Form 10-Q - Quarterly report [Sections 13 or 15(d)]

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

☒ Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

For the quarterly period ended: September 30, 2023

☐ Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

For the transition period from ___ to ___

Commission File Number 001-38286

ENVERIC BIOSCIENCES, INC.

(Exact name of registrant as specified in its charter)

Delaware

95-4484725

(State or other jurisdiction of

incorporation or organization)

(IRS Employer

Identification No.)

4851 Tamiami Trail N, Suite 200

Naples, FL

34103

(Address of principal executive offices)

(Zip code)

(239) 302-1707

(Registrant’s telephone number, including area code)

Securities registered pursuant to Section 12(b) of the Act:

Title of Each Class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, $0.01 par value per share		ENVB		The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (Section 232.405 of this chapter) during the preceding 12 months (or such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act:

Large accelerated filer ☐	Accelerated filer ☐
Non-accelerated filer ☒	Smaller reporting company ☒
	Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

As of November 9, 2023, there were 2,321,315 shares outstanding of Registrant’s Common Stock (par value $0.01 per share).

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

FORM 10-Q

TABLE OF CONTENTS

		Page
	PART I - FINANCIAL INFORMATION
Item 1.	Financial Statements
	Condensed Consolidated Balance Sheets as of September 30, 2023 (Unaudited) and December 31, 2022	1
	Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss for the three and nine months ended September 30, 2023 and 2022	2
	Unaudited Condensed Consolidated Statements of Changes in Mezzanine Equity and Shareholders’ Equity for the three and nine months ended September 30, 2023 and 2022	3
	Unaudited Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2023 and 2022	5
	Notes to Unaudited Condensed Consolidated Financial Statements	6
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	21
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	29
Item 4.	Controls and Procedures	29

	PART II - OTHER INFORMATION
Item 1.	Legal Proceedings	30
Item 1A.	Risk Factors	30
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	30
Item 3.	Defaults Upon Senior Securities	30
Item 4.	Mine Safety Disclosures	30
Item 5.	Other Information	30
Item 6.	Exhibits	31
	Signatures	32

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

	September 30, 2023			December 31, 2022
	(unaudited)
ASSETS
Current assets:
Cash	$	4,266,568		$	17,723,884
Prepaid expenses and other current assets		1,560,354			708,053
Total current assets		5,826,922			18,431,937

Other assets:
Property and equipment, net		539,152			677,485
Right-of-use operating lease asset		—			63,817
Intangible assets, net		253,120			379,686
Total other assets		792,272			1,120,988
Total assets	$	6,619,194		$	19,552,925

LIABILITIES, MEZZANINE EQUITY, AND SHAREHOLDERS’ EQUITY
Current liabilities:
Accounts payable	$	1,098,233		$	463,275
Accrued liabilities		1,533,829			1,705,655
Current portion of right-of-use operating lease obligation		—			63,820
Investment option liability		1,250,929			851,008
Warrant liability		300,557			185,215
Derivative liability		—			727,000
Total current liabilities	$	4,183,548		$	3,995,973

Commitments and contingencies (Note 9)		-			-

Mezzanine equity
Series C redeemable preferred stock, $0.01 par value, 100,000 shares authorized, and 0 shares issued and outstanding as of September 30, 2023 and December 31, 2022		—			—
Redeemable non-controlling interest		—			885,028
Total mezzanine equity		—			885,028

Shareholders’ equity
Preferred stock, $0.01 par value, 20,000,000 shares authorized; Series B preferred stock, $0.01 par value, 3,600,000 shares authorized, 0 shares issued and outstanding as of September 30, 2023 and December 31, 2022		—			—
Common stock, $0.01 par value, 100,000,000 shares authorized, 2,181,912 and 2,078,271 shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively		21,818			20,782
Additional paid-in capital		96,013,029			94,395,662
Accumulated deficit		(93,063,582	)		(79,207,786	)
Accumulated other comprehensive loss		(535,619	)		(536,734	)
Total shareholders’ equity		2,435,646			14,671,924
Total liabilities, mezzanine equity, and shareholders’ equity	$	6,619,194		$	19,552,925

See the accompanying notes to the unaudited condensed consolidated financial statements.

