463 | |
Restricted stock units - vested and unissued | |
| 41,901 | | |
| 55,622 | |
Restricted stock units - unvested | |
| 356,116 | | |
| 180,115 | |
Restricted stock awards - vested and unissued | |
| — | | |
| 708 | |
Investment options to purchase shares of common
stock | |
| 70,000 | | |
| 1,070,000 | |
Options to purchase
shares of common stock | |
| 23,082 | | |
| 36,579 | |
Total potentially dilutive
securities | |
| 1,336,312 | | |
| 1,998,487 | |
Recent
Accounting Pronouncements
In
November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. ASU
2023-07 updates reportable segment disclosure requirements primarily through enhanced disclosures about significant segment expenses.
ASU 2023-07 is effective for all entities for fiscal years beginning after December 15, 2023, and for interim periods within fiscal years
beginning after December 15, 2024. Early adoption is permitted. The amendments should be applied retrospectively to all prior periods
presented in the financial statements. The Company is currently assessing the potential impacts of ASU 2023-07, however as the Company
currently has one reportable segment, does not expect this guidance will not have a material impact on its unaudited
condensed consolidated financial statements.
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
In
December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which amends the
disclosure to address investor requests for more transparency about income tax information through improvements to income tax disclosures
primarily related to the rate reconciliation and income taxes paid information and includes certain other amendments to improve the effectiveness
of income tax disclosures. The ASU is effective on a prospective basis for annual periods beginning after December 15, 2024, and early
adoption and retrospective application are permitted. Early adoption is permitted. The Company is currently assessing potential impacts
of ASU 2023-09 and does not expect the adoption of this guidance will have a material impact on its unaudited condensed consolidated
financial statements and disclosures.
NOTE
3. PREPAID EXPENSES AND OTHER CURRENT ASSETS
As
of June 30, 2024 and December 31, 2023, the prepaid expenses and other current assets of the Company consisted of the following:
SCHEDULE OF PREPAID EXPENSES AND OTHER CURRENT ASSETS
| |
June
30, 2024 | | |
December
31, 2023 | |
Prepaid research and development | |
$ | 257,218 | | |
$ | 46,320 | |
Prepaid value-added taxes | |
| 241,269 | | |
| 243,429 | |
Prepaid insurance | |
| 375,215 | | |
| 149,559 | |
Prepaid other | |
| 81,192 | | |
| 62,036 | |
Deferred offering costs (see Note 7) | |
| 763,173 | | |
| 567,603 | |
Franchise tax receivable | |
| 38,258 | | |
| 79,258 | |
R&D tax incentive
receivable | |
| 261,058 | | |
| 145,349 | |
Total
prepaid expenses and other current assets | |
$ | 2,017,383 | | |
$ | 1,293,554 | |
NOTE
4. INTANGIBLE ASSETS
As
of June 30, 2024, the Company’s intangible assets consisted of:
SCHEDULE OF INTANGIBLE ASSETS
Definite lived intangible
assets | |
| | |
Balance at January 1, 2024 | |
$ | 210,932 | |
Amortization | |
| (84,376 | ) |
Balance at June 30,
2024 | |
$ | 126,556 | |
For
identified definite lived intangible assets, there was no impairment expense during the three and six months ended June 30, 2024 and
2023. For identified definite lived intangible assets, amortization expense amounted to $42,188 and $42,187 during the three months ended
June 30, 2024 and 2023, respectively and $84,376 and $84,375 during each of the six months ended June 30, 2024 and 2023, respectively.
NOTE
5. PROPERTY AND EQUIPMENT
Property
and equipment consists of the following assets which are located in Calgary, Canada, with all amounts converted into U.S. dollars:
SCHEDULE OF PROPERTY PLANT AND EQUIPMENT NET OF ACCUMULATED DEPRECIATION
| |
June
30, 2024 | | |
December
31, 2023 | |
Lab equipment | |
$ | 808,523 | | |
$ | 836,709 | |
Computer equipment and leasehold improvements | |
| 27,422 | | |
| 28,379 | |
Property and equipment, gross | |
| 27,422 | | |
| 28,379 | |
Less: Accumulated depreciation | |
| (430,831 | ) | |
| (357,711 | ) |
Property
and equipment, net of accumulated depreciation | |
$ | 405,114 | | |
$ | 507,377 | |
Depreciation
expense was $42,591 and $44,331 for the three months ended June 30, 2024 and 2023, respectively and $85,812 and $88,629 for the six months
ended June 30, 2024 and 2023, respectively.
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
NOTE
6. ACCRUED LIABILITIES
As
of June 30, 2024 and December 31, 2023, the accrued liabilities of the Company consisted of the following:
SCHEDULE OF ACCRUED LIABILITIES
| |
June
30, 2024 | | |
December
31, 2023 | |
Product development | |
$ | 79,197 | | |
$ | 139,981 | |
Accrued salaries, wages, and bonuses | |
| 8,634 | | |
| 8,889 | |
Professional fees | |
| 70,542 | | |
| 584,810 | |
Accrued restructuring costs (see Note 8) | |
| — | | |
| 301,645 | |
Accrued income taxes | |
| — | | |
| 22,318 | |
Patent costs | |
| 18,000 | | |
| 18,000 | |
Total
accrued expenses | |
$ | 176,373 | | |
$ | 1,075,643 | |
NOTE
7. SHARE CAPITAL AND OTHER EQUITY INSTRUMENTS
Equity
Distribution Agreement
On
September 1, 2023, the Company entered into the Equity Distribution Agreement (the “Distribution Agreement”), with Canaccord
Genuity LLC (“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 six months ended June 30, 2024, the Company issued 1,668,000 shares of common stock for gross proceeds of $2,392,502 under the Distribution
Agreement, and charged offering costs of $583,713 to additional paid in capital on the unaudited condensed consolidated balance sheet.
As of June 30, 2024 and December 31, 2023, there were deferred offering costs related to the Distribution Agreement of $0 and $171,944,
respectively. As of June 30, 2024, there is $0 available under the Distribution Agreement.
On
December 28, 2023, the Company entered into warrant exercise inducement offer letters (the “Inducement Letters”) with certain
holders (the “Holders”) of the February 2022 Post-Modification Warrants and RD and PIPE preferred investment options to purchase
shares of the Company’s common stock (the “Existing Warrants and Investment Options”) pursuant to which the Holders
agreed to exercise for cash their Existing Warrants and Investment Options to purchase 1,122,000 shares of the Company’s common
stock, in the aggregate, at a reduced exercised price of $1.37 per share (from an original exercise price of $7.78 per share), in exchange
for the Company’s agreement to issue new warrants (the “Inducement Warrants”) to purchase up to 2,244,000 shares of
the Company’s common stock (the “Inducement Warrant Shares”), and the Holders to make a cash payment of $0.125 per
Inducement Warrant share for total proceeds of $280,500. In January 2024, the Company received aggregate gross proceeds of $1,817,640
from the exercise of the Existing Warrants and Investment Options by the Holders and the sale of the Inducement Warrants. Because the
Existing Warrants and Investment Options by the Holders and the sale of the Inducement Warrants that exercised on December 28, 2023 and
unsettled until January 2024, the proceeds are included in the condensed consolidated balance sheet as a subscription receivable as of
December 31, 2023. As of December 31, 2023, 418,000 shares of the Existing Warrants and Investment Options exercised were considered
issued as the Company had the enforceable right to the obtain the cash proceeds, which were in-transit, and the Holders were no longer
able to rescind the exercise election. Due to the beneficial ownership limitation provisions, 704,000 shares of the Existing Warrants
and Investment Options exercised were initially unissued and held in abeyance for the benefit of the Holder until notice is received
from the Holder that the shares may be issued in compliance with such limitation. During the six months ended June 30, 2024, the Company
issued all 704,000 shares of common stock of the 704,000 shares of Existing Warrants and Investment Options exercised that were held
in abeyance due to the beneficial ownership limitation provisions.
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
On
December 28, 2023, the Company entered into warrant exercise inducement offer letters (the “Inducement Letters”) with certain
holders of warrants and preferred investment options. The Inducement Letters prohibit the Company from entering into any variable rate
transaction as defined in the Inducement Letters, including the issuance of (1) any variable priced debt or equity securities or (2)
transactions whereby the Company may issue securities at a future determined price, such as through an at-the-market offering or an equity
line of credit. The variable rate transaction restriction would have expired after six-months from the closing date of December 28, 2023
for the Inducement Letters for an issuance through an at-the-market offering, and one-year for the remaining variable rate transactions,
however the restriction was waived for the at-the-market offering on March 8, 2024 and the equity line on May 3, 2024.
On
March 8, 2024, the Company entered into a series of common stock purchase agreements for the issuance in a registered direct offering
of 228,690 shares of the Company’s common stock to the Holders of the Inducement Warrants. The issuance was made in exchange for
the permanent and irrevocable waiver of the variable rate transaction limitation solely with respect to the entry into and/or issuance
of shares of common stock in an at the market offering contained in the Inducement Letters. The fair value of the shares issued for consideration
of waiving the variable rate transaction limitation was $322,453 and was charged to additional paid in capital, as it is direct and incremental to the Distribution Agreement, on the unaudited condensed
consolidated balance sheet as an offering cost related to the Distribution Agreement.
Lincoln
Park Equity Line
On
November 3, 2023, the Company entered into a Purchase Agreement (the “Purchase Agreement”) and a registration rights agreement
(the “Registration Rights Agreement”), with Lincoln Park Capital Fund, LLC (“Lincoln Park”), pursuant to which
Lincoln Park has committed to purchase up to $10.0 million of the Company’s common stock 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 the Company’s
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 the Company may elect to sell to Lincoln
Park under the Purchase Agreement, if any, will fluctuate based on the market prices of the Company’s Common Stock at the time
the Company elects 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 the Company 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 the Company
will receive from those purchases by Lincoln Park under the Purchase Agreement.
On
May 3, 2024, the Company entered into a series of common stock purchase agreements for the issuance in a registered direct offering of
an aggregate of 458,000 shares of the Company’s common stock, to certain institutional investors. The issuance was made in exchange
for the permanent and irrevocable waiver of the variable rate transaction limitation with respect to any existing or future agreement
by the Company to effect any issuance of shares and issue such shares thereunder, as contained in those certain Inducement Offer Letters,
dated December 28, 2023, between the Company and those certain institutional investors. The Company will not receive any net proceeds
in connection with the offering. The fair value of the shares issued for consideration of waiving the variable rate transaction limitation
was $448,840 and was recorded as deferred offering costs, as direct and incremental to the Purchase Agreement, within prepaid expenses and other current assets on the unaudited condensed
consolidated balance sheet related to the Purchase Agreement.
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
The
common stock purchase agreements contain customary representations and warranties and certain indemnification obligations of the Company.
The common stock purchase agreements also restrict the Company from issuing, entering into any agreement to issue, or announcing the
issuance of the Company’s common stock from the date of the common stock purchase agreements until the earlier of 30 days after
entering into the agreements or at such time as fifteen million (15,000,000) shares of the Company’s common stock have traded in
the open market. The closing of the issuance of the Shares pursuant to the common stock purchase agreements closed on May 3, 2024.
During
the three and six months ended June 30, 2024, the Company had issued 125,000 shares of common stock through the Purchase Agreement for
gross cash proceeds of $82,850 and the Company charged offering costs of $82,850 to additional paid in capital on the unaudited condensed
consolidated balance sheet. As of June 30, 2024 and December 31, 2023, the Company has capitalized deferred offering costs of $763,173
and $395,660, respectively. See Note 9 for shares issued after June 30, 2024.
Stock
Options
Amendment
to 2020 Long-Term Incentive Plan
On
November 2, 2023, the stockholders 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 (i) increased the number of authorized shares reserved
for issuance under the Amended Incentive Plan to a maximum of 350,000, subject to adjustment, and (ii) removed the Evergreen Provision
implemented in the Plan Amendment. During the first quarter of 2024, the Board approved an equitable adjustment to increase the number
of shares available under the Plan by 134,779 shares. As of June 30, 2024, the total number of shares available for grant under the Incentive
Plan was 6,257.
A
summary of the stock option activity under the Company’s incentive plan for the six months ended June 30, 2024 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,
2023 | |
| 30,329 | | |
$ | 57.17 | | |
$ | 77.22 | | |
| 3.4 | | |
$ | — | |
Granted | |
| — | | |
$ | — | | |
$ | — | | |
| | | |
| — | |
Forfeited | |
| (7,247 | ) | |
$ | 39.35 | | |
$ | 54.02 | | |
| | | |
| — | |
Outstanding at June 30, 2024 | |
| 23,082 | | |
$ | 62.77 | | |
$ | 84.51 | | |
| 2.9 | | |
$ | — | |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Exercisable at June 30, 2024 | |
| 21,988 | | |
$ | 65.74 | | |
$ | 88.59 | | |
| 2.5 | | |
$ | — | |
The
Company’s stock based compensation expense, recorded within general and administrative expense in the unaudited condensed consolidated
statement of operations and comprehensive loss, related to stock options for the three months ended June 30, 2024 and 2023 was $414 and
$54,375, respectively.
The
Company’s stock-based compensation expense, recorded within general and administrative expense, related to stock options for the
six months ended June 30, 2024 and 2023 was $(6,268) and $102,461, respectively.
As
of June 30, 2024, the Company had $2,760 in unamortized stock option expense, which will be recognized over a weighted average period
of 1.65 years.
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Issuance
of Restricted Stock Units
The
Company’s activity in restricted stock units was as follows for the six months ended June 30, 2024:
SCHEDULE OF RESTRICTED STOCK UNITS AND AWARDS ACTIVITY
| |
Number
of shares | | |
Weighted
average fair value | |
Non-vested at December 31, 2023 | |
| 140,491 | | |
$ | 28.97 | |
Granted | |
| 251,500 | | |
$ | 0.85 | |
Forfeited | |
| (9,750 | ) | |
$ | 2.87 | |
Vested | |
| (26,125 | ) | |
$ | 2.62 | |
Non-vested at June 30, 2024 | |
| 356,116 | | |
$ | 11.76 | |
For
the three months ended June 30, 2024 and 2023, the Company recorded $369,200 and $825,363, respectively, in stock-based compensation
expense related to restricted stock units, which is a component of both general and administrative and research and development expenses
in the unaudited condensed consolidated statement of operations and comprehensive loss. For the six months ended June 30, 2024 and 2023,
the Company recorded $727,370 and $1,310,112, respectively, in stock-based compensation expense related to restricted stock units, which
is a component of both general and administrative and research and development expenses in the condensed consolidated statement of operations
and comprehensive loss. As of June 30, 2024, the Company had unamortized stock-based compensation costs related to restricted stock units
of $1,478,726 which will be recognized over a weighted average period of 1.71 years. As of June 30, 2024, 41,901 restricted stock units
are vested without shares of common stock being issued, with all of these shares due as of June 30, 2024.
