UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
☒
Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
For
the quarterly period ended: March 31, 2025
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
Securities
registered pursuant to Section 12(g) of the Act: None
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
the 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 May 14, 2025, the Registrant had 2,471,656 shares
of Common Stock (par value $0.01 per share) outstanding.
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
FORM
10-Q
TABLE
OF CONTENTS
Page
PART
I - FINANCIAL INFORMATION
Item
1.
Financial
Statements
Condensed Consolidated Balance Sheets as of March 31, 2025 (Unaudited) and December 31, 2024
2
Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss for the three months ended March 31, 2025 and 2024
3
Unaudited Condensed Consolidated Statements of Changes in Shareholders’ Equity for the three months ended March 31, 2025 and 2024
4
Unaudited Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2025 and 2024
6
Notes to Unaudited Condensed Consolidated Financial Statements
7
Item
2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
14
Item
3.
Quantitative and Qualitative Disclosures About Market Risk
19
Item
4.
Controls and Procedures
19
PART II - OTHER INFORMATION
Item
1.
Legal Proceedings
20
Item
1A.
Risk Factors
20
Item
2.
Unregistered Sales of Equity Securities and Use of Proceeds
20
Item
3.
Defaults Upon Senior Securities
20
Item
4.
Mine Safety Disclosures
20
Item
5.
Other Information
20
Item
6.
Exhibits
20
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED BALANCE SHEETS
March 31, 2025
December 31, 2024
(Unaudited)
ASSETS
Current assets:
Cash
$ 4,294,435
$ 2,241,026
Prepaid expenses and other current assets
540,405
493,558
Total current assets
4,834,840
2,734,584
Other assets:
Property and equipment, net
267,279
305,777
Intangible assets, net
—
42,182
Total other assets
267,279
347,959
Total assets
$ 5,102,119
$ 3,082,543
LIABILITIES, MEZZANINE EQUITY, AND SHAREHOLDERS’ EQUITY
Current liabilities:
Accounts payable
$ 669,194
$ 521,747
Due to related parties
101,375
232,891
Accrued expenses and other current liabilities
413,837
735,098
Total current liabilities
1,184,406
1,489,736
Commitments and contingencies (Note 9)
-
-
Mezzanine equity
Series C redeemable preferred stock, $ 0.01 par value, 100,000 shares authorized, and 0 shares issued and outstanding as of March 31, 2025 and December 31, 2024, respectively
—
—
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 March 31, 2025 and December 31, 2024, respectively
—
—
Common stock, $ 0.01 par value, 100,000,000 shares authorized, 2,471,656 and 678,002 shares issued and outstanding as of March 31, 2025 and December 31, 2024, respectively
24,716
6,780
Additional paid-in capital
112,750,472
108,255,049
Accumulated deficit
( 108,259,471 )
( 106,074,505 )
Accumulated other comprehensive loss
( 598,004 )
( 594,517 )
Total shareholders’ equity
3,917,713
1,592,807
Total liabilities, mezzanine equity, and shareholders’ equity
$ 5,102,119
$ 3,082,543
See
the accompanying notes to the unaudited condensed consolidated financial statements.
2
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
UNAUDITED
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
2025
2024
For the Three Months Ended March 31,
2025
2024
Operating expenses
General and administrative
$ 1,360,138
$ 1,885,753
Research and development
746,371
506,155
Depreciation and amortization
81,024
85,409
Total operating expenses
2,187,533
2,477,317
Loss from operations
( 2,187,533 )
( 2,477,317 )
Other income
Other income
2,565
21,437
Interest income, net
2
696
Total other income
2,567
22,133
Net loss before income taxes
( 2,184,966 )
( 2,455,184 )
Income tax expense
—
( 1,731 )
Net loss
( 2,184,966 )
( 2,456,915 )
Other comprehensive loss
Foreign currency translation
( 3,487 )
17,906
Comprehensive loss
$ ( 2,188,453 )
$ ( 2,439,009 )
Net loss per share - basic and diluted
$ ( 1.22 )
$ ( 9.21 )
Weighted average shares outstanding, basic and diluted
1,797,774
266,764
See
the accompanying notes to the unaudited condensed consolidated financial statements.
3
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
UNAUDITED
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY
Shares
Amount
Capital
Deficit
Loss
Equity
FOR THE THREE MONTHS ENDED MARCH 31, 2025
Common Stock
Additional Paid-In
Accumulated
Accumulated Other Comprehensiv e
Total Shareholders’
Shares
Amount
Capital
Deficit
Loss
Equity
Balance at January 1, 2025
678,002
$ 6,780
$ 108,255,049 -
$ ( 106,074,505 )
$ ( 594,517 )
$ 1,592,807
Issuance of common stock and Series A and B and prefunded warrants for cash, net of offering costs of $ 755,487
1,229,330
12,293
4,232,174
—
—
4,244,467
Issuance of common shares for vested RSAs
14,586
146
( 146 )
—
—
—
Issuance of common shares for exercise of warrants
462,336
4,623
70,421
—
—
75,044
Issuance of round up shares
87,402
874
( 874 ) -
—
—
—
Stock based compensation
—
—
193,848
—
—
193,848
Foreign exchange translation loss
—
—
—
—
( 3,487 )
( 3,487 )
Net loss
—
—
—
( 2,184,966 )
—
( 2,184,966 )
Balance at March 31, 2025
2,471,656
$ 24,716
$ 112,750,472 -
$ ( 108,259,471 )
$ ( 598,004 )
$ 3,917,713
See
the accompanying notes to the unaudited condensed consolidated financial statements.