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

	2023			2022			2023			2022
	For the Three Months Ended September 30,						For the Nine Months Ended September 30,
	2023			2022			2023			2022
Operating expenses
General and administrative	$	2,010,349		$	3,514,547		$	7,921,340		$	8,783,619
Research and development		1,351,750			2,055,656			5,883,440			6,134,421
Depreciation and amortization		86,296			86,646			259,300			241,413
Total operating expenses		3,448,395			5,656,849			14,064,080			15,159,453

Loss from operations		(3,448,395	)		(5,656,849	)		(14,064,080	)		(15,159,453	)

Other income (expense)
Change in fair value of warrant liabilities		67,822			1,599,623			(115,342	)		3,845,514
Change in fair value of investment option liability		562,715			1,809,622			(399,921	)		1,809,622
Change in fair value of derivative liability		—			(231,000	)		727,000			(284,000	)
Interest income (expense)		2,237			(308	)		3,142			(5,114	)
Total other income		632,774			3,177,937			214,879			5,366,022

Net loss before income taxes		(2,815,621	)		(2,478,912	)		(13,849,201	)		(9,793,431	)

Income tax expense		(6,595	)		—			(6,595	)		—

Net loss		(2,822,216	)		(2,478,912	)		(13,855,796	)		(9,793,431	)
Less preferred dividends attributable to non-controlling interest		—			12,603			19,041			20,411
Less deemed dividends attributable to accretion of embedded derivative at redemption value		—			110,991			147,988			184,985
Net loss attributable to shareholders		(2,822,216	)		(2,602,506	)		(14,022,825	)		(9,998,827	)

Other comprehensive loss
Foreign currency translation		10,433			(417,390	)		1,115			(609,695	)

Comprehensive loss	$	(2,811,783	)	$	(3,019,896	)	$	(14,021,710	)	$	(10,608,522	)

Net loss per share - basic and diluted	$	(1.30	)	$	(1.46	)	$	(6.62	)	$	(8.11	)

Weighted average shares outstanding, basic and diluted		2,164,656			1,787,235			2,117,153			1,232,936

See the accompanying notes to the unaudited condensed consolidated financial statements.

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN MEZZANINE EQUITY AND SHAREHOLDERS’ EQUITY

FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2023 AND 2022

	-	Shares			Amount			Equity			Shares		Amount		Capital			Deficit			Loss			Equity
		Redeemable Non-controlling Interest						Total Mezzanine			Common Stock				Additional Paid-In			Accumulated			Accumulated Other Comprehensive			Total Shareholders’
		Shares			Amount			Equity			Shares		Amount		Capital			Deficit			Loss			Equity
Balance at January 1, 2023	-		1,000		$	885,028		$	885,028			2,078,271	$	20,782	$	94,395,662		$	(79,207,786	)	$	(536,734	)	$	14,671,924
Stock-based compensation			—			—			—			—		—		532,835			—			—			532,835
Preferred dividends attributable to redeemable non-controlling interest			—			12,329			12,329			—		—		(12,329	)		—			—			(12,329	)
Accretion of embedded derivative to redemption value			—			110,991			110,991			—		—		(110,991	)		—			—			(110,991	)
Foreign exchange translation gain			—			—			—			—		—		—			—			1,968			1,968
Net loss	-		—			—			—			—		—		—			(4,677,527	)		—			(4,677,527	)
Balance at March 31, 2023	-		1,000		$	1,008,348		$	1,008,348			2,078,271	$	20,782	$	94,805,177		$	(83,885,313	)	$	(534,766	)	$	10,405,880
Stock-based compensation			—			—			—			—		—		879,738			—			—			879,738
Preferred dividends attributable to redeemable non-controlling interest			—			6,712			6,712			—		—		(6,712	)		—			—			(6,712	)
Accretion of embedded derivative to redemption value			—			36,997			36,997			—		—		(36,997	)		—			—			(36,997	)
Redemption of Series A preferred stock			(1,000	)		(1,052,057	)		(1,052,057	)		—		—		—			—			—			—
Issuance of common shares in exchange for RSU conversions from the reduction in force			—			—			—			63,511		635		(635	)		—			—			—
Foreign exchange translation loss			—			—			—			—		—		—			—			(11,286	)		(11,286	)
Net loss	-		—			—			—			—		—		—			(6,356,053	)		—			(6,356,053	)
Balance at June 30, 2023	-		—		$	—		$	—			2,141,782	$	21,417	$	95,640,571		$	(90,241,366	)	$	(546,052	)	$	4,874,570
Stock-based compensation			—			—			—			—		—		372,859			—			—			372,859
Issuance of common shares in exchange for RSU conversions			—			—			—			40,130		401		(401	)		—			—			—
Foreign exchange translation loss			—			—			—			—		—		—			—			10,433			10,433
Net loss	-		—			—			—			—		—		—			(2,822,216	)		—			(2,822,216	)
Balance at September 30, 2023	-		—		$	—		$	—			2,181,912	$	21,818	$	96,013,029		$	(93,063,582	)	$	(535,619	)	$	2,435,646

See the accompanying notes to the unaudited condensed consolidated financial statements.

