ENVB Enveric Biosciences Inc

 

 

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

 

		Page
	PART I - FINANCIAL INFORMATION
Item 1.	Financial Statements
	Condensed Consolidated Balance Sheets as of June 30, 2024 (Unaudited) and December 31, 2023	2
	Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss for the three and six months ended June 30, 2024 and 2023	3
	Unaudited Condensed Consolidated Statements of Changes in Mezzanine Equity and Shareholders’ Equity for the three and six months ended June 30, 2024 and 2023	4
	Unaudited Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2024 and 2023	5
	Notes to Unaudited Condensed Consolidated Financial Statements	6
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	17
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	25
Item 4.	Controls and Procedures	25
	PART II - OTHER INFORMATION	26
Item 1.	Legal Proceedings	26
Item 1A.	Risk Factors	26
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	27
Item 3.	Defaults Upon Senior Securities	27
Item 4.	Mine Safety Disclosures	27
Item 5.	Other Information	27
Item 6.	Exhibits	28
	Signatures	29

 

 

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	)
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 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.

 

6

 

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.

 

7

 

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.

 

8

 

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.

 

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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.

 

10

 

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.

 

11

 

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.

 

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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.

 

13

 

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			$	—

 

14

 

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.

 

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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	)