4
ENVERIC BIOSCIENCES,
INC. AND SUBSIDIARIES
UNAUDITED CONDENSED CONSOLIDATED
STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY
Shares
Amount
Capital
Receivable
Deficit
Loss
Equity
FOR THE THREE MONTHS ENDED MARCH 31, 2024
Common Stock
Additional Paid-In
Subscription
Accumulated
Accumulated Other Comprehensive
Total Shareholders’
Shares
Amount
Capital
Receivable
Deficit
Loss
Equity
Balance at January 1, 2024
182,625
1,827
100,841,416
$ ( 1,817,640 )
( 96,499,518 )
( 569,749 )
$ 1,956,336
Balance
182,625
1,827
100,841,416
$ ( 1,817,640 )
( 96,499,518 )
( 569,749 )
$ 1,956,336
Common stock sold under the Equity Distribution Agreement, net of offering costs of $ 583,713
111,200
1,112
1,807,677
—
—
—
1,808,789
Issuance of direct offering shares
15,246
152
322,301
—
—
—
322,453
Exercise of Inducement Warrants for common stock
130,267
1,303
2,675,677
—
—
—
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
46,934
469
( 469 )
1,537,140
—
—
1,537,140
Stock based compensation
—
—
351,488
—
—
—
351,488
Foreign exchange translation gain
—
—
—
—
—
17,906
17,906
Net loss
—
—
—
—
( 2,456,915 )
—
( 2,456,915 )
Balance at March 31, 2024
486,272
$ 4,863
$ 105,985,269
$ —
$ ( 98,956,433 )
$ ( 551,843 )
$ 6,481,856
Balance
486,272
$ 4,863
$ 105,985,269
$ —
$ ( 98,956,433 )
$ ( 551,843 )
$ 6,481,856
See
the accompanying notes to the unaudited condensed consolidated financial statements.
5
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
UNAUDITED
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
2025
2024
For the Three Months Ended March 31,
2025
2024
Cash Flows From Operating Activities:
Net loss
$ ( 2,184,966 )
$ ( 2,456,915 )
Adjustments to reconcile net loss to cash used in operating activities
Change in fair value of warrant liability
( 858 )
( 10,039 )
Change in fair value of investment option liability
( 1,707 )
( 11,398 )
Stock-based compensation
193,848
351,488
Amortization of intangibles
42,182
42,188
Depreciation expense
38,842
43,221
Change in operating assets and liabilities:
Prepaid expenses and other current assets
( 46,126 )
( 759,289 )
Accounts payable, accrued expenses and other current liabilities
( 301,281 )
202,397
Due to related parties
( 131,516 )
—
Net cash used in operating activities
( 2,391,582 )
( 2,598,347 )
Cash Flows From Financing Activities:
Proceeds from sale of common stock and warrants, net of offering costs
4,373,870
—
Proceeds from the exercise of warrants
75,044
2,676,980
Proceeds from the subscription receivable related to the issuance of Inducement Warrants and the exercise of warrants and preferred investment options
—
1,817,640
Proceeds from common stock sold under the Equity Distribution Agreement, net of offering costs
—
2,307,707
Payment for offering costs previously accrued
—
( 144,058 )
Net cash provided by financing activities
4,448,914
6,658,269
Effect of foreign exchange rate on changes on cash
( 3,923 )
8,137
Net increase in cash
2,053,409
4,068,059
Cash at beginning of period
2,241,026
2,287,977
Cash at end of period
$ 4,294,435
$ 6,356,036
Supplemental disclosure of cash flow transactions:
Cash paid for interest
$ —
$ —
Income taxes paid
$ —
$ 24,001
Non-cash financing and investing activities:
Non-cash issuance of round-up shares
$ 874
$ —
Non-cash issuance of RSA vested shares
$ 146
$ —
Offering costs accrued not paid
$ 129,403
$ 49,249
Issuance of common shares for offering costs
$ —
$ 322,453
See
the accompanying notes to the unaudited condensed consolidated financial statements.
6
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 dedicated to the development of novel
neuroplastogenic small-molecule therapeutics for the treatment of depression, anxiety, addiction, and other psychiatric 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., 1236567 B.C. Unlimited Liability Company, MagicMed Industries, Inc. (“MagicMed”), Enveric
Biosciences Canada Inc., Akos Biosciences, Inc. (“Akos”), and Enveric Therapeutics, Pty. Ltd. (“Enveric Therapeutics”).
Enveric’s
lead program, the EVM301 Series, and its lead drug candidate, EB-003, are intended to offer a first-in-class, new approach to the treatment
of difficult-to-address mental health disorders, mediated by the promotion of neuroplasticity and without also inducing hallucinations
in the patient. Previously, Enveric was developing the EVM201 Series, and its lead drug candidate EB-002 (formerly EB-373), for the treatment
of neuropsychiatric disorders. The EVM201 series comprised next generation synthetic prodrugs of the active metabolite, psilocin. In
the fourth quarter of 2024, Enveric out-licensed the EVM201 Series program to MycoMedica Life Sciences, who will seek to develop, manufacture,
and commercialize EB-002, in exchange for certain development and milestone payments to Enveric. The Company’s primary focus is
to develop our lead asset EB-003 in the EVM301 Series.
Reverse
Stock Split
The
Company effected a 1-for-15 reverse stock split (“Reverse Stock Split”) on January 27, 2025, which began trading on a split-adjusted
basis on January 29, 2025, pursuant to which every 15 shares of the Company’s issued and outstanding common stock were reclassified
as one share of common stock. The Reverse Stock Split had no impact on the par value of the Company’s common stock or the authorized
number of shares of common stock. Unless otherwise indicated, all share and per share information prior to the Reverse Stock Split date
of January 29, 2025 in these unaudited condensed consolidated financial statements are retroactively adjusted to reflect the Reverse
Stock Split, prior to the rounding of any fractional shares. Any fractional share resulting from the Reverse Stock Split were rounded
up to the next whole number of shares, upon which 87,402 roundup shares were issued in January 2025.