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
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three
Months Ended June 30, | | |
Six
Months Ended June 30, | |
Stock-based compensation expense for RSUs: | |
2024 | | |
2023 | | |
2024 | | |
2023 | |
General and administrative | |
$ | 162,042 | | |
$ | 592,929 | | |
$ | 314,471 | | |
$ | 845,244 | |
Research and development | |
| 207,158 | | |
| 232,434 | | |
| 412,899 | | |
| 464,868 | |
Total | |
$ | 369,200 | | |
$ | 825,363 | | |
$ | 727,370 | | |
$ | 1,310,112 | |
Stock-based compensation
expense for RSUs | |
$ | 369,200 | | |
$ | 825,363 | | |
$ | 727,370 | | |
$ | 1,310,112 | |
Warrants
and Preferred Investment Options
The
following table summarizes information about shares issuable under warrants outstanding at June 30, 2024:
SCHEDULE OF WARRANTS OUTSTANDING
| |
Warrant
shares outstanding | | |
Weighted
average exercise price | | |
Weighted
average remaining life | | |
Intrinsic
value | |
Outstanding at December 31,
2023 | |
| 2,799,213 | | |
$ | 11.79 | | |
| 4.6 | | |
$ | — | |
Exercised | |
| (1,954,000 | ) | |
| 1.37 | | |
| — | | |
$ | — | |
Outstanding at June 30, 2024 | |
| 845,213 | | |
$ | 35.87 | | |
| 3.2 | | |
$ | — | |
| |
| | | |
| | | |
| | | |
| | |
Exercisable at June 30, 2024 | |
| 845,213 | | |
$ | 35.87 | | |
| 3.2 | | |
$ | — | |
The
following table summarizes information about investment options outstanding at June 30, 2024:
SCHEDULE OF WARRANTS AND INVESTMENT OPTIONS
| |
Investment
options outstanding | | |
Weighted
average exercise price | | |
Weighted
average remaining life | | |
Intrinsic
value | |
Outstanding at December 31,
2023 | |
| 70,000 | | |
$ | 10.00 | | |
| 4.1 | | |
$ | — | |
Outstanding at June 30, 2024 | |
| 70,000 | | |
$ | 10.00 | | |
| 3.1 | | |
$ | — | |
| |
| | | |
| | | |
| | | |
| | |
Exercisable at June 30, 2024 | |
| 70,000 | | |
$ | 10.00 | | |
| 3.1 | | |
$ | — | |
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
NOTE
8. 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-002, 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-002 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-002. EB-002, a next-generation proprietary psilocin prodrug, has been recognized as a
New Chemical Entity (NCE) by Australia’s Therapeutic Goods Administration and is currently in preclinical development
targeting the treatment of anxiety disorder. The total cost of the Avance Clinical contract is approximately 3,400,000
AUD, which translates to approximately $2,225,000
USD as of June 30, 2024. As of June 30, 2024, the Company has paid approximately $2,225,000
of the Avance Clinical contract costs and has $251,254
recorded as prepaid assets within prepaid and other current assets, accrued $— recorded as accrued liabilities and $— as
accounts payable on the accompanying condensed consolidated balance sheet. For the three and six months ended June 30, 2024 and
2023, the Company has expensed $(154,354)
and $244,390,
and $354,419
and $355,232,
respectively, in research and development expenses within the accompanying unaudited condensed consolidated statement of operations.
As of June 30, 2024, all payments have been made and the project is substantially completed.
According
to Australian tax law, the Company is allowed an R&D tax credit that reduces a company’s tax bill in Australia for expenses
incurred in R&D subject to certain requirements. The Company’s Australian subsidiary submits R&D tax credit requests annually
for research and development expenses incurred. At June 30, 2024 and December 31, 2023, the Company had a research and development tax
credit receivable of $261,058 and $145,349, respectively, for R&D expenses incurred in Australia, included in prepaid and other current
assets within the accompanying unaudited condensed consolidated statement of operations.
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 patent portfolio acquired and developed under the Vogel-Nathan Purchase Agreement
was sold to undisclosed buyers for an undisclosed sum in the first quarter of 2024. No additional financial or other obligations exist
regarding the Vogel-Nathan Purchase Agreement.
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 one and 12 months. These agreements, in aggregate, commit the Company to approximately $0.1 million in future
cash payments, inclusive of amounts in accounts payable.
Reduction
in Force/Restructuring
In
May 2023, the Company entered into a cost reduction plan, including a reduction in force (“RIF”) 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 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.
In
June 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 received salary
and benefits that is paid out in twelve monthly installments beginning in July 2023, was eligible for his 2023 performance bonus, which
was not achieved, and any outstanding restricted stock units retained their vesting conditions.
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
The
following table summarizes the Reduction in Force/Restructuring activity and ending balance at June 30, 2024 for the remaining severance
payments included in accrued expenses in the consolidated balance sheet:
SCHEDULE OF REDUCTION IN FORCE/RESTRUCTURING ACTIVITY
| |
Accrued
Restructuring Costs | |
January 1, 2024 beginning balance | |
$ | 301,645 | |
Restructuring costs
paid | |
| (301,645 | ) |
June 30, 2024 ending balance | |
$ | — | |
NOTE
9. SUBSEQUENT EVENTS
Subsequent
to June 30, 2024, the Company issued 1,015,477
shares of common stock through the Purchase Agreement
with Lincoln Park for gross cash proceeds of $494,887. As of July 30, 2024, there were no remaining shares available to be issued in
connection with this agreement.
On
July 10, 2024, Akos entered into an Exclusive License Agreement (the “License Agreement”) with Aries Science and Technology,
LLC, an Ohio limited liability company (“Aries”), pursuant to which Akos granted Aries a license of Akos’s patented
radiation dermatitis topical product. The license allows Akos to use the patented formulation to develop pharmaceutical or non-pharmaceutical
products for treating radiation dermatitis suitable for administration to humans or animals. The license is exclusive (subject to certain
exceptions contained in the License Agreement), worldwide, royalty-bearing, and includes the right to sublicense. Akos is entitled to
potential license payments, milestone payments and royalties based on net revenues of the Licensed Product on a licensed product-by-licensed
product and country-by-country basis pursuant to the terms of the Agreement. Aries has the option during the license term, to purchase
the rights to each licensed product (on a licensed product-by-licensed product basis) in the form of an exclusive (as to the applicable
licensed product), fully paid, transferable right and license to the licensed product.
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, and its subsidiaries.
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,” “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
limited study on the effects of medical 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 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 held 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 on Form 10-K for the year ended December 31, 2023. 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 our unique discovery and development platform, The Psybrary™, we have created a robust
intellectual property portfolio of new chemical entities for specific mental health indications. Our lead program, the EVM201 Series,
comprises next generation synthetic prodrugs of the active metabolite, psilocin. We are developing the first product from the EVM201
Series – EB-002 – for the treatment of psychiatric disorders. We are also advancing its second program, the EVM301 Series
– EB 003 – 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
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 anxiety.
We synthesize 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™ we have three different types of molecules, Generation 1 (classic psychedelics),
Generation 2 (new chemical entity pro-drugs of psilocin), and Generation 3 (new chemical entity analogs). The Company has created over
1,000 novel psychedelic molecular compounds and derivatives (“Psychedelic Derivatives”) that are housed in the Psybrary™.
Our current focus is develop our lead molecules EB-002 and EB-003 and to out-license other molecules from the Psybrary™.
Recent
Developments
Equity
Distribution Agreement
During
the six months ended June 30, 2024, the Company issued 1,668,000 shares of common stock for gross proceeds of $2,392,502 under the Distribution
Agreement, and charged offering costs of $583,713 to additional paid in capital on the unaudited condensed consolidated balance sheet.
As of June 30, 2024 and December 31, 2023, there were deferred offering costs related to the Distribution Agreement of $0 and $171,944,
respectively.
On
December 28, 2023, the Company entered into warrant exercise inducement offer letters (the “Inducement Letters”) with certain
holders (the “Holders”) of the February 2022 Post-Modification Warrants and RD and PIPE preferred investment options to purchase
shares of the Company’s common stock (the “Existing Warrants and Investment Options”) pursuant to which the Holders
agreed to exercise for cash their Existing Warrants and Investment Options to purchase 1,122,000 shares of the Company’s common
stock, in the aggregate, at a reduced exercised price of $1.37 per share (from an original exercise price of $7.78 per share), in exchange
for the Company’s agreement to issue new warrants (the “Inducement Warrants”) to purchase up to 2,244,000 shares of
the Company’s common stock (the “Inducement Warrant Shares”), and the Holders to make a cash payment of $0.125 per
Inducement Warrant share for total proceeds of $280,500. In January 2024, the Company received aggregate gross proceeds of $1,817,640
from the exercise of the Existing Warrants and Investment Options by the Holders and the sale of the Inducement Warrants. Because the
Existing Warrants and Investment Options by the Holders and the sale of the Inducement Warrants that exercised on December 28, 2023 and
unsettled until January 2024, the proceeds are included in the condensed consolidated balance sheet as a subscription receivable as of
December 31, 2023. As of December 31, 2023, 418,000 shares of the Existing Warrants and Investment Options exercised were considered
issued as the Company had the enforceable right to the obtain the cash proceeds, which were in-transit, and the Holders were no longer
able to rescind the exercise election. Due to the beneficial ownership limitation provisions, 704,000 shares of the Existing Warrants
and Investment Options exercised were initially unissued and held in abeyance for the benefit of the Holder until notice is received
from the Holder that the shares may be issued in compliance with such limitation. During the six months ended June 30, 2024, the Company
issued all 704,000 shares of common stock of the 704,000 shares of Existing Warrants and Investment Options exercised that were held
in abeyance due to the beneficial ownership limitation provisions.
On
December 28, 2023, the Company entered into warrant exercise inducement offer letters (the “Inducement Letters”) with certain
holders of warrants and preferred investment options. The Inducement Letters prohibit the Company from entering into any variable rate
transaction as defined in the Inducement Letters, including the issuance of (1) any variable priced debt or equity securities or (2)
transactions whereby the Company may issue securities at a future determined price, such as through an at-the-market offering or an equity
line of credit. The variable rate transaction restriction would have expired after six-months from the closing date of December 28, 2023
for the Inducement Letters for an issuance through an at-the-market offering, and one-year for the remaining variable rate transactions,
however the restriction was waived for the at-the-market offering on March 8, 2024 and the equity line on May 3, 2024.
On
March 8, 2024, the Company entered into a series of common stock purchase agreements for the issuance in a registered direct offering
of 228,690 shares of the Company’s common stock, par value $0.01 per share to the Holders of the Inducement Warrants. The issuance
was made in exchange for the permanent and irrevocable waiver of the variable rate transaction limitation solely with respect to the
entry into and/or issuance of shares of common stock in an at the market offering contained in the Inducement Letters. The fair value
of the shares issued for consideration of waiving the variable rate transaction limitation was $322,453 and was charged to additional
paid in capital on the unaudited condensed consolidated balance sheet as an offering cost related to the Distribution Agreement.
Lincoln
Park Equity Line
During
the three and six months ended June 30, 2024, the Company had issued 125,000 shares of common stock through the Purchase Agreement for
gross cash proceeds of $82,850 and the Company charged offering costs of $82,850 to additional paid in capital on the unaudited condensed
consolidated balance sheet. As of June 30, 2024 and December 31, 2023, the Company has capitalized deferred offering costs of $763,173
and $395,660, respectively.
On
May 3, 2024, the Company entered into a series of common stock purchase agreements for the issuance in a registered direct offering of
an aggregate of 458,000 shares of the Company’s common stock, to certain institutional investors. The issuance was made in exchange
for the permanent and irrevocable waiver of the variable rate transaction limitation with respect to any existing or future agreement
by the Company to effect any issuance of shares and issue such shares thereunder, as contained in those certain Inducement Offer Letters,
dated December 28, 2023, between the Company and those certain institutional investors. The Company will not receive any net proceeds
in connection with the offering. The fair value of the shares issued for consideration of waiving the variable rate transaction limitation
was $448,840 and was recorded as deferred offering costs within prepaid expenses and other current assets on the unaudited condensed
consolidated balance sheet related to the Purchase Agreement.
During
July 2024, the Company issued 1,015,477 shares of common stock through the Purchase Agreement with Lincoln Park for gross cash proceeds
of $494,887. As of July 30, 2024, there were no remaining shares available to be issued in connection with this agreement.
Inducement
Warrants
On
February 29, 2024, a Holder of the Inducement Warrants, exercised 1,954,000 Inducement Warrants at an exercise price of $1.37 per share
for 1,954,000 shares of the Company’s common stock for total gross proceeds of $2,676,980.
Results
of Operations
The
following table sets forth information comparing the components of net loss for the three months ended June 30, 2024 and 2023:
| |
For
the Three Months Ended June 30, | |
| |
2024 | | |
2023 | |
Operating expenses | |
| | | |
| | |
General and
administrative | |
$ | 1,297,651 | | |
$ | 3,272,900 | |
Research and development | |
| 515,501 | | |
| 2,395,589 | |
Depreciation and amortization | |
| 84,779 | | |
| 86,518 | |
Total
operating expenses | |
| 1,897,931 | | |
| 5,755,007 | |
| |
| | | |
| | |
Loss
from operations | |
| (1,897,931 | ) | |
| (5,755,007 | ) |
| |
| | | |
| | |
Other income (expense) | |
| | | |
| | |
Change in fair value of
warrant liabilities | |
| 10,805 | | |
| (233,821 | ) |
Change in fair value of
investment option liability | |
| 7,767 | | |
| (1,082,141 | ) |
Change in fair value of
derivative liability | |
| — | | |
| 714,000 | |
Interest income (expense),
net | |
| (35 | ) | |
| 916 | |
Total
other income (expense) | |
| 18,537 | | |
| (601,046 | ) |
| |
| | | |
| | |
Net loss before income taxes | |
$ | (1,879,394 | ) | |
$ | (6,356,053 | ) |
| |
| | | |
| | |
Income tax expense | |
| — | | |
| — | |
| |
| | | |
| | |
Net
loss | |
$ | (1,879,394 | ) | |
$ | (6,356,053 | ) |
General
and Administrative Expenses
Our
general and administrative expenses decreased to $1,297,651 for the three months ended June 30, 2024 from $3,272,900 for the three months
ended June 30, 2023, a decrease of $1,975,249, or 60%. This change was primarily driven by decreases in consulting expenses of $357,747,
salaries and wages of $806,006, stock compensation expense of $484,848, legal fees of $109,403 and accounting fees of $63,919, all primarily
related to the second quarter 2023 reduction in force and no longer pursuing the transfer and spin-off its cannabinoid clinical development
pipeline assets to Akos Biosciences, Inc.
Research
and Development Expenses
Our
research and development expense for the three months ended June 30, 2024 was $515,501 as compared to $2,395,589 for the three months
ended June 30, 2023 with a decrease of $1,880,088, or approximately 78%. This decrease was primarily driven by a decrease in CRO expense
of $531,305, salaries and wages of $564,333, research costs of $722,777 and product development of $124,199.
Depreciation
and Amortization Expense
Depreciation
and amortization expense for the three months ended June 30, 2024 was $84,779 as compared to $86,518 for the three months ended June
30, 2023, with a decrease of $1,739, or approximately 2%.
Change
in Fair Value of Warrant Liabilities
Change
in fair value of warrant liabilities for the three months ended June 30, 2024 resulted in income of $10,805 as compared to an expense
of $233,821 for the three months ended June 30, 2023. The change in fair value of warrant liabilities is due to the exercise of 122,000
of warrants on December 28, 2023, resulting in less warrants outstanding and re-valued at June 30, 2024, as well as, 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.
Change
in Fair Value of Investment Option Liability
Change
in fair value of investment option liability the three months ended June 30, 2024 resulted in income of $7,767 as compared to an expense
of $1,082,141 during the three months ended June 30, 2023. The change in fair value is due to the exercise of 1,000,000 investment options
on December 28, 2023, resulting in less investment options re-valued at June 30, 2024 and a significant decrease in the Company’s
stock price for the three months ended June 30, 2024.