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN MEZZANINE EQUITY AND SHAREHOLDERS’ EQUITY

FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2023 AND 2022

	Shares			Amount			Shares		Amount		Equity			Shares		Amount		Capital			Deficit			Income (Loss)			Equity
	Series C Preferred Stock						Redeemable Non-controlling Interest				Total Mezzanine			Common Stock				Additional Paid-In			Accumulated			Accumulated Other Comprehensive			Total Shareholders’
	Shares			Amount			Shares		Amount		Equity			Shares		Amount		Capital			Deficit			Income (Loss)			Equity
Balance at January 1, 2022		—		$	—			—	$	—		—			651,921	$	6,519	$	83,066,656		$	(60,736,453	)	$	(30,802	)	$	22,305,920
February 2022 registered direct offering		—			—			—		—		—			400,000		4,000		5,798,464			—			—			5,802,464
Stock-based compensation		—			—			—		—		—			—		—		768,619			—			—			768,619
Conversion of RSUs into common shares		—			—			—		—		—			899		9		(9	)		—			—			—
Foreign exchange translation gain		—			—			—		—		—			—		—		—			—			88,709			88,709
Net loss		—			—			—		—		—			—		—		—			(4,524,014	)		—			(4,524,014	)
Balance at March 31, 2022		—		$	—			—	$	—	$	—			1,052,820	$	10,528	$	89,633,730		$	(65,260,467	)	$	57,907		$	24,441,698
Stock-based compensation		—			—			—		—		—			—		—		677,543			—			—			677,543
Redeemable non-controlling interest, net of $402,000 embedded derivative and net of issuance costs of $41,962		—			—			1,000		556,038		556,038			—		—		—			—			—			—
Issuance of redeemable non-controlling Series C preferred stock		52,685			527			—		—		527			—		—		(527	)		—			—			(527	)
Preferred dividends attributable to redeemable non-controlling interest		—			—			—		7,808		7,808			—		—		(7,808	)		—			—			(7,808	)
Accretion of embedded derivative to redemption value		—			—			—		73,994		73,994			—		—		(73,994	)		—			—			(73,994	)
Conversion of RSAs into common shares		—			—			—		—		—			1,223		12		(12	)		—			—			—
Foreign exchange translation gain		—			—			—		—		—			—		—		—			—			(281,014	)		(281,014	)
Net loss		—			—			—		—		—			—		—		—			(2,790,505	)		—			(2,790,505	)
Balance at June 30, 2022		52,685		$	527			1,000	$	637,840	$	638,367			1,054,043	$	10,540	$	90,228,932		$	(68,050,972	)	$	(223,107	)	$	21,965,393
Balance		52,685		$	527			1,000	$	637,840	$	638,367			1,054,043	$	10,540	$	90,228,932		$	(68,050,972	)	$	(223,107	)	$	21,965,393
Stock-based compensation		—			—			—		—		—			—		—		645,137			—			—			645,137
July 2022 registered direct offering, PIPE offering, modification of warrants and exercise of pre-funded warrants, net of offering costs		—			—			—		—		—			1,000,000		10,000		3,239,125			—			—			3,249,125
Issuance of rounded shares as a result of the reverse stock split		—			—			—		—		—			24,228		242		(242	)		—			—			—
Preferred dividends attributable to redeemable non-controlling interest		—			—			—		12,603		12,603			—		—		(12,603	)		—			—			(12,603	)
Accretion of embedded derivatives to redemption value		—			—			—		110,991		110,991			—		—		(110,991	)		—			—			(110,991	)
Redemption of Series C preferred stock		(52,685	)		(527	)		—		—		(527	)		—		—		527			—			—			527
Foreign exchange translation loss		—			—			—		—		—			—		—		—			—			(417,390	)		(417,390	)
Net loss		—			—			—		—		—			—		—		—			(2,478,912	)		—			(2,478,912	)
Balance at September 30, 2022		—		$	—			1,000	$	761,434	$	761,434			2,078,271	$	20,782	$	93,989,885		$	(70,529,884	)	$	(640,497	)	$	22,840,286
Balance		—		$	—			1,000	$	761,434	$	761,434			2,078,271	$	20,782	$	93,989,885		$	(70,529,884	)	$	(640,497	)	$	22,840,286

See the accompanying notes to the unaudited condensed consolidated financial statements.