Going
Concern, Liquidity and Other Uncertainties
The
Company has incurred losses since inception resulting in an accumulated deficit of $ 108,259,471 as of March 31, 2025 and further losses
are anticipated in the development of its business. Further, the Company has operating cash outflows of $ 2,391,582 for the three months
ended March 31, 2025. For the three months ended March 31, 2025, the Company had a loss from operations of $ 2,187,533 . 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 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 March 31, 2025, the
Company had cash of $ 4,294,435 and working capital of
$ 3,650,434 .
The Company’s current cash on hand is not sufficient enough to satisfy its operating cash needs for the 12 months from the
filing of this Quarterly Report on Form 10-Q. These conditions raise substantial doubt regarding the Company’s ability to
continue as a going concern for a period of one year after the date the unaudited condensed consolidated 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 the Company on acceptable terms, or at
all. Should the Company be unable to raise sufficient additional capital, the Company may be required to undertake further
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.
7
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
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 months ended March 31, 2025 are not necessarily indicative of the results that may be expected for the year ending December
31, 2025. These unaudited condensed consolidated financial statements should be read in conjunction with the consolidated financial statements
for the year ended December 31, 2024, 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 28, 2025.
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, 2024. There were no significant changes to these accounting policies during the
three months ended March 31, 2025.
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, 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 consulting expenses within general and administrative
expenses on the unaudited condensed consolidated statements of operations. These expenses were reclassified to research and development
expenses in the current year. Additionally, the Company has reclassified investment option liability and warrant liability to accrued
expenses and other current liabilities on the unaudited condensed consolidated balance sheets and change in fair value of investment
option liability and warrant liability to other income on the unaudited condensed consolidated statements of operations in the current
year. These reclassifications had no effect on the Company’s previously reported results of operations, changes in equity, or cash
flows.
Foreign
Currency Translation
From
inception through March 31, 2025, 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 or the Australian dollar. For the reporting periods ended March 31,
2025 and 2024, 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.
8
ENVERIC BIOSCIENCES,
INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED
FINANCIAL STATEMENTS
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, AUD$ 250,000 in Australia and C$ 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 March 31, 2025, the Company had greater than $ 250,000 at United States financial institutions, less than
AUD$ 250,000 at Australian financial institutions, and more than C$ 100,000 at Canadian financial institutions. As of December 31, 2024,
the Company had greater than $ 250,000 at United States financial institutions, less than AUD$ 250,000 at Australian financial institutions,
and less than C$ 100,000 at Canadian financial institutions.
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. The Company receives no tax benefit from operating losses due to a full valuation allowance.
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 loss per share is computed using the weighted average number of common shares and, if dilutive, potential common shares outstanding
during the period. The Company uses the two-class method to determine earnings per share only when the Company is in an income position.
Potential common shares consist of the incremental common shares issuable upon the exercise of stock options and warrants (using the
treasury stock method). The computation of basic net loss per share for the three months ended March 31, 2025 and 2024 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. In accordance with ASC 260,
4,541 RSUs that were fully vested on March 31, 2025 were included in basic and dilutive earnings per share as there were no remaining
contingencies for these shares to be issued as of March 31, 2025.
Potentially
dilutive securities outlined in the table below have been excluded from the computation of diluted net loss per share the three months
ended March 31, 2025 and 2024 because the effect of their inclusion would have been anti-dilutive.
SCHEDULE OF POTENTIALLY DILUTIVE SECURITIES
2025
2024
For the three months ended March 31,
2025
2024
Warrants to purchase shares of common stock
3,481,267
56,348
Restricted stock units - vested and unissued
3,099
3,132
Restricted stock units - unvested
41,751
23,742
Investment options to purchase shares of common stock
4,667
4,667
Options to purchase shares of common stock
1,538
1,723
Total potentially dilutive securities
3,532,322
89,612
Segment
Reporting
The
Company operates as one operating segment with a focus on developing novel neuroplastogenic small-molecule therapeutics for the treatment
of depression, anxiety, and addiction disorders. The Company’s Chief Executive Officer (“CEO”) as the Chief Operating
Decision Maker (“CODM”), manages and allocates resources to the operations of the Company on a consolidated basis. Consolidated
loss from operations, which is reported in the accompanying unaudited condensed consolidated statements of operations, is the measure
of segment profit or loss that is regularly reviewed by the CODM. This enables the CEO to assess the overall level of available resources
and determine how best to deploy these resources across research and development projects in line with the long-term company-wide strategic
goals. Refer to the accompanying unaudited condensed consolidated statements of operations for the presentation of consolidated loss
from operations for the three months ended March 31, 2025 and 2024. The measure of segment assets is reported in the accompanying unaudited
condensed consolidated balance sheets as “Total assets.” There are no significant segment expenses as the expenses that are
included in consolidated loss from operations are general and administrative and research and development.