Change
in Fair Value of Derivative Liability
The
Company’s change in fair value of derivative liability is due to the May 2023 redemption which ceased the probability of occurrence
of the Akos spin-off and Akos Series A Preferred Stock redemption.
The
following table sets forth information comparing the components of net loss for the six months ended June 30, 2024 and 2023:
| |
For
the Six Months Ended June | |
| |
2024 | | |
2023 | |
Operating expenses | |
| | | |
| | |
General and
administrative | |
$ | 3,231,404 | | |
$ | 6,192,700 | |
Research and development | |
| 973,656 | | |
| 4,249,981 | |
Depreciation and amortization | |
| 170,188 | | |
| 173,004 | |
Total
operating expenses | |
| 4,375,248 | | |
| 10,615,685 | |
| |
| | | |
| | |
Loss from operations | |
| (4,375,248 | ) | |
| (10,615,685 | ) |
| |
| | | |
| | |
Other income (expense) | |
| | | |
| | |
Change in fair value of
warrant liabilities | |
| 20,844 | | |
| (183,164 | ) |
Change in fair value of
investment option liability | |
| 19,165 | | |
| (962,636 | ) |
Change in fair value of
derivative liability | |
| — | | |
| 727,000 | |
Interest income, net | |
| 661 | | |
| 905 | |
Total
other income (expense) | |
| 40,670 | | |
| (417,895 | ) |
| |
| | | |
| | |
Net loss before income taxes | |
$ | (4,334,578 | ) | |
$ | (11,033,580 | ) |
| |
| | | |
| | |
Income tax expense | |
| (1,731 | ) | |
| — | |
| |
| | | |
| | |
Net
loss | |
$ | (4,336,309 | ) | |
$ | (11,033,580 | ) |
General
and Administrative Expenses
Our
general and administrative expenses decreased to $3,231,404 for the six months ended June 30, 2024 from $6,192,700 for the six months
ended June 30, 2023, a decrease of $2,961,296, or 48%. This change was primarily driven by decreases in consulting expenses of $697,659,
salaries and wages of $1,041,946, stock compensation expense of $639,502, investor relations of $256,219 and accounting fees of $142,950,
all primarily related to the second quarter 2023 reduction in force and no longer pursuing the transfer and spin-off its cannabinoid
clinical development pipeline assets to Akos Biosciences, Inc., and Delaware franchise taxes of $220,075 partially offset by an increase
in director fees of $113,573.
Research
and Development Expenses
Our
research and development expense for the six months ended June 30, 2024 was $973,656 as compared to $4,249,981 for the six months ended
June 30, 2023 with a decrease of $3,276,325, or approximately 77%. This decrease was primarily driven by a decrease salaries and wages
of $1,329,698, research costs of $1,046,750, product development costs of $323,751 and the gain realized related to the Australian R&D
tax incentive of $259,591.
Depreciation
and Amortization Expense
Depreciation
and amortization expense for the six months ended June 30, 2024 was $170,188 as compared to $173,004 for the six months ended June 30,
2023, with a decrease of $2,816, or approximately 2%.
Change
in Fair Value of Warrant Liabilities
Change
in fair value of warrant liabilities for the six months ended June 30, 2024 resulted in income of $20,844 as compared to a loss of $183,164
for the six months ended June 30, 2023. The change in fair value of warrant liabilities is due to the exercise of 122,000 of warrants
on December 28, 2023, resulting in less warrants outstanding and re-valued at June 30, 2024, as well as, 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.
Change
in Fair Value of Investment Option Liability
Change
in fair value of investment option liability the six months ended June 30, 2024 resulted in income of $19,165 as compared to a loss of
$962,636 during the six months ended June 30, 2023. The change in fair value is due to the exercise of 1,000,000 investment options on
December 28, 2023, resulting in less investment options re-valued at June 30, 2024 and a significant decrease in the Company’s
stock price for the six months ended June 30, 2024.
Change
in Fair Value of Derivative Liability
The
Company’s change in fair value of derivative liability is due to the May 2023 redemption which ceased the probability of occurrence
of the Akos spin-off and Akos Series A Preferred Stock redemption.
Going
Concern, Liquidity and Capital Resources
The
Company has incurred a loss since inception resulting in an accumulated deficit of $100,835,827 as of June 30, 2024 and further losses
are anticipated in the development of its business. Further, the Company had operating cash outflows of $5,487,520 for the six months
ended June 30, 2024. For the six months ended June 30, 2024, the Company had a loss from operations of $4,375,248. 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
unaudited condensed consolidated financial statements.
In
assessing the Company’s ability to continue as a going concern, the Company monitors and analyzes its cash and its ability to generate
sufficient cash flow in the future to support its operating and capital expenditure commitments. At June 30, 2024, the Company had cash
of $3,502,551 and working capital of $4,874,594. 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 raising additional working capital through public
or private equity or debt financings or other sources, and may include additional collaborations with third parties as well as disciplined
cash spending. Adequate additional financing may not be available to us on acceptable terms, or at all. Should the Company be unable
to raise sufficient additional capital, the Company may be required to undertake cost-cutting measures including delaying or discontinuing
certain operating activities.
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 unaudited condensed consolidated financial statements. The Company’s
unaudited condensed consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Cash
Flows
Since
inception, we have primarily used our available cash to fund our product development and operations expenditures.
Cash
Flows for the Six Months Ended June 30, 2024 and 2023:
The
following table sets forth a summary of cash flows for the years presented:
| |
For
the Six Months Ended June 30, | |
| |
2024 | | |
2023 | |
Net cash used in operating activities | |
$ | (5,487,520 | ) | |
$ | (9,602,930 | ) |
Net cash provided by investing activities | |
| — | | |
| 11,685 | |
Net cash provided by (used in) financing activities | |
| 6,692,699 | | |
| (1,052,057 | ) |
Effect of Foreign Exchange
Rate on Changes on Cash | |
| 9,395 | | |
| 826 | |
Net increase (decrease)
in cash | |
$ | 1,214,574 | | |
$ | (10,642,476 | ) |
Operating
Activities
Net
cash used in operating activities was $5,487,520 during the six months ended June 30, 2024, which consisted primarily of a net loss adjusted
for non-cash items of $3,485,028 and an increase in prepaid expenses and other current assets of $543,822 and a decrease in accounts
payable and accrued liabilities of $1,458,670.
Net
cash used in operating activities was $9,602,930 during the six months ended June 30, 2023, which consisted primarily of a net loss adjusted
for non-cash items of $8,978,712, an increase in prepaid expenses and other current assets of $1,111,913, offset by an increase in accounts
payable and accrued liabilities of $542,397.
Investing
Activities
Net
cash used in investing activities was $0 during the six months ended June 30, 2024.
Net
cash used in investing activities was $11,685 during the six months ended June 30, 2023, which consisted of proceeds from disposal of
property and equipment of $16,872, offset by the purchase of property and equipment of $5,187.
Financing
Activities
Net
cash provided by financing activities was $6,692,699 during the six months ended June 30, 2024, which consisted of $1,804,819 from the
proceeds received from the stock subscription receivable, $2,676,980 for the exercise of the Inducement Warrants, $2,290,186 for the
common stock sold under the Distribution agreement, net of offering costs, and $82,026 for the common stock sold under the Purchase Agreement,
offset by $161,312 offering costs previously accrued for the Inducement Warrants.
Net
cash used in financing activities was $1,052,057 during the six months ended June 30, 2023, which consisted of the redemption of redeemable
non-controlling interest.
Critical
Accounting Estimates
Our
unaudited condensed consolidated financial statements have been prepared in accordance with U.S. GAAP, which requires us to make estimates, assumptions and judgments that affect the reported amount of assets, liabilities,
costs and expenses and related disclosures. Our critical accounting estimates are those estimates that involve a significant level of
uncertainty at the time the estimate was made, and changes in them have had or are reasonably likely to have a material effect on our
financial condition or results of operations. Accordingly, actual results could differ materially from our estimates. We base our estimates
on past experience and other assumptions that we believe are reasonable under the circumstances, and we evaluate these estimates on an
ongoing basis. Our most critical accounting estimate includes determining the accruals associated with third party providers supporting
research and development efforts.
There
have been no material changes to our critical accounting estimates as compared to the critical accounting estimates disclosed in our
Annual Report on Form 10-K for the year ended December 31, 2023.
Item
3. Quantitative and Qualitative Disclosures About Market Risk
From
inception through June 30, 2024, the Company’s reporting currency is the United States dollar while the functional currency of
certain of the Company’s subsidiaries is the Canadian dollar and Australian dollar. For the reporting periods ended June 30, 2024
and June 30, 2023, 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, 2023, continued to exist and were still considered material weaknesses in our internal control
over financial reporting at June 30, 2024.
As
required by paragraph (b) of Rules 13a-15 and 15d-15 under the Exchange Act, our Chief Executive Officer (our principal executive) and
Chief Financial Officer (our principal financial officer and principal accounting officer) carried out an evaluation of the effectiveness
of the design and operation of our disclosure controls and procedures as of June 30, 2024. Based on this evaluation, and in light of
the material weaknesses found in our internal controls over financial reporting, our Chief Executive Officer and Chief Financial Officer
concluded that our disclosure controls and procedures (as defined in paragraph (e) of Rules 13a-15 and 15d-15 under the Exchange Act)
were not effective as of June 30, 2024.
Management’s
Remediation Plan
As
previously discussed in our Annual Report for the year ended December 31, 2023, management had concluded that our internal control over
financial reporting was not effective as of December 31, 2023, because management identified inadequate segregation of duties to ensure
the processing, review, and authorization of all transactions, including non-routine transactions resulting in deficiencies, which, in
aggregate, amounted to a material weakness in the Company’s internal control over financial reporting.
As
of June 30, 2024, there were control deficiencies that constituted a material weakness in our internal control over financial reporting.
Management has taken, and is taking steps to strengthen our internal control over financial reporting: we have conducted evaluation of
the material weakness to determine the appropriate remedy and have established procedures for documenting disclosures and disclosure
controls.
While
we have taken certain actions to address the material weaknesses identified, additional measures may be necessary as we work to improve
the overall effectiveness of our internal controls over financial reporting.
Changes
in Internal Control over Financial Reporting
Other
than the changes discussed above in the Remediation Plan, there have been no other changes in our internal controls over financial reporting
(as defined in Rule 13a-15(f) and 15d-(f) of the Exchange Act) that occurred during quarter ending June 30, 2024, 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 may be periodically involved in legal proceedings, legal actions and claims arising in the ordinary course of business. We do
not have any pending litigation that, separately or in the aggregate, would, in the opinion of management, have a material adverse effect
on our financial position, results of operations or cash flows.
Item
1A. Risk Factors
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 for the year ended December 31, 2023 as filed with the SEC on March 26, 2024. 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, other than as described below, there have been no material changes to the risk
factors disclosed in the Company’s Annual Report.
In
the event that we fail to regain compliance with the listing requirements of The Nasdaq Capital Market or satisfy any of the listing
requirements of Nasdaq, our common stock may be delisted, which could affect our market price and liquidity.
Our
common stock is listed on Nasdaq. For continued listing on Nasdaq, we will be required to comply with the continued listing requirements,
including the minimum market capitalization standard, the stockholders’ equity requirement, the corporate governance requirements
and the minimum closing bid price requirement, among other requirements. On May 16, 2024, the Company received a letter from the Listing
Qualifications Department of the Nasdaq Stock Market stating that because the closing bid price for the Company’s common stock
listed on Nasdaq was below $1.00 for 30 consecutive business days, the Company no longer meets the minimum bid price requirement for
continued listing on the Nasdaq Capital Market (the “Minimum Bid Price Requirement”). The Company has a period of 180 calendar
days from May 16, 2024, or until November 12, 2024, to regain compliance with the Minimum Bid Price Requirement. If at any time before
November 12, 2024, the bid price of the Company’s common stock closes at or above $1.00 per share for a minimum of 10 consecutive
business days, Nasdaq will provide written notification that the Company has achieved compliance with the Minimum Bid Price Requirement.
In
the event that we fail to regain compliance with the Minimum Bid Price Requirement or satisfy any of the listing requirements of Nasdaq,
our common stock may be delisted. We will have an opportunity to appeal the determination to a Hearings Panel, but we cannot guarantee
that such appeal will be successful. If we are unable to list on Nasdaq, we would likely be more difficult to trade in or obtain accurate
quotations as to the market price of our common stock. If our common stock is delisted from trading on Nasdaq, and we are not able to
list our common stock on another exchange or to have it quoted on Nasdaq, our securities could be quoted on the OTC Bulletin Board or
on the “pink sheets.” As a result, we could face significant adverse consequences including, without limitation:
● |
a
limited availability of market quotations for our securities; |
|
|
● |
a
determination that our common stock is a “penny stock” which will require brokers trading in our common stock to adhere
to more stringent rules and possibly result in a reduced level of trading activity in the secondary trading market for our securities; |
|
|
● |
a
limited amount of news and analyst coverage for our Company; and |
|
|
● |
a
decreased ability to issue additional securities (including pursuant to short-form registration statements on Form S-3 or obtain
additional financing in the future). |
Item
2. Unregistered Sales of Equity Securities and Use of Proceeds
None.
Item
3. Defaults Upon Senior Securities
None.
Item
4. Mine Safety Disclosures
Not
applicable.
Item
5. Other Information
None.
Item
6. Exhibits
INDEX
TO EXHIBITS
SIGNATURES
Pursuant
to the requirements of Section 13 or 15(d) of the Exchange Act of 1934, the registrant has duly caused this report to be signed on its
behalf by the undersigned, thereunto duly authorized.
|
ENVERIC
BIOSCIENCES, INC. |
|
|
|
August
12, 2024 |
By: |
/s/
Dr. Joseph Tucker |
|
|
Joseph
Tucker, Ph.D |
|
|
Chief
Executive Officer |
|
|
(Principal
Executive Officer) |
|
|
|
August
12, 2024 |
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:
August 12, 2024 |
/s/
Dr. Joseph Tucker |
|
Joseph
Tucker, Ph.D. |
|
Chief
Executive Officer (Principal 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:
August 12, 2024 |
/s/
Kevin Coveney |
|
Kevin
Coveney |
|
Chief
Financial Officer (Principal Financial and Accounting 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 June 30,
2024, 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:
August 12, 2024
|
By:
|
/s/
Dr. Joseph Tucker |
|
|
Joseph
Tucker, Ph.D. |
|
|
Chief
Executive Officer |
|
|
(Principal
Executive Officer) |
|
|
|
|
By:
|
/s/
Kevin Coveney |
|
|
Kevin
Coveney |
|
|
Chief
Financial Officer |
|
|
(Principal
Financial and Accounting Officer) |
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v3.24.2.u1
Condensed Consolidated Balance Sheets - USD ($)
|
Jun. 30, 2024 |
Dec. 31, 2023 |
Current assets: |
|
|
Cash |
$ 3,502,551
|
$ 2,287,977
|
Prepaid expenses and other current assets |
2,017,383
|
1,293,554
|
Total current assets |
5,519,934
|
3,581,531
|
Other assets: |
|
|
Property and equipment, net |
405,114
|
507,377
|
Intangible assets, net |
126,556
|
210,932
|
Total other assets |
531,670
|
718,309
|
Total assets |
6,051,604
|
4,299,840
|
Current liabilities: |
|
|
Accounts payable |
459,898
|
1,218,783
|
Accrued liabilities |
176,373
|
1,075,643
|
Investment option liability |
4,443
|
23,608
|
Warrant liability |
4,626
|
25,470
|
Total current liabilities |
645,340
|
2,343,504
|
Commitments and contingencies (Note 8) |
|
|
Mezzanine equity |
|
|
Series C redeemable preferred stock, $0.01 par value, 100,000 shares authorized, and 0 shares issued and outstanding as of June 30, 2024 and December 31, 2023 |
|
|
Total mezzanine equity |
|
|
Shareholders’ equity |
|
|
Preferred stock, $0.01 par value, 20,000,000 shares authorized; Series B preferred stock, $0.01 par value, 3,600,000 shares authorized, 0 shares issued and outstanding as of June 30, 2024 and December 31, 2023 |
|
|
Common stock, $0.01 par value, 100,000,000 shares authorized, 7,878,568 and 2,739,315 shares issued and outstanding as of June 30, 2024 and December 31, 2023 |
78,785
|
27,392
|
Additional paid-in capital |
106,729,801
|
100,815,851
|
Stock subscription receivable |
|
(1,817,640)
|
Accumulated deficit |
(100,835,827)
|
(96,499,518)
|
Accumulated other comprehensive loss |
(566,495)
|
(569,749)
|
Total shareholders’ equity |
5,406,264
|
1,956,336
|
Total liabilities, mezzanine equity, and shareholders’ equity |
$ 6,051,604
|
$ 4,299,840
|
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v3.24.2.u1
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares
|
Jun. 30, 2024 |
Dec. 31, 2023 |
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 |
7,878,568
|
2,739,315
|
Common stock, shares outstanding |
7,878,568
|
2,739,315
|
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 |
- DefinitionFace amount or stated value per share of common stock.