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

	2023			2022
	For the Nine Months Ended
	2023			2022
Cash Flows From Operating Activities:
Net loss	$	(13,855,796	)	$	(9,793,431	)
Adjustments to reconcile net loss to cash used in operating activities
Change in fair value of warrant liability		115,342			(3,845,514	)
Change in fair value of investment option liability		399,921			(1,809,622	)
Change in fair value of derivative liability		(727,000	)		284,000
Stock-based compensation		1,785,432			2,091,299
Amortization of right-of-use asset		64,246			103,365
Amortization of intangible assets		126,566			126,563
Depreciation expense		132,734			114,850
Gain on disposal of property and equipment		(4,219	)		—
Change in operating assets and liabilities:
Prepaid expenses and other current assets		(746,033	)		(758,419	)
Accounts payable and accrued liabilities		429,688			(106,675	)
Right-of-use operating lease liability		(64,244	)		(91,022	)
Net cash used in operating activities		(12,343,363	)		(13,684,606	)

Cash Flows From Investing Activities:
Purchases of property and equipment		(5,195	)		(577,972	)
Proceeds from disposal of property and equipment		16,900			—
Net cash provided by (used in) investing activities		11,705			(577,972	)

Cash Flows From Financing Activities:
Payment for the deferred offering costs from the equity distribution agreement		(105,000	)		—
Proceeds from sale of common stock, warrants, and investment options, net of offering costs		—			17,222,100
Redemption of Series A Preferred Stock (see Note 8)		(1,052,057	)		—
Proceeds from the sale of redeemable non-controlling interest, net of offering		—			958,038
Net cash (used in) provided by financing activities		(1,157,057	)		18,180,138

Effect of foreign exchange rate on cash		31,399			(72,554	)

Net (decrease) increase in cash		(13,457,316	)		3,845,006
Cash at beginning of period		17,723,884			17,355,999
Cash at end of period	$	4,266,568		$	21,201,005

Supplemental disclosure of cash and non-cash transactions:
Cash paid for interest	$	—		$	5,114
Income taxes paid	$	6,595		$	—
Warrants issued in conjunction with common stock issuance	$	—		$	3,595,420
Issuance of embedded derivative	$	—		$	402,000
Issuance of redeemable non-controlling Series C preferred stock	$	—		$	—
Offering costs accrued not paid	$	20,800		$	—
Preferred dividends attributable to redeemable non-controlling interest	$	19,041		$	20,411
Accretion of embedded derivative to redemption value	$	147,988		$	184,985
Investment options issued in conjunction with common stock issuance	$	—		$	4,323,734
Modification of warrants as part of share capital raise	$	—		$	251,357

See the accompanying notes to the unaudited condensed consolidated financial statements.

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

NOTE 1. BUSINESS AND LIQUIDITY AND OTHER UNCERTAINTIES

Nature of Operations

Enveric Biosciences, Inc. (“Enveric” or the “Company”) is a biotechnology company developing novel neuroplastogenic small-molecule therapeutics for the treatment of depression, anxiety, and addiction disorders. The head office of the Company is located in Naples, Florida. The Company has the following wholly-owned subsidiaries: Jay Pharma Inc. (“Jay Pharma”), 1306432 B.C. Ltd. (“HoldCo”), MagicMed Industries, Inc. (“MagicMed”), Enveric Canada Inc., and Enveric Therapeutics, Pty. Ltd. (“Enveric Therapeutics”).

Leveraging its unique discovery and development platform, The Psybrary™, Enveric has created a robust Intellectual Property portfolio of New Chemical Entities for specific mental health indications. Enveric’s lead program, the EVM201 Series, comprises next generation synthetic prodrugs of the active metabolite, psilocin. Enveric is developing the first product from the EVM201 Series – EB-373 – for the treatment of psychiatric disorders. Enveric is also advancing its second program, the EVM301 Series, expected to offer a first-in-class, new approach to the treatment of difficult-to-address mental health disorders, mediated by the promotion of neuroplasticity without also inducing hallucinations in the patient.

Following the Company’s amalgamation with MagicMed completed in September 2021 (the “Amalgamation”), the Company has continued to pursue the development of MagicMed’s proprietary Psychedelic Derivatives library, the Psybrary™ which the Company believes will help to identify and develop the right drug candidates needed to address mental health challenges, including cancer-related distress. The Company synthesizes novel versions of classic psychedelics, such as psilocybin, DMT, mescaline and MDMA, using a mixture of chemistry and synthetic biology, resulting in the expansion of the Psybrary™, which includes 15 patent families with over a million potential variations and hundreds of synthesized molecules. Within the Psybrary™ the Company has three different types of molecules, Generation 1 (classic psychedelics), Generation 2 (pro-drugs), and Generation 3 (new chemical entities). The Company is working to add novel psychedelic molecular compounds and derivatives (“Psychedelic Derivatives”) on a regular basis through its work at the Company’s labs in Calgary, Alberta, Canada, where the Company has a team of PhD scientists with expertise in synthetic biology and chemistry. To date the Company has created over 500 molecules that are housed in the Psybrary™.