9
ENVERIC
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
NOTE
3. PREPAID EXPENSES AND OTHER CURRENT ASSETS
As
of March 31, 2025 and December 31, 2024, the prepaid expenses and other current assets of the Company consisted of the following:
SCHEDULE OF PREPAID EXPENSES AND OTHER CURRENT ASSETS
March 31, 2025
December 31, 2024
Prepaid insurance
$ 394,746
$ 107,610
Prepaid other
89,762
152,894
Prepaid research and development
55,500
—
Prepaid value-added taxes
397
233,054
Total prepaid expenses and other current assets
$ 540,405
$ 493,558
NOTE
4. PROPERTY AND EQUIPMENT
Property
and equipment consists of the following assets which are located in Calgary, Canada, with all amounts translated into U.S. dollars:
SCHEDULE OF PROPERTY AND EQUIPMENT NET OF ACCUMULATED DEPRECIATION
March 31, 2025
December 31, 2024
Lab equipment
$ 769,769
$ 769,105
Computer equipment and leasehold improvements
26,109
26,073
Property and equipment, gross
26,109
26,073
Less: Accumulated depreciation
( 528,599 )
( 489,401 )
Property and equipment, net of accumulated depreciation
$ 267,279
$ 305,777
Depreciation
expense was $ 38,842 and $ 43,221 for the three months ended March 31, 2025 and 2024, respectively.
NOTE
5. ACCRUED LIABILITIES
As
of March 31, 2025 and December 31, 2024, the accrued liabilities of the Company consisted of the following:
SCHEDULE OF ACCRUED LIABILITIES
March 31, 2025
December 31, 2024
Product development
$ 234,614
$ 332,421
Accrued salaries, wages, and bonuses
1,328
1,327
Professional fees
152,173
103,968
Accrued franchise taxes
7,199
261,100
Patent costs
18,000
18,000
Other
523
18,282
Total accrued liabilities
$ 413,837
$ 735,098
NOTE
6. RELATED PARTY TRANSACTIONS
As
of March 31, 2025 and December 31, 2024, there was $ 101,375 and $ 232,891 , respectively, due to related parties. This balance is related
to payments due to board members of the Company. Board member Sheila DeWitt has provided research and development services as an advisory
consultant to the Company since May 2022. These services are provided as needed on an hourly basis. During the three months ended March
31, 2025, the Company incurred $ 3,250 in service fees related to these services. Of these fees, $ 1,750 has been paid and $ 1,500 is included
in due to related parties on the unaudited condensed consolidated balance sheet as of March 31, 2025. During the three months ended March 31, 2024, the Company incurred $ 45,500 in service fees related to these services.
10
ENVERIC BIOSCIENCES,
INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED
FINANCIAL STATEMENTS
NOTE
7. SHARE CAPITAL AND OTHER EQUITY INSTRUMENTS
Public
Offering
On
January 30, 2025, the Company commenced a best efforts public offering (the “Offering”) of an aggregate of (i) 1,229,330
shares (the “Shares”) of Common Stock of the Company, (ii) 437,336 pre-funded warrants (the “Pre-Funded Warrants”)
to purchase 437,336 shares of Common Stock (the “Pre-Funded Warrant Shares”), (iii) 1,666,666 Series A warrants (the “Series
A Warrants”) to purchase 1,666,666 shares of Common Stock (the “Series A Warrant Shares”), and (iv) 1,666,666 Series
B warrants (the “Series B Warrants,” and together with the Series A Warrants, the “Warrants”) to purchase 1,666,666
shares of Common Stock (the “Series B Warrant Shares”). Each Share or Pre-Funded Warrant was sold together with one Series
A Warrant to purchase one share of Common Stock and one Series B Warrant to purchase one share of Common Stock. The offering price for
each Share and accompanying Warrants was $ 3.00 , and the offering price for each Pre-Funded Warrant and accompanying Warrants was $ 2.9999 .
The Pre-Funded Warrants have an exercise price of $ 0.0001 per share, are exercisable immediately and will expire when exercised in full.
Each Warrant has an exercise price of $ 3.00 per share and will be exercisable immediately upon issuance (“Initial Exercise Date”).
The Series A Warrants expire on the five-year anniversary of the Initial Exercise Date. The Series B Warrants expire on the 18-month
anniversary of the Initial Exercise Date.
The
Offering closed on February 3, 2025. The net proceeds of the Offering, after deducting the fees and expenses of the Placement Agent (as
defined below), described in more detail below, and other offering expenses payable by the Company, but excluding the net proceeds, if
any, from the exercise of the Warrants, is $ 4,244,467 .
All
of the warrants issued in connection with the Offering were determined to be equity classified in accordance with the
guidance at ASC 480, Distinguishing Liabilities from Equity and ASC 815-40, Derivatives and Hedging.
In
connection with the Offering, the Company entered into a securities purchase agreement (the “Purchase Agreement”) with a
certain institutional investor. Pursuant to the Purchase Agreement, the Company agreed not to issue, enter into any agreement to issue
or announce the issuance or proposed issuance of any shares of Common Stock or any securities convertible into or exercisable or exchangeable
for shares of Common Stock or file any registration statement or prospectus, or any amendment or supplement thereto for 60 days after
the closing date of the Offering, subject to certain exceptions. In addition, the Company has agreed not to effect or enter into an agreement
to effect any issuance of Common Stock or any securities convertible into or exercisable or exchangeable for shares of Common Stock involving
a variable rate transaction (as defined in the Purchase Agreement) until the one-year anniversary of the closing date of the Offering,
subject to an exception.
A
holder will not have the right to exercise any portion of the Warrants or Pre-Funded Warrants if the holder (together with its affiliates)
would beneficially own in excess of 4.99% or 9.99%, as applicable, of the number of shares of Common Stock outstanding immediately after
giving effect to the exercise, as such percentage ownership is determined in accordance with the terms of the Warrants or the Pre-Funded
Warrants, respectively.
Pursuant
to an engagement agreement, as amended, (the “Engagement Agreement”) with H.C. Wainwright & Co., LLC (the “Placement
Agent”), the Company agreed to pay the Placement Agent in connection with the Offering (i) a cash fee equal to 7.0% of the aggregate
gross proceeds received in the Offering, (ii) a management fee equal to 1.0% of the aggregate gross proceeds received in the Offering,
(iii) a non-accountable expense allowance of $ 25,000 , (iv) reimbursement of up to $ 100,000 for legal fees and expenses and other out
of pocket expenses and (v) up to $ 15,950 for the clearing expenses.