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v3.24.2.u1
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Operating expenses |
|
|
|
|
General and administrative |
$ 1,297,651
|
$ 3,272,900
|
$ 3,231,404
|
$ 6,192,700
|
Research and development |
515,501
|
2,395,589
|
973,656
|
4,249,981
|
Depreciation and amortization |
84,779
|
86,518
|
170,188
|
173,004
|
Total operating expenses |
1,897,931
|
5,755,007
|
4,375,248
|
10,615,685
|
Loss from operations |
(1,897,931)
|
(5,755,007)
|
(4,375,248)
|
(10,615,685)
|
Other income (expense) |
|
|
|
|
Change in fair value of warrant liabilities |
10,805
|
(233,821)
|
20,844
|
(183,164)
|
Change in fair value of investment option liability |
7,767
|
(1,082,141)
|
19,165
|
(962,636)
|
Change in fair value of derivative liability |
|
714,000
|
|
727,000
|
Interest income (expense), net |
(35)
|
916
|
661
|
905
|
Total other income (expense) |
18,537
|
(601,046)
|
40,670
|
(417,895)
|
Net loss before income taxes |
(1,879,394)
|
(6,356,053)
|
(4,334,578)
|
(11,033,580)
|
Income tax expense |
|
|
(1,731)
|
|
Net loss |
(1,879,394)
|
(6,356,053)
|
(4,336,309)
|
(11,033,580)
|
Less preferred dividends attributable to non-controlling interest |
|
6,712
|
|
19,041
|
Less deemed dividends attributable to accretion of embedded derivative at redemption value |
|
36,997
|
|
147,988
|
Net loss attributable to shareholders |
(1,879,394)
|
(6,399,762)
|
(4,336,309)
|
(11,200,609)
|
Other comprehensive loss |
|
|
|
|
Foreign currency translation |
(14,652)
|
(11,286)
|
3,254
|
(9,318)
|
Comprehensive loss |
$ (1,894,046)
|
$ (6,411,048)
|
$ (4,333,055)
|
$ (11,209,927)
|
Net loss per share - basic |
$ (0.25)
|
$ (3.04)
|
$ (0.75)
|
$ (5.35)
|
Net loss per share - diluted |
$ (0.25)
|
$ (3.04)
|
$ (0.75)
|
$ (5.35)
|
Weighted average shares outstanding, basic |
7,587,851
|
2,107,583
|
5,794,653
|
2,093,008
|
Weighted average shares outstanding, diluted |
7,587,851
|
2,107,583
|
5,794,653
|
2,093,008
|
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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v3.24.2.u1
Condensed Consolidated Statements of Changes in Mezzanine Equity and Shareholders' Equity (Unaudited) - USD ($)
|
Redeemable Noncontrolling Interest [Member] |
Mezzanine Equity [Member] |
Common Stock [Member] |
Additional Paid-in Capital [Member] |
Subscription Receivable [Member] |
Retained Earnings [Member] |
AOCI Attributable to Parent [Member] |
Total |
Balance value at Dec. 31, 2022 |
$ 885,028
|
$ 885,028
|
$ 20,782
|
$ 94,395,662
|
|
$ (79,207,786)
|
$ (536,734)
|
$ 14,671,924
|
Beginning balance, shares at Dec. 31, 2022 |
|
|
2,078,271
|
|
|
|
|
|
Mezzanine equity balance, shares at Dec. 31, 2022 |
1,000
|
|
|
|
|
|
|
|
Stock-based compensation |
|
|
|
532,835
|
|
|
|
532,835
|
Foreign exchange translation loss |
|
|
|
|
|
|
1,968
|
1,968
|
Net loss |
|
|
|
|
|
(4,677,527)
|
|
(4,677,527)
|
Preferred dividends attributable to redeemable |
12,329
|
12,329
|
|
(12,329)
|
|
|
|
(12,329)
|
Accretion of embedded derivative to redemption value |
110,991
|
110,991
|
|
(110,991)
|
|
|
|
(110,991)
|
Balance value at Mar. 31, 2023 |
1,008,348
|
1,008,348
|
$ 20,782
|
94,805,177
|
|
(83,885,313)
|
(534,766)
|
10,405,880
|
Ending balance, shares at Mar. 31, 2023 |
|
|
2,078,271
|
|
|
|
|
|
Balance value at Dec. 31, 2022 |
$ 885,028
|
885,028
|
$ 20,782
|
94,395,662
|
|
(79,207,786)
|
(536,734)
|
14,671,924
|
Beginning balance, shares at Dec. 31, 2022 |
|
|
2,078,271
|
|
|
|
|
|
Mezzanine equity balance, shares at Dec. 31, 2022 |
1,000
|
|
|
|
|
|
|
|
Foreign exchange translation loss |
|
|
|
|
|
|
|
(9,318)
|
Net loss |
|
|
|
|
|
|
|
(11,033,580)
|
Preferred dividends attributable to redeemable |
|
|
|
|
|
|
|
(19,041)
|
Accretion of embedded derivative to redemption value |
|
|
|
|
|
|
|
(147,988)
|
Balance value at Jun. 30, 2023 |
|
|
$ 21,417
|
95,640,571
|
|
(90,241,366)
|
(546,052)
|
4,874,570
|
Ending balance, shares at Jun. 30, 2023 |
|
|
2,141,782
|
|
|
|
|
|
Mezzanine equity balance, shares at Jun. 30, 2023 |
|
|
|
|
|
|
|
|
Balance value at Dec. 31, 2022 |
$ 885,028
|
885,028
|
$ 20,782
|
94,395,662
|
|
(79,207,786)
|
(536,734)
|
14,671,924
|
Beginning balance, shares at Dec. 31, 2022 |
|
|
2,078,271
|
|
|
|
|
|
Mezzanine equity balance, shares at Dec. 31, 2022 |
1,000
|
|
|
|
|
|
|
|
Proceeds from the subscription receivable related to the exercise of warrants and preferred investment options and issuance of common stock in abeyance, shares |
|
|
418,000
|
|
|
|
|
|
Balance value at Dec. 31, 2023 |
|
|
$ 27,392
|
100,815,851
|
$ (1,817,640)
|
(96,499,518)
|
(569,749)
|
1,956,336
|
Ending balance, shares at Dec. 31, 2023 |
|
|
2,739,315
|
|
|
|
|
|
Balance value at Mar. 31, 2023 |
1,008,348
|
1,008,348
|
$ 20,782
|
94,805,177
|
|
(83,885,313)
|
(534,766)
|
10,405,880
|
Beginning balance, shares at Mar. 31, 2023 |
|
|
2,078,271
|
|
|
|
|
|
Stock-based compensation |
|
|
|
879,738
|
|
|
|
879,738
|
Foreign exchange translation loss |
|
|
|
|
|
|
(11,286)
|
(11,286)
|
Net loss |
|
|
|
|
|
(6,356,053)
|
|
(6,356,053)
|
Preferred dividends attributable to redeemable |
6,712
|
6,712
|
|
(6,712)
|
|
|
|
(6,712)
|
Accretion of embedded derivative to redemption value |
36,997
|
36,997
|
|
(36,997)
|
|
|
|
(36,997)
|
Redemption of Series A preferred stock |
$ (1,052,057)
|
(1,052,057)
|
|
|
|
|
|
|
Redemption of Series A preferred stock, shares |
(1,000)
|
|
|
|
|
|
|
|
Issuance of common shares in exchange for RSU conversions from the reduction in force |
|
|
$ 635
|
(635)
|
|
|
|
|
Issuance of common shares in exchange for RSU conversions from the reduction in force, shares |
|
|
63,511
|
|
|
|
|
|
Balance value at Jun. 30, 2023 |
|
|
$ 21,417
|
95,640,571
|
|
(90,241,366)
|
(546,052)
|
4,874,570
|
Ending balance, shares at Jun. 30, 2023 |
|
|
2,141,782
|
|
|
|
|
|
Mezzanine equity balance, shares at Jun. 30, 2023 |
|
|
|
|
|
|
|
|
Balance value at Dec. 31, 2023 |
|
|
$ 27,392
|
100,815,851
|
(1,817,640)
|
(96,499,518)
|
(569,749)
|
1,956,336
|
Beginning balance, shares at Dec. 31, 2023 |
|
|
2,739,315
|
|
|
|
|
|
Stock-based compensation |
|
|
|
351,488
|
|
|
|
351,488
|
Common stock sold under the Purchase Agreement, net of offering costs of $82,850 |
|
|
$ 16,680
|
1,792,109
|
|
|
|
1,808,789
|
Common stock sold under the Equity Distribution Agreement, shares |
|
|
1,668,000
|
|
|
|
|
|
Issuance of direct offering shares (see Note 7) |
|
|
$ 2,287
|
320,166
|
|
|
|
322,453
|
Issuance of direct offering shares, shares |
|
|
228,690
|
|
|
|
|
|
Exercise of Inducement Warrants for common stock |
|
|
$ 19,540
|
2,657,440
|
|
|
|
2,676,980
|
Exercise of Inducement Warrants for common stock, shares |
|
|
1,954,000
|
|
|
|
|
|
Proceeds from the subscription receivable related to the issuance of Inducement Warrants, net of offering costs of $12,821 |
|
|
|
(12,821)
|
280,500
|
|
|
267,679
|
Proceeds from the subscription receivable related to the exercise of warrants and preferred investment options and issuance of common stock in abeyance |
|
|
$ 7,040
|
(7,040)
|
1,537,140
|
|
|
1,537,140
|
Proceeds from the subscription receivable related to the exercise of warrants and preferred investment options and issuance of common stock in abeyance, shares |
|
|
704,000
|
|
|
|
|
|
Foreign exchange translation loss |
|
|
|
|
|
|
17,906
|
17,906
|
Net loss |
|
|
|
|
|
(2,456,915)
|
|
(2,456,915)
|
Balance value at Mar. 31, 2024 |
|
|
$ 72,939
|
105,917,193
|
|
(98,956,433)
|
(551,843)
|
6,481,856
|
Ending balance, shares at Mar. 31, 2024 |
|
|
7,294,005
|
|
|
|
|
|
Balance value at Dec. 31, 2023 |
|
|
$ 27,392
|
100,815,851
|
(1,817,640)
|
(96,499,518)
|
(569,749)
|
1,956,336
|
Beginning balance, shares at Dec. 31, 2023 |
|
|
2,739,315
|
|
|
|
|
|
Foreign exchange translation loss |
|
|
|
|
|
|
|
3,254
|
Net loss |
|
|
|
|
|
|
|
(4,336,309)
|
Preferred dividends attributable to redeemable |
|
|
|
|
|
|
|
|
Accretion of embedded derivative to redemption value |
|
|
|
|
|
|
|
|
Balance value at Jun. 30, 2024 |
|
|
$ 78,785
|
106,729,801
|
|
(100,835,827)
|
(566,495)
|
5,406,264
|
Ending balance, shares at Jun. 30, 2024 |
|
|
7,878,568
|
|
|
|
|
|
Balance value at Mar. 31, 2024 |
|
|
$ 72,939
|
105,917,193
|
|
(98,956,433)
|
(551,843)
|
6,481,856
|
Beginning balance, shares at Mar. 31, 2024 |
|
|
7,294,005
|
|
|
|
|
|
Stock-based compensation |
|
|
|
369,614
|
|
|
|
369,614
|
Common stock sold under the Purchase Agreement, net of offering costs of $82,850 |
|
|
$ 1,250
|
(1,250)
|
|
|
|
|
Common stock sold under the Equity Distribution Agreement, shares |
|
|
125,000
|
|
|
|
|
|
Issuance of direct offering shares (see Note 7) |
|
|
$ 4,580
|
444,260
|
|
|
|
448,840
|
Issuance of direct offering shares, shares |
|
|
458,000
|
|
|
|
|
|
Foreign exchange translation loss |
|
|
|
|
|
|
(14,652)
|
(14,652)
|
Net loss |
|
|
|
|
|
(1,879,394)
|
|
(1,879,394)
|
Issuance of common shares for vested RSU |
|
|
$ 16
|
(16)
|
|
|
|
|
Issuance of common shares for vested RSU, shares |
|
|
1,563
|
|
|
|
|
|
Balance value at Jun. 30, 2024 |
|
|
$ 78,785
|
$ 106,729,801
|
|
$ (100,835,827)
|
$ (566,495)
|
$ 5,406,264
|
Ending balance, shares at Jun. 30, 2024 |
|
|
7,878,568
|
|
|
|
|
|
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Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Cash Flows From Operating Activities: |
|
|
|
Net loss |
$ (6,356,053)
|
$ (4,336,309)
|
$ (11,033,580)
|
Adjustments to reconcile net loss to cash used in operating activities |
|
|
|
Change in fair value of warrant liability |
233,821
|
(20,844)
|
183,164
|
Change in fair value of investment option liability |
1,082,141
|
(19,165)
|
962,636
|
Change in fair value of derivative liability |
(714,000)
|
|
(727,000)
|
Stock-based compensation |
|
721,102
|
1,412,573
|
Amortization of right of use asset |
|
|
54,703
|
Amortization of intangibles |
42,187
|
84,376
|
84,375
|
Depreciation expense |
44,331
|
85,812
|
88,629
|
Gain on disposal of property and equipment |
|
|
(4,212)
|
Change in operating assets and liabilities: |
|
|
|
Prepaid expenses and other current assets |
|
(543,822)
|
(1,111,913)
|
Accounts payable and accrued liabilities |
|
(1,458,670)
|
542,397
|
Right-of-use operating lease asset and obligation |
|
|
(54,702)
|
Net cash used in operating activities |
|
(5,487,520)
|
(9,602,930)
|
Cash Flows From Investing Activities: |
|
|
|
Purchases of property and equipment |
|
|
(5,187)
|
Proceeds from disposal of property and equipment |
|
|
16,872
|
Net cash provided by investing activities |
|
|
11,685
|
Cash Flows From Financing Activities: |
|
|
|
Proceeds from the subscription receivable related to the issuance of Inducement Warrants and the exercise of warrants and preferred investment options |
|
1,804,819
|
|
Proceeds from exercise of Inducement Warrants |
|
2,676,980
|
|
Proceeds from common stock sold under the Equity Distribution Agreement, net of offering costs |
|
2,290,186
|
|
Proceeds from common stock sold under the Purchase Agreement, net of offering costs |
|
82,026
|
|
Payment for offering costs previously accrued |
|
(161,312)
|
|
Redemption of Series A Preferred Stock |
|
|
(1,052,057)
|
Net cash provided by (used in) financing activities |
|
6,692,699
|
(1,052,057)
|
Effect of Foreign Exchange Rate on Changes on Cash |
|
9,395
|
826
|
Net increase (decrease) in cash |
|
1,214,574
|
(10,642,476)
|
Cash at beginning of period |
|
2,287,977
|
17,723,884
|
Cash at end of period |
7,081,408
|
3,502,551
|
7,081,408
|
Supplemental disclosure of cash and non-cash transactions: |
|
|
|
Cash paid for interest |
|
|
11
|
Income taxes paid |
|
24,001
|
|
Offering costs accrued not paid |
|
149
|
|
Deferred offering costs charged to offering costs |
|
240,969
|
|
Issuance of common shares for offering costs |
|
771,293
|
|
Preferred dividends attributable to redeemable non-controlling interest |
6,712
|
|
19,041
|
Accretion of embedded derivative to redemption value |
$ 36,997
|
|
$ 147,988
|
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v3.24.2.u1
Pay vs Performance Disclosure - USD ($)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Mar. 31, 2024 |
Jun. 30, 2023 |
Mar. 31, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Pay vs Performance Disclosure [Table] |
|
|
|
|
|
|
Net Income (Loss) |
$ (1,879,394)
|
$ (2,456,915)
|
$ (6,356,053)
|
$ (4,677,527)
|
$ (4,336,309)
|
$ (11,033,580)
|
X |
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v3.24.2.u1
BUSINESS AND LIQUIDITY AND OTHER UNCERTAINTIES
|
6 Months Ended |
Jun. 30, 2024 |
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., MagicMed Industries, Inc. (“MagicMed”), Enveric Biosciences Canada, Inc., Akos Biosciences, Inc.