Also
pursuant to the Engagement Agreement, the Company, in connection with the Offering, agreed to issue to the Placement Agent or its designees
warrants (the “Placement Agent Warrants”) to purchase up to an aggregate of 116,666 shares of Common Stock (the “Placement
Agent Warrant Shares”) (which represents 7.0 % of the Shares and Pre-Funded Warrants sold in the Offering). The Placement Agent
Warrants have an exercise price of $ 3.75 per share (which represents 125 % of the public offering price per Share and accompanying Warrants),
expire on February 3, 2030 , and are exercisable following the Initial Exercise Date. The grant date fair value of the Placement Agent
Warrants were $ 147,564 on February 3, 2025 and are were recorded as offering costs . The
measurement of fair value of Placement Agent Warrants were determined utilizing a Black-Scholes model considering all relevant assumptions
current at the date of issuance (i.e., share price of $ 1.81 , exercise price of $ 3.75 , term of five years , volatility of 106 %, risk-free
rate of 4.4 %, and expected dividend rate of 0 %).
As
of March 31, 2025, a total of 437,336 shares of Common Stock have been issued due to exercises of the Pre-Funded Warrants and 25,000
shares of Common Stock have been issued due to exercises of Series B Warrants.
11
ENVERIC BIOSCIENCES,
INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED
FINANCIAL STATEMENTS
Stock
Options
2020
Long-Term Incentive Plan, as amended (“Incentive Plan”)
Effective March 21, 2025, the Board approved an equitable adjustment to increase the number of shares available under the Incentive Plan
by 299,733 shares. As
of March 31, 2025, the total number of shares available for grant under the Incentive Plan was 325,392 .
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 March 31, 2025 and 2024 was $ 414
and $ ( 6,682 ) , respectively.
As
of March 31, 2025, the Company had $ 1,518 in unamortized stock option expense, which will be recognized over a weighted average period
of 0.90 years.
Issuance
of Restricted Stock Units
The
Company’s activity in restricted stock units was as follows for the three months ended March 31, 2025:
SCHEDULE OF RESTRICTED STOCK UNITS
Number of shares
Weighted average fair value
Non-vested at December 31, 2024
48,017
$ 24.08
Granted
—
—
Forfeited
—
—
Vested
( 6,266 )
20.04
Non-vested at March 31, 2025
41,751
$ 24.69
For
the three months ended March 31, 2025 and 2024, the Company recorded $ 193,434 and $ 358,170 , 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. As of March 31, 2025, the Company had unamortized
stock-based compensation costs related to restricted stock units of $ 699,109 which will be recognized over a weighted average period
of 1.86 years. As of March 31, 2025, 7,640 restricted stock units are vested without shares of common stock being issued, with all of
these shares due as of March 31, 2025.
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
2025
2024
Three Months Ended March 31,
2025
2024
Stock-based compensation expense for RSUs:
General and administrative
$ 92,626
$ 152,429
Research and development
100,808
205,741
Total
$ 193,434
$ 358,170
Stock-based compensation expense for RSUs
$ 193,434
$ 358,170
Warrants
The
following table summarizes information about shares issuable under warrants outstanding at March 31, 2025:
SCHEDULE OF WARRANTS OUTSTANDING
Warrant shares outstanding
Weighted average exercise price
Weighted average remaining life
Intrinsic value
Outstanding at December 31, 2024
56,308
$ 536.70
2.7
$ —
Issued
3,887,334
2.69
—
—
Exercised
( 462,336 )
0.16
—
—
Forfeited
( 39 )
1,290.00
—
—
Outstanding at March 31, 2025
3,481,267
11.63
3.2
—
Exercisable at March 31, 2025
3,481,267
$ 11.63
3.2
$ —
12
ENVERIC BIOSCIENCES,
INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED
FINANCIAL STATEMENTS
NOTE
8. LICENSING AGREEMENTS
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.
The
Company has not earned any revenue related to this agreement as of March 31, 2025.
On
November 7, 2024, the Company entered into an Out-Licensing Agreement (the “Agreement”) with MycoMedica Life Sciences, PBC,
a Delaware public benefit corporation (“MycoMedica”), pursuant to which the Company will out-license EB-002 and its EVM201
series to MycoMedica for further development and sales of the product in treatment of neuropsychiatric disorders. MycoMedica will receive
an exclusive, global license to the formulations, drugs, method of use, and medical devices developed by Enveric to utilize the compound.
As part of the Agreement, the Company received a $ 20,000 upfront payment in the fourth quarter of 2024, and if certain conditions are
met, will receive development and sales milestone payments of up to $ 62 million and tiered single-digit royalties based on future sales.
MycoMedica has the option during the license term to buyout its milestone and royalty payment obligations at a predetermined amount depending
upon the stage of product development and commercialization at the time of the buyout. Further, MycoMedica has the right to purchase
the licensed patents at a nominal amount upon a change of control of the Company, although doing so does not relieve MycoMedica of any
of its payment obligations.
The
Company has not earned any revenue related to this agreement during the three months ended March 31, 2025.
On
February 3, 2025, Akos entered into two licensing agreements with Restoration Biologics LLC (“Restoration Biologics”), a
biotechnology company focused on the treatment of joint disease. The companies have executed two licenses for Akos’ cannabinoid-COX-2
conjugate compounds, for pharmaceutical and potential non-pharmaceutical applications.
The
Company has not earned any revenue related to these agreements as of March 31, 2025.
NOTE
9. COMMITMENTS AND CONTINGENCIES
The
Company is periodically involved in legal proceedings, legal actions and claims arising in the normal course of business. Management
believes that the outcome of such legal proceedings, legal actions and claims will not have a significant adverse effect on the Company’s
financial position, results of operations or cash flows.
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 $ 2.8 million in future
cash payments.
NOTE
10. SUBSEQUENT EVENTS
The
Company entered into an at the market offering agreement, or the (“ATM Agreement”), with H.C. Wainwright & Co., LLC,
or (“Wainwright”), acting as sales agent, on April 9, 2025, relating to shares of Common Stock. Under the ATM Agreement,
the Company may offer and sell shares of Common Stock having an aggregate offering price of up to $ 1,854,151 from time to time through
Wainwright.
13
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. These risks and uncertainties include, but are not limited to:
● our
dependence on the success of our prospective product candidates, which are in the early stages
of development and may not reach a particular stage in development, receive regulatory approval,
or be successfully commercialized;
● potential
difficulties that may delay, suspend, or scale back our efforts to advance additional early
research programs through preclinical development and investigational new drug (“IND”)
application filings and into clinical development;
● the
risk that the cost savings, synergies and growth from our combination with MagicMed Industries
Inc. and the successful use of the rights and technologies acquired in the combination may
not be fully realized or may take longer to realize than expected;
● the
limited study on the effects of psychedelic-inspired compounds, 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 psychedelic-inspired compounds;
● 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;
● our
ability to continue as a going concern;
● legislative
changes related to and affecting the healthcare system, including, without limitation, changes
and proposed changes to the Patient Protection and Affordable Care Act (“PPACA”);
● the
intense competition we face, often from companies with greater resources and experience than
us;
● our
ability to retain key executives and scientists;
● the
ability to secure and enforce legal rights related to our products, including intellectual
property rights and patent protection;
● political,
economic, and military instability in Israel which may impede our development programs;
● adverse
macroeconomic conditions; geopolitical tensions; laws and policies resulting from federal
and state governments in the United States and Canada; impact of American trade tariffs and
retaliatory tariffs by other nations;
● the
impact of tariffs and other trade protective measures (including tariffs that have been or
may in the future be imposed by the United States or other countries); and
● our
success at managing the risks involved in the foregoing.
For
a more detailed discussion of these and other factors that may affect our business and that could cause the actual results to differ
materially from those projected in these forward-looking statements, see the risk factors and uncertainties set forth in Part II, Item
1A of this Form 10-Q and Part I, Item 1A of the Annual Report on Form 10-K for the year ended December 31, 2024. 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.
14
Business
Overview
We
are a biotechnology company dedicated to the development of novel neuroplastogenic small-molecule therapeutics for the treatment of depression,
anxiety, addiction, and other psychiatric disorders. Leveraging our unique discovery and development platform, the Psybrary™, which
houses proprietary information on the use and development of existing and novel molecules for specific mental health indications, Enveric
seeks to develop a robust intellectual property portfolio of novel drug candidates.
Enveric’s
lead program, the EVM301 Series, and its lead drug candidate, EB-003, are intended to offer a first-in-class, new approach to the treatment
of difficult-to-address mental health disorders, mediated by the promotion of neuroplasticity and without also inducing hallucinations
in the patient. Enveric unveiled its EVM401 Series on February 25, 2025, which is intended to broaden Enveric’s pipeline with additional
non-hallucinogenic molecules and strengthen its ability to target addiction and neuropsychiatric disorders for patients with limited
options. Previously, Enveric was developing the EVM201 Series, and its drug candidate EB-002 (formerly EB-373), for the treatment of
neuropsychiatric disorders. The EVM201 Series comprised next generation synthetic prodrugs of the active metabolite, psilocin. In the
fourth quarter of 2024, Enveric out-licensed the EVM201 Series program to MycoMedica Life Sciences, who will seek to develop, manufacture,
and commercialize EB-002, in exchange for certain development and milestone payments to Enveric (discussed below).
Neuroplastogens
Following
our amalgamation with MagicMed in September 2021, we have continued to pursue the development of MagicMed’s proprietary library,
the Psybrary™, which we believe will help us to identify and develop the right drug candidates needed to address mental health
challenges, including depression, anxiety, and addiction disorders. We synthesize novel phenylalkylamines and indolethylamines, using
a mixture of chemistry and synthetic biology, resulting in the expansion of the Psybrary™, which currently includes 20 patent families
with claims covering a million potential molecular structures, over one thousand of which we have so far synthesized in sufficient quantities
to identify and hundreds of which we have screened for receptor binding and other relevant activities.
The
Company developed certain intellectual property rights around the trademark PsyAI™ for potential use. On March 6, 2025, Enveric
announced it is soliciting Requests-For Proposals (“RFPs”) for the license or sale of its PsyAI™ trademark portfolio
as a means of maximizing value for an asset which is no longer strategic given the Company’s focus on drug development. This limited
portfolio of US and Canadian trademark assets is held by its subsidiary, Enveric Biosciences Canada, Inc. Enveric expects the period
for RFPs to remain open until August 31, 2025, with a decision to follow within three (3) months thereafter.
At
this stage, we have entered into several non-binding term sheets with strategic partners to out-license certain molecules from the Psybrary™.
Going forward, in order to build a pipeline of product candidates, we intend to both continue to internally develop new drug candidates
with associated intellectual property and to acquire, through in-licensing, additional intellectual property from pharmaceutical and
biotechnology companies and research institutions. The in-licensed assets could include both research stage and clinical stage drug candidates.