(“Akos”), 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-002 (formerly EB-373) – for the treatment of psychiatric disorders. Enveric is also advancing its product EB-003
from the EVM301 Series, which is 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.
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, N,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™
the Company has three different types of molecules, Generation 1 (classic psychedelics), Generation 2 (new chemical entity pro-drugs
of psilocin), and Generation 3 (new chemical entity analogs). The Company has created over 1000 novel psychedelic molecular compounds
and derivatives that are housed in the Psybrary™. The Company’s current focus is to develop its lead molecules, EB-002 and
EB-003, and to outlicense other molecules from 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.
Going
Concern, Liquidity and Other Uncertainties
The
Company has incurred a loss since inception resulting in an accumulated deficit of $100,835,827 as of June 30, 2024, and further losses
are anticipated in the development of its business. For the six months ended June 30, 2024, the Company has operating cash outflows of
$5,487,520 and had a loss from operations of $4,375,248. Being a research and development company, since inception, 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 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 unaudited condensed consolidated financial statements.
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
In
assessing the Company’s ability to continue as a going concern, the Company monitors and analyzes its cash and its ability to generate
sufficient cash flow in the future to support its operating and capital expenditure commitments. At June 30, 2024, the Company had cash
of $3,502,551 and working capital of $4,874,594. The Company’s current cash on hand is not sufficient to satisfy its operating
cash needs for the 12 months from the filing of this Quarterly Report on Form 10-Q. These conditions raise substantial doubt regarding
the Company’s ability to continue as a going concern for a period of one year after the date the financial statements are issued.
Management’s plan to alleviate the conditions that raise substantial doubt include raising additional working capital through public
or private equity or debt financings or other sources, the Purchase Agreement with Lincoln Park (see Note 7 and 9), subject to registration,
and may include additional collaborations with third parties as well as disciplined cash spending. Adequate additional financing may
not be available to us on acceptable terms, or at all. Should the Company be unable to raise sufficient additional capital, the Company
may be required to undertake cost-cutting measures including delaying or discontinuing certain operating activities.
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 unaudited condensed consolidated 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.
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.
Nasdaq
Notice
On
November 21, 2023, the Company received a letter from the Listing Qualifications Department of the Nasdaq Stock Market (“Nasdaq”)
stating that as of September 30, 2023, the Company did not meet the minimum of $2,500,000 in stockholders’ equity required for
continued listing pursuant to Nasdaq Listing Rule 5550(b)(1). On February 6, 2024, the Company received a letter from Nasdaq, granting
the Company an extension to regain compliance with the minimum stockholders’ equity requirement by May 20, 2024. On May 21, 2024,
the Company received a letter from Nasdaq notifying the Company that it regained compliance with the minimum stockholders’ equity
requirement for continued listing on the Nasdaq.
On
May 16, 2024, the Company received a letter from Nasdaq’s Listing Qualifications Department stating
that because the closing bid price for the Company’s common stock listed on Nasdaq was below $1.00
for 30 consecutive business days, the Company no longer meets the minimum bid price requirement for continued listing on the Nasdaq
Capital Market (the “Minimum Bid Price Requirement”). The Company has a period of 180 calendar days from May 16, 2024,
or until November 12, 2024, to regain compliance with the Minimum Bid Price Requirement. If at any time before November 12, 2024,
the bid price of the Company’s common stock closes at or above $1.00
per share for a minimum of 10 consecutive business days, Nasdaq will provide written notification that the Company has achieved
compliance with the Minimum Bid Price Requirement.
|
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v3.24.2.u1
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
|
6 Months Ended |
Jun. 30, 2024 |
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 six months ended June 30, 2024 are not necessarily indicative of the results that may be expected for the year ending
December 31, 2024. These unaudited condensed consolidated financial statements should be read in conjunction with the consolidated financial
statements for the year ended December 31, 2023, 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 26, 2024.
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
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, 2023. There were no significant changes to these accounting policies during the
three and six months ended June 30, 2024.
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, the
valuation of warrants and preferred investment options, and the valuation of stock-based compensation and accruals associated with
third party providers supporting research and development efforts. Actual results could differ from those estimates.
Reclassification
Certain
reclassifications have been made to the prior period’s unaudited condensed consolidated financial statements in order to conform
to the current year presentation. In the prior year, the Company included certain investor related expenses were included within research
and development on the unaudited condensed consolidated statements of operations. These expenses were reclassified to general and administrative
expenses in the current year. This reclassification had no effect on the Company’s previously reported results of operations, changes
in equity, or cash flows.
Foreign
Currency Translation
From
inception through June 30, 2024, 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 June 30, 2024
and 2023, 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 unaudited condensed consolidated statements of shareholders’ equity as a component of accumulated other comprehensive loss.
The
Company has not entered into any financial derivative instruments that expose it to material market risk, including any instruments designed
to hedge the impact of foreign currency exposures. The Company may, however, hedge such exposure to foreign currency exchange fluctuations
in the future.
Adjustments
that arise from exchange rate changes on transactions denominated in a currency other than the local currency are included in other comprehensive
loss in the unaudited condensed consolidated statements of operations and comprehensive loss as incurred.
Concentration
of Credit Risk
Financial
instruments that potentially subject the Company to concentrations of credit risk consist of cash accounts in a financial institution,
which at times, may exceed the federal depository insurance coverage of $250,000 in the United States and Australia and $100,000 in Canada.
The Company has not experienced losses on these accounts, and management believes the Company is not exposed to significant risks on
such accounts. As of June 30, 2024, the Company had greater than $250,000 at United States financial institutions, less than $250,000
at Australian financial institutions, and less than $100,000 at Canadian financial institutions.
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Research
and Development
Research
and development expenses are charged to operations as incurred. Research and development expenses include, among other things, internal
and external costs associated with preclinical development, pre-commercialization manufacturing expenses, and clinical trials. The Company
accrues for costs incurred as the services are being provided by monitoring the status of the trial or services provided and the invoices
received from its external service providers. In the case of clinical trials, a portion of the estimated cost normally relates to the
projected cost to treat a patient in the trials, and this cost is recognized based on the number of patients enrolled in the trial. As
actual costs become known, the Company adjusts its accruals accordingly.
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.
Research
and Development Tax Incentive Receivable
The
Company, through its wholly-owned subsidiary in Australia, participates in the Australian research and development tax incentive program,
such that a percentage of the Company’s qualifying research and development expenditures are reimbursed by the Australian government,
and such incentives are reflected as a reduction of research and development expense. The Australian research and development tax incentive
is recognized when there is reasonable assurance that the incentive will be received, the relevant expenditure has been incurred and
the amount of the consideration can be reliably measured. At each period end, management estimates the reimbursement available to the
Company based on available information at the time.
Net
Loss per Share
Basic
net loss per share is computed by dividing net loss by the weighted average number of shares of common stock outstanding during the period.
Diluted earnings per share is computed using the weighted average number of common shares and, if dilutive, potential common shares outstanding
during the period. Potential common shares consist of the incremental common shares issuable upon the exercise of stock options and warrants
(using the treasury stock method). The computation of basic net loss per share for the three and six months ended June 30, 2024 and 2023
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 for the three and
six months ended June 30, 2024 and 2023 because the effect of their inclusion would have been anti-dilutive.
SCHEDULE OF POTENTIALLY DILUTIVE SECURITIES
| |
For
the three and six months ended June 30, 2024 | | |
For
the three and six months ended June 30, 2023 | |
Warrants to purchase shares of
common stock | |
| 845,213 | | |
| 655,463 | |
Restricted stock units - vested and unissued | |
| 41,901 | | |
| 55,622 | |
Restricted stock units - unvested | |
| 356,116 | | |
| 180,115 | |
Restricted stock awards - vested and unissued | |
| — | | |
| 708 | |
Investment options to purchase shares of common
stock | |
| 70,000 | | |
| 1,070,000 | |
Options to purchase
shares of common stock | |
| 23,082 | | |
| 36,579 | |
Total potentially dilutive
securities | |
| 1,336,312 | | |
| 1,998,487 | |
Recent
Accounting Pronouncements
In
November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. ASU
2023-07 updates reportable segment disclosure requirements primarily through enhanced disclosures about significant segment expenses.
ASU 2023-07 is effective for all entities for fiscal years beginning after December 15, 2023, and for interim periods within fiscal years
beginning after December 15, 2024. Early adoption is permitted. The amendments should be applied retrospectively to all prior periods
presented in the financial statements. The Company is currently assessing the potential impacts of ASU 2023-07, however as the Company
currently has one reportable segment, does not expect this guidance will not have a material impact on its unaudited
condensed consolidated financial statements.
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
In
December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which amends the
disclosure to address investor requests for more transparency about income tax information through improvements to income tax disclosures
primarily related to the rate reconciliation and income taxes paid information and includes certain other amendments to improve the effectiveness
of income tax disclosures. The ASU is effective on a prospective basis for annual periods beginning after December 15, 2024, and early
adoption and retrospective application are permitted. Early adoption is permitted. The Company is currently assessing potential impacts
of ASU 2023-09 and does not expect the adoption of this guidance will have a material impact on its unaudited condensed consolidated
financial statements and disclosures.
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v3.24.2.u1
PREPAID EXPENSES AND OTHER CURRENT ASSETS
|
6 Months Ended |
Jun. 30, 2024 |
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 June 30, 2024 and December 31, 2023, the prepaid expenses and other current assets of the Company consisted of the following:
SCHEDULE OF PREPAID EXPENSES AND OTHER CURRENT ASSETS
| |
June
30, 2024 | | |
December
31, 2023 | |
Prepaid research and development | |
$ | 257,218 | | |
$ | 46,320 | |
Prepaid value-added taxes | |
| 241,269 | | |
| 243,429 | |
Prepaid insurance | |
| 375,215 | | |
| 149,559 | |
Prepaid other | |
| 81,192 | | |
| 62,036 | |
Deferred offering costs (see Note 7) | |
| 763,173 | | |
| 567,603 | |
Franchise tax receivable | |
| 38,258 | | |
| 79,258 | |
R&D tax incentive
receivable | |
| 261,058 | | |
| 145,349 | |
Total
prepaid expenses and other current assets | |
$ | 2,017,383 | | |
$ | 1,293,554 | |
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v3.24.2.u1
INTANGIBLE ASSETS
|
6 Months Ended |
Jun. 30, 2024 |
Goodwill and Intangible Assets Disclosure [Abstract] |
|
INTANGIBLE ASSETS |
NOTE
4. INTANGIBLE ASSETS
As
of June 30, 2024, the Company’s intangible assets consisted of:
SCHEDULE OF INTANGIBLE ASSETS
Definite lived intangible
assets | |
| | |
Balance at January 1, 2024 | |
$ | 210,932 | |
Amortization | |
| (84,376 | ) |
Balance at June 30,
2024 | |
$ | 126,556 | |
For
identified definite lived intangible assets, there was no impairment expense during the three and six months ended June 30, 2024 and
2023. For identified definite lived intangible assets, amortization expense amounted to $42,188 and $42,187 during the three months ended
June 30, 2024 and 2023, respectively and $84,376 and $84,375 during each of the six months ended June 30, 2024 and 2023, respectively.
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v3.24.2.u1
PROPERTY AND EQUIPMENT
|
6 Months Ended |
Jun. 30, 2024 |
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, with all amounts converted into U.S. dollars:
SCHEDULE OF PROPERTY PLANT AND EQUIPMENT NET OF ACCUMULATED DEPRECIATION
| |
June
30, 2024 | | |
December
31, 2023 | |
Lab equipment | |
$ | 808,523 | | |
$ | 836,709 | |
Computer equipment and leasehold improvements | |
| 27,422 | | |
| 28,379 | |
Property and equipment, gross | |
| 27,422 | | |
| 28,379 | |
Less: Accumulated depreciation | |
| (430,831 | ) | |
| (357,711 | ) |
Property
and equipment, net of accumulated depreciation | |
$ | 405,114 | | |
$ | 507,377 | |
Depreciation
expense was $42,591 and $44,331 for the three months ended June 30, 2024 and 2023, respectively and $85,812 and $88,629 for the six months
ended June 30, 2024 and 2023, respectively.
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
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v3.24.2.u1
ACCRUED LIABILITIES
|
6 Months Ended |
Jun. 30, 2024 |
Payables and Accruals [Abstract] |
|
ACCRUED LIABILITIES |
NOTE
6. ACCRUED LIABILITIES
As
of June 30, 2024 and December 31, 2023, the accrued liabilities of the Company consisted of the following:
SCHEDULE OF ACCRUED LIABILITIES
| |
June
30, 2024 | | |
December
31, 2023 | |
Product development | |
$ | 79,197 | | |
$ | 139,981 | |
Accrued salaries, wages, and bonuses | |
| 8,634 | | |
| 8,889 | |
Professional fees | |
| 70,542 | | |
| 584,810 | |
Accrued restructuring costs (see Note 8) | |
| — | | |
| 301,645 | |
Accrued income taxes | |
| — | | |
| 22,318 | |
Patent costs | |
| 18,000 | | |
| 18,000 | |
Total
accrued expenses | |
$ | 176,373 | | |
$ | 1,075,643 | |
|
X |
- DefinitionThe entire disclosure for accounts payable and accrued liabilities at the end of the reporting period.
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v3.24.2.u1
SHARE CAPITAL AND OTHER EQUITY INSTRUMENTS
|
6 Months Ended |
Jun. 30, 2024 |
Equity [Abstract] |
|
SHARE CAPITAL AND OTHER EQUITY INSTRUMENTS |
NOTE
7. SHARE CAPITAL AND OTHER EQUITY INSTRUMENTS
Equity
Distribution Agreement
On
September 1, 2023, the Company entered into the Equity Distribution Agreement (the “Distribution Agreement”), with Canaccord
Genuity LLC (“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 six months ended June 30, 2024, the Company issued 1,668,000 shares of common stock for gross proceeds of $2,392,502 under the Distribution
Agreement, and charged offering costs of $583,713 to additional paid in capital on the unaudited condensed consolidated balance sheet.
As of June 30, 2024 and December 31, 2023, there were deferred offering costs related to the Distribution Agreement of $0 and $171,944,
respectively. As of June 30, 2024, there is $0 available under the Distribution Agreement.
On
December 28, 2023, the Company entered into warrant exercise inducement offer letters (the “Inducement Letters”) with certain
holders (the “Holders”) of the February 2022 Post-Modification Warrants and RD and PIPE preferred investment options to purchase
shares of the Company’s common stock (the “Existing Warrants and Investment Options”) pursuant to which the Holders
agreed to exercise for cash their Existing Warrants and Investment Options to purchase 1,122,000 shares of the Company’s common
stock, in the aggregate, at a reduced exercised price of $1.37 per share (from an original exercise price of $7.78 per share), in exchange
for the Company’s agreement to issue new warrants (the “Inducement Warrants”) to purchase up to 2,244,000 shares of
the Company’s common stock (the “Inducement Warrant Shares”), and the Holders to make a cash payment of $0.125 per
Inducement Warrant share for total proceeds of $280,500. In January 2024, the Company received aggregate gross proceeds of $1,817,640
from the exercise of the Existing Warrants and Investment Options by the Holders and the sale of the Inducement Warrants. Because the
Existing Warrants and Investment Options by the Holders and the sale of the Inducement Warrants that exercised on December 28, 2023 and
unsettled until January 2024, the proceeds are included in the condensed consolidated balance sheet as a subscription receivable as of
December 31, 2023. As of December 31, 2023, 418,000 shares of the Existing Warrants and Investment Options exercised were considered
issued as the Company had the enforceable right to the obtain the cash proceeds, which were in-transit, and the Holders were no longer
able to rescind the exercise election. Due to the beneficial ownership limitation provisions, 704,000 shares of the Existing Warrants
and Investment Options exercised were initially unissued and held in abeyance for the benefit of the Holder until notice is received
from the Holder that the shares may be issued in compliance with such limitation. During the six months ended June 30, 2024, the Company
issued all 704,000 shares of common stock of the 704,000 shares of Existing Warrants and Investment Options exercised that were held
in abeyance due to the beneficial ownership limitation provisions.
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
On
December 28, 2023, the Company entered into warrant exercise inducement offer letters (the “Inducement Letters”) with certain
holders of warrants and preferred investment options. The Inducement Letters prohibit the Company from entering into any variable rate
transaction as defined in the Inducement Letters, including the issuance of (1) any variable priced debt or equity securities or (2)
transactions whereby the Company may issue securities at a future determined price, such as through an at-the-market offering or an equity
line of credit. The variable rate transaction restriction would have expired after six-months from the closing date of December 28, 2023
for the Inducement Letters for an issuance through an at-the-market offering, and one-year for the remaining variable rate transactions,
however the restriction was waived for the at-the-market offering on March 8, 2024 and the equity line on May 3, 2024.
On
March 8, 2024, the Company entered into a series of common stock purchase agreements for the issuance in a registered direct offering
of 228,690 shares of the Company’s common stock to the Holders of the Inducement Warrants. The issuance was made in exchange for
the permanent and irrevocable waiver of the variable rate transaction limitation solely with respect to the entry into and/or issuance
of shares of common stock in an at the market offering contained in the Inducement Letters. The fair value of the shares issued for consideration
of waiving the variable rate transaction limitation was $322,453 and was charged to additional paid in capital, as it is direct and incremental to the Distribution Agreement, on the unaudited condensed
consolidated balance sheet as an offering cost related to the Distribution Agreement.
Lincoln
Park Equity Line
On
November 3, 2023, the Company entered into a Purchase Agreement (the “Purchase Agreement”) and a registration rights agreement
(the “Registration Rights Agreement”), with Lincoln Park Capital Fund, LLC (“Lincoln Park”), pursuant to which
Lincoln Park has committed to purchase up to $10.0 million of the Company’s common stock 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 the Company’s
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 the Company may elect to sell to Lincoln
Park under the Purchase Agreement, if any, will fluctuate based on the market prices of the Company’s Common Stock at the time
the Company elects 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 the Company 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 the Company
will receive from those purchases by Lincoln Park under the Purchase Agreement.
On
May 3, 2024, the Company entered into a series of common stock purchase agreements for the issuance in a registered direct offering of
an aggregate of 458,000 shares of the Company’s common stock, to certain institutional investors. The issuance was made in exchange
for the permanent and irrevocable waiver of the variable rate transaction limitation with respect to any existing or future agreement
by the Company to effect any issuance of shares and issue such shares thereunder, as contained in those certain Inducement Offer Letters,
dated December 28, 2023, between the Company and those certain institutional investors. The Company will not receive any net proceeds
in connection with the offering. The fair value of the shares issued for consideration of waiving the variable rate transaction limitation
was $448,840 and was recorded as deferred offering costs, as direct and incremental to the Purchase Agreement, within prepaid expenses and other current assets on the unaudited condensed
consolidated balance sheet related to the Purchase Agreement.
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
The
common stock purchase agreements contain customary representations and warranties and certain indemnification obligations of the Company.
The common stock purchase agreements also restrict the Company from issuing, entering into any agreement to issue, or announcing the
issuance of the Company’s common stock from the date of the common stock purchase agreements until the earlier of 30 days after
entering into the agreements or at such time as fifteen million (15,000,000) shares of the Company’s common stock have traded in
the open market. The closing of the issuance of the Shares pursuant to the common stock purchase agreements closed on May 3, 2024.
During
the three and six months ended June 30, 2024, the Company had issued 125,000 shares of common stock through the Purchase Agreement for
gross cash proceeds of $82,850 and the Company charged offering costs of $82,850 to additional paid in capital on the unaudited condensed
consolidated balance sheet. As of June 30, 2024 and December 31, 2023, the Company has capitalized deferred offering costs of $763,173
and $395,660, respectively. See Note 9 for shares issued after June 30, 2024.
Stock
Options
Amendment
to 2020 Long-Term Incentive Plan
On
November 2, 2023, the stockholders 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 (i) increased the number of authorized shares reserved
for issuance under the Amended Incentive Plan to a maximum of 350,000, subject to adjustment, and (ii) removed the Evergreen Provision
implemented in the Plan Amendment. During the first quarter of 2024, the Board approved an equitable adjustment to increase the number
of shares available under the Plan by 134,779 shares. As of June 30, 2024, the total number of shares available for grant under the Incentive
Plan was 6,257.
A
summary of the stock option activity under the Company’s incentive plan for the six months ended June 30, 2024 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,
2023 | |
| 30,329 | | |
$ | 57.17 | | |
$ | 77.22 | | |
| 3.4 | | |
$ | — | |
Granted | |
| — | | |
$ | — | | |
$ | — | | |
| | | |
| — | |
Forfeited | |
| (7,247 | ) | |
$ | 39.35 | | |
$ | 54.02 | | |
| | | |
| — | |
Outstanding at June 30, 2024 | |
| 23,082 | | |
$ | 62.77 | | |
$ | 84.51 | | |
| 2.9 | | |
$ | — | |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Exercisable at June 30, 2024 | |
| 21,988 | | |
$ | 65.74 | | |
$ | 88.59 | | |
| 2.5 | | |
$ | — | |
The
Company’s stock based compensation expense, recorded within general and administrative expense in the unaudited condensed consolidated
statement of operations and comprehensive loss, related to stock options for the three months ended June 30, 2024 and 2023 was $414 and
$54,375, respectively.
The
Company’s stock-based compensation expense, recorded within general and administrative expense, related to stock options for the
six months ended June 30, 2024 and 2023 was $(6,268) and $102,461, respectively.
As
of June 30, 2024, the Company had $2,760 in unamortized stock option expense, which will be recognized over a weighted average period
of 1.65 years.
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Issuance
of Restricted Stock Units
The
Company’s activity in restricted stock units was as follows for the six months ended June 30, 2024:
SCHEDULE OF RESTRICTED STOCK UNITS AND AWARDS ACTIVITY
| |
Number
of shares | | |
Weighted
average fair value | |
Non-vested at December 31, 2023 | |
| 140,491 | | |
$ | 28.97 | |
Granted | |
| 251,500 | | |
$ | 0.85 | |
Forfeited | |
| (9,750 | ) | |
$ | 2.87 | |
Vested | |
| (26,125 | ) | |
$ | 2.62 | |
Non-vested at June 30, 2024 | |
| 356,116 | | |
$ | 11.76 | |
For
the three months ended June 30, 2024 and 2023, the Company recorded $369,200 and $825,363, respectively, in stock-based compensation
expense related to restricted stock units, which is a component of both general and administrative and research and development expenses
in the unaudited condensed consolidated statement of operations and comprehensive loss. For the six months ended June 30, 2024 and 2023,
the Company recorded $727,370 and $1,310,112, respectively, in stock-based compensation expense related to restricted stock units, which
is a component of both general and administrative and research and development expenses in the condensed consolidated statement of operations
and comprehensive loss. As of June 30, 2024, the Company had unamortized stock-based compensation costs related to restricted stock units
of $1,478,726 which will be recognized over a weighted average period of 1.71 years. As of June 30, 2024, 41,901 restricted stock units
are vested without shares of common stock being issued, with all of these shares due as of June 30, 2024.
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
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three
Months Ended June 30, | | |
Six
Months Ended June 30, | |
Stock-based compensation expense for RSUs: | |
2024 | | |
2023 | | |
2024 | | |
2023 | |
General and administrative | |
$ | 162,042 | | |
$ | 592,929 | | |
$ | 314,471 | | |
$ | 845,244 | |
Research and development | |
| 207,158 | | |
| 232,434 | | |
| 412,899 | | |
| 464,868 | |
Total | |
$ | 369,200 | | |
$ | 825,363 | | |
$ | 727,370 | | |
$ | 1,310,112 | |
Stock-based compensation
expense for RSUs | |
$ | 369,200 | | |
$ | 825,363 | | |
$ | 727,370 | | |
$ | 1,310,112 | |
Warrants
and Preferred Investment Options
The
following table summarizes information about shares issuable under warrants outstanding at June 30, 2024:
SCHEDULE OF WARRANTS OUTSTANDING
| |
Warrant
shares outstanding | | |
Weighted
average exercise price | | |
Weighted
average remaining life | | |
Intrinsic
value | |
Outstanding at December 31,
2023 | |
| 2,799,213 | | |
$ | 11.79 | | |
| 4.6 | | |
$ | — | |
Exercised | |
| (1,954,000 | ) | |
| 1.37 | | |
| — | | |
$ | — | |
Outstanding at June 30, 2024 | |
| 845,213 | | |
$ | 35.87 | | |
| 3.2 | | |
$ | — | |
| |
| | | |
| | | |
| | | |
| | |
Exercisable at June 30, 2024 | |
| 845,213 | | |
$ | 35.87 | | |
| 3.2 | | |
$ | — | |
The
following table summarizes information about investment options outstanding at June 30, 2024:
SCHEDULE OF WARRANTS AND INVESTMENT OPTIONS
| |
Investment
options outstanding | | |
Weighted
average exercise price | | |
Weighted
average remaining life | | |
Intrinsic
value | |
Outstanding at December 31,
2023 | |
| 70,000 | | |
$ | 10.00 | | |
| 4.1 | | |
$ | — | |
Outstanding at June 30, 2024 | |
| 70,000 | | |
$ | 10.00 | | |
| 3.1 | | |
$ | — | |
| |
| | | |
| | | |
| | | |
| | |
Exercisable at June 30, 2024 | |
| 70,000 | | |
$ | 10.00 | | |
| 3.1 | | |
$ | — | |
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
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v3.24.2.u1
COMMITMENTS AND CONTINGENCIES
|
6 Months Ended |
Jun. 30, 2024 |
Commitments and Contingencies Disclosure [Abstract] |
|
COMMITMENTS AND CONTINGENCIES |
NOTE
8. 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-002, 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-002 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-002. EB-002, a next-generation proprietary psilocin prodrug, has been recognized as a
New Chemical Entity (NCE) by Australia’s Therapeutic Goods Administration and is currently in preclinical development
targeting the treatment of anxiety disorder. The total cost of the Avance Clinical contract is approximately 3,400,000
AUD, which translates to approximately $2,225,000
USD as of June 30, 2024. As of June 30, 2024, the Company has paid approximately $2,225,000
of the Avance Clinical contract costs and has $251,254
recorded as prepaid assets within prepaid and other current assets, accrued $— recorded as accrued liabilities and $— as
accounts payable on the accompanying condensed consolidated balance sheet. For the three and six months ended June 30, 2024 and
2023, the Company has expensed $(154,354)
and $244,390,
and $354,419
and $355,232,
respectively, in research and development expenses within the accompanying unaudited condensed consolidated statement of operations.
As of June 30, 2024, all payments have been made and the project is substantially completed.
According
to Australian tax law, the Company is allowed an R&D tax credit that reduces a company’s tax bill in Australia for expenses
incurred in R&D subject to certain requirements. The Company’s Australian subsidiary submits R&D tax credit requests annually
for research and development expenses incurred. At June 30, 2024 and December 31, 2023, the Company had a research and development tax
credit receivable of $261,058 and $145,349, respectively, for R&D expenses incurred in Australia, included in prepaid and other current
assets within the accompanying unaudited condensed consolidated statement of operations.
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 patent portfolio acquired and developed under the Vogel-Nathan Purchase Agreement
was sold to undisclosed buyers for an undisclosed sum in the first quarter of 2024. No additional financial or other obligations exist
regarding the Vogel-Nathan Purchase Agreement.
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 one and 12 months. These agreements, in aggregate, commit the Company to approximately $0.1 million in future
cash payments, inclusive of amounts in accounts payable.
Reduction
in Force/Restructuring
In
May 2023, the Company entered into a cost reduction plan, including a reduction in force (“RIF”) 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 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.
In
June 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 received salary
and benefits that is paid out in twelve monthly installments beginning in July 2023, was eligible for his 2023 performance bonus, which
was not achieved, and any outstanding restricted stock units retained their vesting conditions.
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
The
following table summarizes the Reduction in Force/Restructuring activity and ending balance at June 30, 2024 for the remaining severance
payments included in accrued expenses in the consolidated balance sheet:
SCHEDULE OF REDUCTION IN FORCE/RESTRUCTURING ACTIVITY
| |
Accrued
Restructuring Costs | |
January 1, 2024 beginning balance | |
$ | 301,645 | |
Restructuring costs
paid | |
| (301,645 | ) |
June 30, 2024 ending balance | |
$ | — | |
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v3.24.2.u1
SUBSEQUENT EVENTS
|
6 Months Ended |
Jun. 30, 2024 |
Subsequent Events [Abstract] |
|
SUBSEQUENT EVENTS |
NOTE
9. SUBSEQUENT EVENTS
Subsequent
to June 30, 2024, the Company issued 1,015,477
shares of common stock through the Purchase Agreement
with Lincoln Park for gross cash proceeds of $494,887. As of July 30, 2024, there were no remaining shares available to be issued in
connection with this agreement.