15
While
we intend to pursue development of the EVM401 Series, our primary focus is to develop our lead asset EB-003 in the EVM301 Series. The
development status of the product is shown in the table below:
Product
Candidates
Targeted
Indications
Status
Expected
Next Steps
EB-003
Mental
health indication
Preclinical
Development
IND
Filing
Psychedelic-inspired
drug candidate
Recent
Developments
Reverse
Stock Split
We
effected a 1-for-15 reverse stock split on January 27, 2025, which began trading on a split-adjusted basis on January 29, 2025, pursuant
to which every 15 shares of our issued and outstanding common stock were reclassified as one share of common stock. No fractional shares
were issued as a result of the reverse stock split. Any fractional shares that were to otherwise have resulted from the reverse stock
split were rounded up to the next whole number. The reverse stock split had no impact on the par value of our common stock or the authorized
number of shares of our common stock.
January
2025 Offering
On
January 30, 2025, the Company commenced a best efforts public offering (the “Offering”) of an aggregate of (i) 1,229,330
shares (the “Shares”) of common stock of the Company, (ii) 437,336 pre-funded warrants (the “Pre-Funded Warrants”)
to purchase 437,336 shares of common stock (the “Pre-Funded Warrant Shares”), (iii) 1,666,666 Series A warrants (the “Series
A Warrants”) to purchase 1,666,666 shares of common stock (the “Series A Warrant Shares”), and (iv) 1,666,666 Series
B warrants (the “Series B Warrants,” and together with the Series A Warrants, the “Warrants”) to purchase 1,666,666
shares of common stock (the “Series B Warrant Shares”). Each Share or Pre-Funded Warrant was sold together with one Series
A Warrant to purchase one share of common stock and one Series B Warrant to purchase one share of common stock. The offering price for
each Share and accompanying Warrants was $3.00, and the offering price for each Pre-Funded Warrant and accompanying Warrants was $2.9999.
The Pre-Funded Warrants have an exercise price of $0.0001 per share, are exercisable immediately and will expire when exercised in full.
Each Warrant has an exercise price of $3.00 per share and will be exercisable immediately upon issuance (“Initial Exercise Date”).
The Series A Warrants expire on the five-year anniversary of the Initial Exercise Date. The Series B Warrants expire on the 18-month
anniversary of the Initial Exercise Date.
The
Offering closed on February 3, 2025. The net proceeds of the Offering, after deducting the fees and expenses of the Placement Agent (as
defined below) and other offering expenses payable by the Company, but excluding the net proceeds, if any, from the exercise of the Warrants,
is approximately $4.2 million. The Company intends to use the net proceeds from the Offering for working capital, EB-003 development,
and general corporate purposes.
Results
of Operations
The
following table sets forth information comparing the components of net loss for the three months ended March 31, 2025 and 2024:
For the Three Months Ended March 31,
2025
2024
Operating expenses
General and administrative
$ 1,360,138
$ 1,885,753
Research and development
746,371
506,155
Depreciation and amortization
81,024
85,409
Total operating expenses
2,187,533
2,477,317
Loss from operations
(2,187,533 )
(2,477,317 )
Other income
Other income
2,565
21,437
Interest income, net
2
696
Total other income
2,567
22,133
Net loss before income taxes
$ (2,184,966 )
$ (2,455,184 )
Income tax expense
—
(1,731 )
Net loss
$ (2,184,966 )
$ (2,456,915 )
16
General
and Administrative Expenses
Our
general and administrative expenses decreased to $1,360,138 for the three months ended March 31, 2025 from $1,885,753 for the three months
ended March 31, 2024, a decrease of $525,615, or 28%. This change was primarily driven by decreases in director fees of $147,000, accounting
fees of $68,954, legal fees of $48,852, salaries and wages of $56,360, stock compensation expense of $52,703, insurance expenses of $25,994,
audit fees of $23,845, software expense of $21,234, and public company fees of $43,458.
Research
and Development Expenses
Our
research and development expense for the three months ended March 31, 2025 was $746,371 as compared to $506,155 for the three months
ended March 31, 2024 with an increase of $240,216, or approximately 47%. This increase was primarily driven by an increase in consulting
fees of $305,032 and a prior year gain that was realized during the three months ended March 31, 2024 related to the Australian R&D
tax incentive of $399,987, offset by decreases in CRO costs of $398,744, salaries and wages of $147,725 and rent expense of $28,577.
Depreciation
and Amortization Expense
Depreciation
and amortization expense for the three months ended March 31, 2025 was $81,024 as compared to $85,409 for the three months ended March
31, 2024, with a decrease of $4,385, or approximately 5%.
Going
Concern, Liquidity and Capital Resources
The
Company has incurred losses since inception resulting in an accumulated deficit of $108,259,471 as of March 31, 2025 and further losses
are anticipated in the development of its business. For the three months ended March 31, 2025, the Company had a loss from operations
of $2,187,533. Further, the Company had operating cash outflows of $2,391,582 for the three months ended March 31, 2025. Since inception,
being a research and development company, the Company has not 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 March 31, 2025, the
Company had cash of $4,294,435 and working capital of $3,650,434. 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. For example, the Company recently entered into an agreement
with H.C. Wainwright & Co., LLC to conduct an “at-the-market” offering, whereby the Company may offer and sell
shares of its common stock for an aggregate offering price of up to $1.8 million. 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 financial statements. The Company’s unaudited condensed consolidated
financial statements do not include any adjustments that might result from the outcome of this uncertainty.
17
Cash
Flows
Since
inception, we have primarily used our available cash to fund our product development and operations expenditures.
Cash
Flows for the Three Months Ended March 31, 2025 and 2024
The
following table sets forth a summary of cash flows for the years presented:
For the Three Months Ended March 31,
2025
2024
Net cash used in operating activities
$ (2,391,582 )
$ (2,598,347 )
Net cash provided by financing activities
4,448,914
6,658,269
Effect of foreign exchange rate on changes on cash
(3,923 )
8,137
Net increase in cash
$ 2,053,409
$ 4,068,059
Operating
Activities
Net
cash used in operating activities was $2,391,582 during the three months ended March 31, 2025, which consisted primarily of a net loss
adjusted for non-cash items of $1,912,659, an increase in prepaid expenses of $46,126, a decrease in related party expenses of $131,516
and a decrease in accounts payable and accrued liabilities of $301,281.
Net
cash used in operating activities was $2,598,347 during the three months ended March 31, 2024, which consisted primarily of a net loss
adjusted for non-cash items of $2,041,455, an increase in prepaid expenses and other current assets of $759,289, offset by an increase
in accounts payable and accrued liabilities of $202,397.
Financing
Activities
Net
cash provided by financing activities was $4,448,914 during the three months ended March 31, 2025, which consisted of $4,373,870 in proceeds
from the Offering, and $75,044 in proceeds from the exercise of warrants.
Net
cash provided by financing activities was $6,658,269 during the three months ended March 31, 2024, which consisted of $1,817,640 from
the proceeds received from the stock subscription receivable, $2,676,980 for the exercise of the inducement warrants, and $2,307,707
for the common stock sold under a distribution agreement, net of offering costs, and offset by $144,058 offering costs previously accrued
for the inducement warrants.
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, 2024.
18
Item
3. Quantitative and Qualitative Disclosures About Market Risk
Our
primary market risk exposure is foreign currency exchange rate risk. From inception through March 31, 2025, the Company’s reporting
currency is the United States dollar while the functional currency of certain of the Company’s subsidiaries were the Canadian dollar
and Australian dollar. For the reporting periods ended March 31, 2025 and March 31, 2024, 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.
As
required by paragraph (b) of Rules 13a-15 and 15d-15 under the Exchange Act, our Chief Executive Officer (our principal executive)
and Chief Financial Officer (our principal financial officer and principal accounting officer) carried out an evaluation of the
effectiveness of the design and operation of our disclosure controls and procedures as of March 31, 2025. Based on this evaluation,
and in light of the material weaknesses found in our internal controls over financial reporting as of December 31, 2024, our Chief Executive Officer and
Chief Financial Officer concluded that our disclosure controls and procedures (as defined in paragraph (e) of Rules 13a-15 and
15d-15 under the Exchange Act) were not effective as of March 31, 2025.
Management’s
Remediation Plan
As
previously discussed in our Annual Report on Form 10-K for the year ended December 31, 2024, management had concluded that our internal
control over financial reporting was not effective as of December 31, 2024, 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.
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 being undertaken as part of the Company’s 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 March 31,
2025, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
19
PART
II. OTHER INFORMATION
Item
1. Legal proceedings
The
Company may periodically be involved in legal proceedings, legal actions and claims arising in the ordinary course of business. In the
opinion of management, we do not have any pending litigation that, separately or in the aggregate, 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, 2024 as filed with the SEC on March 28, 2025. 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.
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
Exhibit
No.
Description
4.1
Form of Pre-Funded Warrant (incorporated by reference to Exhibit 4.14 of the Company’s Registration Statement on Form S-1/A, filed with the Commission on January 30, 2025)
4.2
Form of Series A Warrant (incorporated by reference to Exhibit 4.15 of the Company’s Registration Statement on Form S-1/A, filed with the Commission on January 30, 2025)
4.3
Form of Series B Warrant (incorporated by reference to Exhibit 4.16 of the Company’s Registration Statement on Form S-1/A, filed with the Commission on January 30, 2025)
4.4
Form of Placement Agent Warrants (incorporated by reference to Exhibit 4.17 of the Company’s Registration Statement on Form S-1/A, filed with the Commission on January 30, 2025)
10.1
Form of Securities Purchase Agreement (incorporated by reference to Exhibit 10.33 of the Company’s Registration Statement on Form S-1/A, filed with the Commission on January 30, 2025)
31.1
Certification pursuant to Section 302 of the Sarbanes–Oxley Act of 2002 of Principal Executive Officer*
31.2
Certification pursuant to Section 302 of the Sarbanes–Oxley Act of 2002 of Principal Financial and Accounting Officer*
32
Certification pursuant to Section 906 of the Sarbanes–Oxley Act of 2002 of Principal Executive Officer, Principal Financial and Accounting Officer**
101.INS
Inline
XBRL Instance Document*
101.SCH
Inline
XBRL Taxonomy Extension Schema*
101.CAL
Inline
XBRL Taxonomy Extension Calculation Linkbase Document*
101.DEF
Inline
XBRL Taxonomy Extension Definition Linkbase Document*
101.LAB
Inline
XBRL Taxonomy Extension Labels Linkbase Document*
101.PRE
Inline
XBRL Taxonomy Extension Presentation Linkbase Document*
104
Cover
Page Interactive Data File (embedded within the Inline XBRL document)
*
Filed
herewith.
**
Furnished
herewith.
20
SIGNATURES
Pursuant
to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed
on its behalf by the undersigned, thereunto duly authorized, on May 14, 2025.
Enveric
Biosciences, Inc.
By:
/s/
Joseph Tucker
Name:
Joseph
Tucker, Ph.D.
Title:
Chief
Executive Officer
(Principal
Executive Officer)
By:
/s/
Kevin Coveney
Name:
Kevin
Coveney
Title:
Chief
Financial Officer
(Principal
Financial and Accounting Officer)
21
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.