On
July 10, 2024, Akos entered into an Exclusive License Agreement (the “License Agreement”) with Aries Science and Technology,
LLC, an Ohio limited liability company (“Aries”), pursuant to which Akos granted Aries a license of Akos’s patented
radiation dermatitis topical product. The license allows Akos to use the patented formulation to develop pharmaceutical or non-pharmaceutical
products for treating radiation dermatitis suitable for administration to humans or animals. The license is exclusive (subject to certain
exceptions contained in the License Agreement), worldwide, royalty-bearing, and includes the right to sublicense. Akos is entitled to
potential license payments, milestone payments and royalties based on net revenues of the Licensed Product on a licensed product-by-licensed
product and country-by-country basis pursuant to the terms of the Agreement. Aries has the option during the license term, to purchase
the rights to each licensed product (on a licensed product-by-licensed product basis) in the form of an exclusive (as to the applicable
licensed product), fully paid, transferable right and license to the licensed product.
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v3.24.2.u1
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)
|
6 Months Ended |
Jun. 30, 2024 |
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 six months ended June 30, 2024 are not necessarily indicative of the results that may be expected for the year ending
December 31, 2024. These unaudited condensed consolidated financial statements should be read in conjunction with the consolidated financial
statements for the year ended December 31, 2023, 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 26, 2024.
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
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, 2023. There were no significant changes to these accounting policies during the
three and six months ended June 30, 2024.
|
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, the
valuation of warrants and preferred investment options, and the valuation of stock-based compensation and accruals associated with
third party providers supporting research and development efforts. Actual results could differ from those estimates.
|
Reclassification |
Reclassification
Certain
reclassifications have been made to the prior period’s unaudited condensed consolidated financial statements in order to conform
to the current year presentation. In the prior year, the Company included certain investor related expenses were included within research
and development on the unaudited condensed consolidated statements of operations. These expenses were reclassified to general and administrative
expenses in the current year. This reclassification had no effect on the Company’s previously reported results of operations, changes
in equity, or cash flows.
|
Foreign Currency Translation |
Foreign
Currency Translation
From
inception through June 30, 2024, 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 June 30, 2024
and 2023, 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 unaudited condensed consolidated statements of shareholders’ equity as a component of accumulated other comprehensive loss.
The
Company has not entered into any financial derivative instruments that expose it to material market risk, including any instruments designed
to hedge the impact of foreign currency exposures. The Company may, however, hedge such exposure to foreign currency exchange fluctuations
in the future.
Adjustments
that arise from exchange rate changes on transactions denominated in a currency other than the local currency are included in other comprehensive
loss in the unaudited 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 June 30, 2024, the Company had greater than $250,000 at United States financial institutions, less than $250,000
at Australian financial institutions, and less than $100,000 at Canadian financial institutions.
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
|
Research and Development |
Research
and Development
Research
and development expenses are charged to operations as incurred. Research and development expenses include, among other things, internal
and external costs associated with preclinical development, pre-commercialization manufacturing expenses, and clinical trials. The Company
accrues for costs incurred as the services are being provided by monitoring the status of the trial or services provided and the invoices
received from its external service providers. In the case of clinical trials, a portion of the estimated cost normally relates to the
projected cost to treat a patient in the trials, and this cost is recognized based on the number of patients enrolled in the trial. As
actual costs become known, the Company adjusts its accruals accordingly.
|
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.
|
Research and Development Tax Incentive Receivable |
Research
and Development Tax Incentive Receivable
The
Company, through its wholly-owned subsidiary in Australia, participates in the Australian research and development tax incentive program,
such that a percentage of the Company’s qualifying research and development expenditures are reimbursed by the Australian government,
and such incentives are reflected as a reduction of research and development expense. The Australian research and development tax incentive
is recognized when there is reasonable assurance that the incentive will be received, the relevant expenditure has been incurred and
the amount of the consideration can be reliably measured. At each period end, management estimates the reimbursement available to the
Company based on available information at the time.
|
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 six months ended June 30, 2024 and 2023
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 for the three and
six months ended June 30, 2024 and 2023 because the effect of their inclusion would have been anti-dilutive.
SCHEDULE OF POTENTIALLY DILUTIVE SECURITIES
| |
For
the three and six months ended June 30, 2024 | | |
For
the three and six months ended June 30, 2023 | |
Warrants to purchase shares of
common stock | |
| 845,213 | | |
| 655,463 | |
Restricted stock units - vested and unissued | |
| 41,901 | | |
| 55,622 | |
Restricted stock units - unvested | |
| 356,116 | | |
| 180,115 | |
Restricted stock awards - vested and unissued | |
| — | | |
| 708 | |
Investment options to purchase shares of common
stock | |
| 70,000 | | |
| 1,070,000 | |
Options to purchase
shares of common stock | |
| 23,082 | | |
| 36,579 | |
Total potentially dilutive
securities | |
| 1,336,312 | | |
| 1,998,487 | |
|
Recent Accounting Pronouncements |
Recent
Accounting Pronouncements
In
November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. ASU
2023-07 updates reportable segment disclosure requirements primarily through enhanced disclosures about significant segment expenses.
ASU 2023-07 is effective for all entities for fiscal years beginning after December 15, 2023, and for interim periods within fiscal years
beginning after December 15, 2024. Early adoption is permitted. The amendments should be applied retrospectively to all prior periods
presented in the financial statements. The Company is currently assessing the potential impacts of ASU 2023-07, however as the Company
currently has one reportable segment, does not expect this guidance will not have a material impact on its unaudited
condensed consolidated financial statements.
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
In
December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which amends the
disclosure to address investor requests for more transparency about income tax information through improvements to income tax disclosures
primarily related to the rate reconciliation and income taxes paid information and includes certain other amendments to improve the effectiveness
of income tax disclosures. The ASU is effective on a prospective basis for annual periods beginning after December 15, 2024, and early
adoption and retrospective application are permitted. Early adoption is permitted. The Company is currently assessing potential impacts
of ASU 2023-09 and does not expect the adoption of this guidance will have a material impact on its unaudited condensed consolidated
financial statements and disclosures.
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v3.24.2.u1
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Accounting Policies [Abstract] |
|
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 for the three and
six months ended June 30, 2024 and 2023 because the effect of their inclusion would have been anti-dilutive.
SCHEDULE OF POTENTIALLY DILUTIVE SECURITIES
| |
For
the three and six months ended June 30, 2024 | | |
For
the three and six months ended June 30, 2023 | |
Warrants to purchase shares of
common stock | |
| 845,213 | | |
| 655,463 | |
Restricted stock units - vested and unissued | |
| 41,901 | | |
| 55,622 | |
Restricted stock units - unvested | |
| 356,116 | | |
| 180,115 | |
Restricted stock awards - vested and unissued | |
| — | | |
| 708 | |
Investment options to purchase shares of common
stock | |
| 70,000 | | |
| 1,070,000 | |
Options to purchase
shares of common stock | |
| 23,082 | | |
| 36,579 | |
Total potentially dilutive
securities | |
| 1,336,312 | | |
| 1,998,487 | |
|
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v3.24.2.u1
PREPAID EXPENSES AND OTHER CURRENT ASSETS (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] |
|
SCHEDULE OF PREPAID EXPENSES AND OTHER CURRENT ASSETS |
As
of June 30, 2024 and December 31, 2023, the prepaid expenses and other current assets of the Company consisted of the following:
SCHEDULE OF PREPAID EXPENSES AND OTHER CURRENT ASSETS
| |
June
30, 2024 | | |
December
31, 2023 | |
Prepaid research and development | |
$ | 257,218 | | |
$ | 46,320 | |
Prepaid value-added taxes | |
| 241,269 | | |
| 243,429 | |
Prepaid insurance | |
| 375,215 | | |
| 149,559 | |
Prepaid other | |
| 81,192 | | |
| 62,036 | |
Deferred offering costs (see Note 7) | |
| 763,173 | | |
| 567,603 | |
Franchise tax receivable | |
| 38,258 | | |
| 79,258 | |
R&D tax incentive
receivable | |
| 261,058 | | |
| 145,349 | |
Total
prepaid expenses and other current assets | |
$ | 2,017,383 | | |
$ | 1,293,554 | |
|
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v3.24.2.u1
PROPERTY AND EQUIPMENT (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
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, with all amounts converted into U.S. dollars:
SCHEDULE OF PROPERTY PLANT AND EQUIPMENT NET OF ACCUMULATED DEPRECIATION
| |
June
30, 2024 | | |
December
31, 2023 | |
Lab equipment | |
$ | 808,523 | | |
$ | 836,709 | |
Computer equipment and leasehold improvements | |
| 27,422 | | |
| 28,379 | |
Property and equipment, gross | |
| 27,422 | | |
| 28,379 | |
Less: Accumulated depreciation | |
| (430,831 | ) | |
| (357,711 | ) |
Property
and equipment, net of accumulated depreciation | |
$ | 405,114 | | |
$ | 507,377 | |
|
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v3.24.2.u1
ACCRUED LIABILITIES (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Payables and Accruals [Abstract] |
|
SCHEDULE OF ACCRUED LIABILITIES |
As
of June 30, 2024 and December 31, 2023, the accrued liabilities of the Company consisted of the following:
SCHEDULE OF ACCRUED LIABILITIES
| |
June
30, 2024 | | |
December
31, 2023 | |
Product development | |
$ | 79,197 | | |
$ | 139,981 | |
Accrued salaries, wages, and bonuses | |
| 8,634 | | |
| 8,889 | |
Professional fees | |
| 70,542 | | |
| 584,810 | |
Accrued restructuring costs (see Note 8) | |
| — | | |
| 301,645 | |
Accrued income taxes | |
| — | | |
| 22,318 | |
Patent costs | |
| 18,000 | | |
| 18,000 | |
Total
accrued expenses | |
$ | 176,373 | | |
$ | 1,075,643 | |
|
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v3.24.2.u1
SHARE CAPITAL AND OTHER EQUITY INSTRUMENTS (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Equity [Abstract] |
|
SCHEDULE OF STOCK OPTION |
A
summary of the stock option activity under the Company’s incentive plan for the six months ended June 30, 2024 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,
2023 | |
| 30,329 | | |
$ | 57.17 | | |
$ | 77.22 | | |
| 3.4 | | |
$ | — | |
Granted | |
| — | | |
$ | — | | |
$ | — | | |
| | | |
| — | |
Forfeited | |
| (7,247 | ) | |
$ | 39.35 | | |
$ | 54.02 | | |
| | | |
| — | |
Outstanding at June 30, 2024 | |
| 23,082 | | |
$ | 62.77 | | |
$ | 84.51 | | |
| 2.9 | | |
$ | — | |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Exercisable at June 30, 2024 | |
| 21,988 | | |
$ | 65.74 | | |
$ | 88.59 | | |
| 2.5 | | |
$ | — | |
|
SCHEDULE OF RESTRICTED STOCK UNITS AND AWARDS ACTIVITY |
The
Company’s activity in restricted stock units was as follows for the six months ended June 30, 2024:
SCHEDULE OF RESTRICTED STOCK UNITS AND AWARDS ACTIVITY
| |
Number
of shares | | |
Weighted
average fair value | |
Non-vested at December 31, 2023 | |
| 140,491 | | |
$ | 28.97 | |
Granted | |
| 251,500 | | |
$ | 0.85 | |
Forfeited | |
| (9,750 | ) | |
$ | 2.87 | |
Vested | |
| (26,125 | ) | |
$ | 2.62 | |
Non-vested at June 30, 2024 | |
| 356,116 | | |
$ | 11.76 | |
|
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
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three
Months Ended June 30, | | |
Six
Months Ended June 30, | |
Stock-based compensation expense for RSUs: | |
2024 | | |
2023 | | |
2024 | | |
2023 | |
General and administrative | |
$ | 162,042 | | |
$ | 592,929 | | |
$ | 314,471 | | |
$ | 845,244 | |
Research and development | |
| 207,158 | | |
| 232,434 | | |
| 412,899 | | |
| 464,868 | |
Total | |
$ | 369,200 | | |
$ | 825,363 | | |
$ | 727,370 | | |
$ | 1,310,112 | |
Stock-based compensation
expense for RSUs | |
$ | 369,200 | | |
$ | 825,363 | | |
$ | 727,370 | | |
$ | 1,310,112 | |
|
SCHEDULE OF WARRANTS OUTSTANDING |
The
following table summarizes information about shares issuable under warrants outstanding at June 30, 2024:
SCHEDULE OF WARRANTS OUTSTANDING
| |
Warrant
shares outstanding | | |
Weighted
average exercise price | | |
Weighted
average remaining life | | |
Intrinsic
value | |
Outstanding at December 31,
2023 | |
| 2,799,213 | | |
$ | 11.79 | | |
| 4.6 | | |
$ | — | |
Exercised | |
| (1,954,000 | ) | |
| 1.37 | | |
| — | | |
$ | — | |
Outstanding at June 30, 2024 | |
| 845,213 | | |
$ | 35.87 | | |
| 3.2 | | |
$ | — | |
| |
| | | |
| | | |
| | | |
| | |
Exercisable at June 30, 2024 | |
| 845,213 | | |
$ | 35.87 | | |
| 3.2 | | |
$ | — | |
|
SCHEDULE OF WARRANTS AND INVESTMENT OPTIONS |
The
following table summarizes information about investment options outstanding at June 30, 2024:
SCHEDULE OF WARRANTS AND INVESTMENT OPTIONS
| |
Investment
options outstanding | | |
Weighted
average exercise price | | |
Weighted
average remaining life | | |
Intrinsic
value | |
Outstanding at December 31,
2023 | |
| 70,000 | | |
$ | 10.00 | | |
| 4.1 | | |
$ | — | |
Outstanding at June 30, 2024 | |
| 70,000 | | |
$ | 10.00 | | |
| 3.1 | | |
$ | — | |
| |
| | | |
| | | |
| | | |
| | |
Exercisable at June 30, 2024 | |
| 70,000 | | |
$ | 10.00 | | |
| 3.1 | | |
$ | — | |
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v3.24.2.u1
COMMITMENTS AND CONTINGENCIES (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Commitments and Contingencies Disclosure [Abstract] |
|
SCHEDULE OF REDUCTION IN FORCE/RESTRUCTURING ACTIVITY |
The
following table summarizes the Reduction in Force/Restructuring activity and ending balance at June 30, 2024 for the remaining severance
payments included in accrued expenses in the consolidated balance sheet:
SCHEDULE OF REDUCTION IN FORCE/RESTRUCTURING ACTIVITY
| |
Accrued
Restructuring Costs | |
January 1, 2024 beginning balance | |
$ | 301,645 | |
Restructuring costs
paid | |
| (301,645 | ) |
June 30, 2024 ending balance | |
$ | — | |
|
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v3.24.2.u1
BUSINESS AND LIQUIDITY AND OTHER UNCERTAINTIES (Details Narrative) - USD ($)
|
3 Months Ended |
6 Months Ended |
|
|
|
|
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
May 16, 2024 |
Dec. 31, 2023 |
Nov. 21, 2023 |
Nov. 12, 2023 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
|
|
|
|
|
|
|
Accumulated deficit |
$ (100,835,827)
|
|
$ (100,835,827)
|
|
|
$ (96,499,518)
|
|
|
Net cash used in operating activities |
|
|
(5,487,520)
|
$ (9,602,930)
|
|
|
|
|
Loss from operations |
(1,897,931)
|
$ (5,755,007)
|
(4,375,248)
|
$ (10,615,685)
|
|
|
|
|
Cash |
3,502,551
|
|
3,502,551
|
|
|
$ 2,287,977
|
|
|
Working capital |
$ 4,874,594
|
|
$ 4,874,594
|
|
|
|
|
|
Minimum of stockholders equity required for continued listing pursuant to exchange |
|
|
|
|
|
|
$ 2,500,000
|
|
Shares issued price |
|
|
|
|
$ 1.00
|
|
|
$ 1.00
|
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SCHEDULE OF POTENTIALLY DILUTIVE SECURITIES (Details) - shares
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
|
Total potentially dilutive securities |
1,336,312
|
1,998,487
|
1,336,312
|
1,998,487
|
Warrants to Purchase Shares of Common Stock [Member] |
|
|
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
|
Total potentially dilutive securities |
845,213
|
655,463
|
845,213
|
655,463
|
Restricted Stock Units Vested and Unissued [Member] |
|
|
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
|
Total potentially dilutive securities |
41,901
|
55,622
|
41,901
|
55,622
|
Restricted Stock Units Unvested [Member] |
|
|
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
|
Total potentially dilutive securities |
356,116
|
180,115
|
356,116
|
180,115
|
Restricted Stock Awards Vested and Unissued [Member] |
|
|
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
|
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|
708
|
|
708
|
Investment Options to Purchase Shares of Common Stock [Member] |
|
|
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
|
Total potentially dilutive securities |
70,000
|
1,070,000
|
70,000
|
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 |
23,082
|
36,579
|
23,082
|
36,579
|
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v3.24.2.u1
SCHEDULE OF PREPAID EXPENSES AND OTHER CURRENT ASSETS (Details) - USD ($)
|
Jun. 30, 2024 |
Dec. 31, 2023 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] |
|
|
Prepaid research and development |
$ 257,218
|
$ 46,320
|
Prepaid value-added taxes |
241,269
|
243,429
|
Prepaid insurance |
375,215
|
149,559
|
Prepaid other |
81,192
|
62,036
|
Deferred offering costs (see Note 7) |
763,173
|
567,603
|
Franchise tax receivable |
38,258
|
79,258
|
R&D tax incentive receivable |
261,058
|
145,349
|
Total prepaid expenses and other current assets |
$ 2,017,383
|
$ 1,293,554
|
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SCHEDULE OF INTANGIBLE ASSETS (Details) - USD ($)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Goodwill and Intangible Assets Disclosure [Abstract] |
|
|
|
|
Balance, Definite lived intangible assets |
|
|
$ 210,932
|
|
Amortization |
$ (42,188)
|
$ (42,187)
|
(84,376)
|
$ (84,375)
|
Balance, Definite lived intangible assets |
$ 126,556
|
|
$ 126,556
|
|
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INTANGIBLE ASSETS (Details Narrative) - USD ($)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Goodwill and Intangible Assets Disclosure [Abstract] |
|
|
|
|
Identified definite lived assets, impairment loss |
$ 0
|
$ 0
|
$ 0
|
$ 0
|
Intangible assets, amortization expense |
$ 42,188
|
$ 42,187
|
$ 84,376
|
$ 84,375
|
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SCHEDULE OF PROPERTY PLANT AND EQUIPMENT NET OF ACCUMULATED DEPRECIATION (Details) - USD ($)
|
Jun. 30, 2024 |
Dec. 31, 2023 |
Property, Plant and Equipment [Line Items] |
|
|
Less: Accumulated depreciation |
$ (430,831)
|
$ (357,711)
|
Property and equipment, net of accumulated depreciation |
405,114
|
507,377
|
Lab Equipment [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Property and equipment, gross |
808,523
|
836,709
|
Computer Equipment and Leasehold Improvements [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Property and equipment, gross |
$ 27,422
|
$ 28,379
|
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- 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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v3.24.2.u1
SCHEDULE OF ACCRUED LIABILITIES (Details) - USD ($)
|
Jun. 30, 2024 |
Dec. 31, 2023 |
Payables and Accruals [Abstract] |
|
|
Product development |
$ 79,197
|
$ 139,981
|
Accrued salaries, wages, and bonuses |
8,634
|
8,889
|
Professional fees |
70,542
|
584,810
|
Accrued restructuring costs (see Note 8) |
|
301,645
|
Accrued income taxes |
|
22,318
|
Patent costs |
18,000
|
18,000
|
Total accrued expenses |
$ 176,373
|
$ 1,075,643
|
X |
- DefinitionAccrued product and development cost
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v3.24.2.u1
SCHEDULE OF STOCK OPTION (Details) - USD ($)
|
6 Months Ended |
12 Months Ended |
Jun. 30, 2024 |
Dec. 31, 2023 |
Equity [Abstract] |
|
|
Number of shares, outstanding at beginning |
30,329
|
|
Weighted average exercise price, outstanding at beginning |
$ 57.17
|
|
Weighted average grant date fair value, outstanding at beginning |
$ 77.22
|
|
Weighted average remaining contractual term, outstanding balance |
2 years 10 months 24 days
|
3 years 4 months 24 days
|
Aggregate intrinsic value, outstanding at beginning |
|
|
Number of shares, granted |
|
|
Weighted average exercise price, granted |
|
|
Weighted average grant date fair value, granted |
|
|
Number of shares, forfeited |
(7,247)
|
|
Weighted average exercise price, forfeited |
$ 39.35
|
|
Weighted average grant date fair value, forfeited |
$ 54.02
|
|
Number of shares, outstanding at end |
23,082
|
30,329
|
Weighted average exercise price, outstanding at end |
$ 62.77
|
$ 57.17
|
Weighted average grant date fair value, outstanding at end |
$ 84.51
|
$ 77.22
|
Aggregate intrinsic value, outstanding at end |
|
|
Exercisable shares at end |
21,988
|
|
Exercisable weighted average price at end |
$ 65.74
|
|
Weighted average grant date fair value, exercisable |
$ 88.59
|
|
Weighted average remaining contractual term, exercisable |
2 years 6 months
|
|
Aggregate intrinsic value, exercisable |
|
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v3.24.2.u1
SCHEDULE OF RESTRICTED STOCK UNITS AND AWARDS ACTIVITY (Details) - Restricted Stock Units (RSUs) [Member]
|
6 Months Ended |
Jun. 30, 2024
$ / shares
shares
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Number of shares, Non-vested beginning | shares |
140,491
|
Weighted average fair value, Non-vested beginning | $ / shares |
$ 28.97
|
Number of shares, Granted | shares |
251,500
|
Weighted average fair value, Granted | $ / shares |
$ 0.85
|
Number of shares, Forfeited | shares |
(9,750)
|
Weighted average fair value, Forfeited | $ / shares |
$ 2.87
|
Number of shares, vested | shares |
(26,125)
|
Weighted average fair value, Vested | $ / shares |
$ 2.62
|
Number of shares, non-vested ending | shares |
356,116
|
Weighted average fair value, Non-vested ending | $ / shares |
$ 11.76
|
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- DefinitionThe number of equity-based payment instruments, excluding stock (or unit) options, that were forfeited during the reporting period.
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3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
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592,929
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314,471
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845,244
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SCHEDULE OF WARRANTS OUTSTANDING (Details) - Warrant [Member] - USD ($)
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12 Months Ended |
Jun. 30, 2024 |
Dec. 31, 2023 |
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|
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2,799,213
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$ 11.79
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3 years 2 months 12 days
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4 years 7 months 6 days
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|
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(1,954,000)
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$ 1.37
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845,213
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2,799,213
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$ 35.87
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$ 11.79
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|
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845,213
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$ 35.87
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6 Months Ended |
12 Months Ended |
Jun. 30, 2024 |
Dec. 31, 2023 |
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|
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70,000
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4 years 1 month 6 days
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|
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70,000
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70,000
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$ 10.00
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|
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70,000
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|
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$ 10.00
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3 years 1 month 6 days
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|
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v3.24.2.u1
SHARE CAPITAL AND OTHER EQUITY INSTRUMENTS (Details Narrative) - USD ($)
|
|
|
|
|
|
1 Months Ended |
3 Months Ended |
6 Months Ended |
12 Months Ended |
|
May 03, 2024 |
Mar. 08, 2024 |
Dec. 28, 2023 |
Nov. 03, 2023 |
Sep. 01, 2023 |
Jan. 31, 2024 |
Jun. 30, 2024 |
Mar. 31, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Dec. 31, 2023 |
Nov. 02, 2023 |
Class of Warrant or Right [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock, par value |
|
|
|
|
|
|
$ 0.01
|
|
|
$ 0.01
|
|
$ 0.01
|
|
Proceeds from common stock |
|
|
|
|
|
|
|
|
|
$ 2,290,186
|
|
|
|
Offering costs |
|
|
|
|
|
|
|
|
|
161,312
|
|
|
|
Offering costs |
|
|
|
|
|
|
$ 763,173
|
|
|
763,173
|
|
$ 567,603
|
|
Gross proceeds |
|
|
|
|
|
$ 1,817,640
|
|
|
|
2,676,980
|
|
|
|
Deferred offering costs |
|
|
|
|
|
|
82,850
|
$ 583,713
|
|
|
|
|
|
Stock based compensation expenses |
|
|
|
|
|
|
369,200
|
|
$ 825,363
|
727,370
|
1,310,112
|
|
|
Share-Based Payment Arrangement, Option [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of Warrant or Right [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock based compensation expenses |
|
|
|
|
|
|
414
|
|
54,375
|
6,268
|
102,461
|
|
|
Unamortized stock-based compensation costs |
|
|
|
|
|
|
2,760
|
|
|
$ 2,760
|
|
|
|
Weighted average period |
|
|
|
|
|
|
|
|
|
1 year 7 months 24 days
|
|
|
|
Restricted Stock Units (RSUs) [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of Warrant or Right [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock based compensation expenses |
|
|
|
|
|
|
369,200
|
|
$ 825,363
|
$ 727,370
|
$ 1,310,112
|
|
|
Unamortized stock-based compensation costs |
|
|
|
|
|
|
$ 1,478,726
|
|
|
$ 1,478,726
|
|
|
|
Weighted average period |
|
|
|
|
|
|
|
|
|
1 year 8 months 15 days
|
|
|
|
Common stock vested restricted stock units |
|
|
|
|
|
|
|
|
|
26,125
|
|
|
|
2020 Long Term Incentive Plan [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of Warrant or Right [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Authorized shares reserved |
|
|
|
|
|
|
|
|
|
|
|
|
350,000
|
2020 Long Term Incentive Plan [Member] | Board [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of Warrant or Right [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares available for grant |
|
|
|
|
|
|
6,257
|
134,779
|
|
6,257
|
|
|
|
Common Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of Warrant or Right [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock Issued During Period, Shares, Other |
|
|
|
|
|
|
|
704,000
|
|
|
|
418,000
|
|
Common Stock [Member] | Restricted Stock Units (RSUs) [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of Warrant or Right [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock vested restricted stock units |
|
|
|
|
|
|
|
|
|
41,901
|
|
|
|
February Warrants [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of Warrant or Right [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Issued shares |
|
|
1,122,000
|
|
|
|
|
|
|
|
|
|
|
Issued shares |
|
|
2,244,000
|
|
|
|
704,000
|
|
|
704,000
|
|
704,000
|
|
Cash payment |
|
|
$ 0.125
|
|
|
|
|
|
|
|
|
|
|
Proceeds from inducement warrant |
|
|
$ 280,500
|
|
|
|
|
|
|
|
|
|
|
February Warrants [Member] | Minimum [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of Warrant or Right [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Share price |
|
|
$ 1.37
|
|
|
|
|
|
|
|
|
|
|
February Warrants [Member] | Maximum [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of Warrant or Right [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Share price |
|
|
|
|
|
|
|
|
|
|
|
$ 7.78
|
|
Distribution Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of Warrant or Right [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Offering costs |
|
|
|
|
|
|
$ 0
|
|
|
$ 0
|
|
|
|
Distribution Agreement [Member] | Canaccord Genuity LLC [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of Warrant or Right [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%
|
|
|
|
|
|
|
|
|
Issued shares |
|
|
|
|
|
|
|
|
|
1,668,000
|
|
|
|
Proceeds from common stock |
|
|
|
|
|
|
|
|
|
$ 2,392,502
|
|
|
|
Offering costs |
|
|
|
|
|
|
|
|
|
583,713
|
|
|
|
Offering costs |
|
|
|
|
|
|
$ 0
|
|
|
$ 0
|
|
$ 171,944
|
|
Purchase Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of Warrant or Right [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Issued shares |
458,000
|
228,690
|
|
|
|
|
|
|
|
|
|
|
|
Issued stock value |
$ 448,840
|
$ 322,453
|
|
|
|
|
|
|
|
|
|
|
|
Registration Rights Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of Warrant or Right [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchase committment |
|
|
|
$ 10,000,000.0
|
|
|
|
|
|
|
|
|
|
Purchase Agreements [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of Warrant or Right [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Issued shares |
|
|
|
|
|
|
125,000
|
|
|
125,000
|
|
|
|
Proceeds from common stock |
|
|
|
|
|
|
$ 82,850
|
|
|
$ 82,850
|
|
|
|
Offering costs |
|
|
|
|
|
|
$ 763,173
|
|
|
763,173
|
|
$ 395,660
|
|
Number of shares traded in market |
15,000,000
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred offering costs |
|
|
|
|
|
|
|
|
|
$ 82,850
|
|
|
|
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COMMITMENTS AND CONTINGENCIES (Details Narrative)
|
|
3 Months Ended |
6 Months Ended |
|
|
May 31, 2023 |
Jun. 30, 2024
USD ($)
|
Jun. 30, 2023
USD ($)
|
Jun. 30, 2024
USD ($)
|
Jun. 30, 2023
USD ($)
|
Jun. 30, 2024
AUD ($)
|
Dec. 31, 2023
USD ($)
|
Property, Plant and Equipment [Line Items] |
|
|
|
|
|
|
|
Research and development expenses |
|
$ 515,501
|
$ 2,395,589
|
$ 973,656
|
$ 4,249,981
|
|
|
Research and development expense tax credit receivable |
|
261,058
|
|
261,058
|
|
|
$ 145,349
|
Future cash |
|
3,502,551
|
|
3,502,551
|
|
|
$ 2,287,977
|
Reduction in force restructuring percentage |
35.00%
|
|
|
|
|
|
|
Other Consulting and Vendor Agreements [Member] |
|
|
|
|
|
|
|
Property, Plant and Equipment [Line Items] |
|
|
|
|
|
|
|
Future cash |
|
100,000
|
|
100,000
|
|
|
|
Avance Clinical [Member] |
|
|
|
|
|
|
|
Property, Plant and Equipment [Line Items] |
|
|
|
|
|
|
|
Contract cost |
|
2,225,000
|
|
2,225,000
|
|
$ 3,400,000
|
|
Payment of contract cost |
|
2,225,000
|
|
2,225,000
|
|
|
|
Prepaid assets |
|
251,254
|
|
251,254
|
|
|
|
Research and development expenses |
|
$ 154,354
|
$ 354,419
|
$ 244,390
|
$ 355,232
|
|
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