The Company screens newly synthesized molecules in the Psybrary™ through PsyAI™, a proprietary artificial intelligence (“AI”) tool. Leveraging AI systems is expected to reduce the time and cost of pre-clinical, clinical, and commercial development. The Company believes it streamlines pharmaceutical design by predicting ideal binding structures of molecules, manufacturing capabilities, and pharmacological effects to help determine ideal drug candidates, tailored to each indication. Each of these molecules that the Company believes are patentable can then be further screened to see how changes to its makeup alter its effects in order to synthesize additional new molecules. New compounds of sufficient purity are undergoing pharmacological screening, including non-clinical (receptors/cell lines), preclinical (animal), and ultimately clinical (human) evaluations. The Company intends to utilize the Psybrary™ and the AI tool to categorize and characterize the Psybrary™ substituents to focus on bringing more psychedelics-inspired molecules from discovery to the clinical phase.

Akos Spin-Off

On May 11, 2022, the Company announced plans to transfer and spin-off its cannabinoid clinical development pipeline assets to Akos Biosciences, Inc. (formerly known as Acanna Therapeutics, Inc.), a majority-owned subsidiary of the Company (hereafter referred to as “Akos”), which was incorporated on April 13, 2022, by way of dividend to Enveric shareholders (the “Spin-Off”). As of May 12, 2023, the holders of the Company’s Akos Series A Preferred Stock, par value $0.01 per share (“Akos Series A Preferred Stock”) have exercised this right to force redemption of all of the Akos Series A Preferred Stock for $1,000 per share, plus accrued but unpaid dividends of $52,057 for a total of $1,052,057. The Company made full payment on May 19, 2023. See Note 8.

Australian Subsidiary

On March 21, 2023, the Company established Enveric Therapeutics, an Australia-based subsidiary, to support the Company’s plans to advance its lead program, the EVM201 Series, comprised of the next generation synthetic prodrugs of the active metabolite, psilocin (“EVM201 Series”), towards the clinic. Enveric Therapeutics will oversee the Company’s preclinical, clinical, and regulatory activities in Australia, including ongoing interactions with the local Human Research Ethics Committees (HREC) and the Therapeutic Goods Administration (TGA), Australia’s regulatory authority.

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

Going Concern, Liquidity and Other Uncertainties

The Company has incurred a loss since inception resulting in an accumulated deficit of $93,063,582 as of September 30, 2023, and further losses are anticipated in the development of its business. Further, the Company had operating cash outflows of $12,343,363 for the nine months ended September 30, 2023. For the nine months ended September 30, 2023, the Company had a loss from operations of $14,064,080. Since its inception, being a research and development company, the Company has not yet generated revenue and the Company has incurred continuing losses from its operations. The Company’s operations have been funded principally through the issuance of debt and equity. These factors raise substantial doubt about the Company’s ability to continue as a going concern for a period of one year from the issuance of these financial statements.

In assessing the Company’s ability to continue as a going concern, the Company monitors and analyzes its cash and its ability to generate sufficient cash flow in the future to support its operating and capital expenditure commitments. At September 30, 2023, the Company had cash of $4,266,568 and working capital of $1,643,374. The Company’s current cash on hand is insufficient to satisfy its operating cash needs for the 12 months following the filing of this Quarterly Report on Form 10-Q. These conditions raise substantial doubt regarding the Company’s ability to continue as a going concern for a period of one year after the date the financial statements are issued. Management’s plan to alleviate the conditions that raise substantial doubt include reducing the Company’s rate of spend, managing its cash flow, advancing its programs, and raising additional working capital through public or private equity or debt financings or other sources, which has included the Equity Distribution Agreement with Canaccord for proceeds of up to $2.4 million (see Note 7) and the Purchase Agreement with Lincoln Park (see Note 10), subject to registration, and may include collaborations with additional third parties, as well as disciplined cash spending, to increase the Company’s cash runway. Adequate additional financing may not be available to the Company on acceptable terms, or at all. Should the Company be unable to raise sufficient additional capital, the Company may be required to undertake cost-cutting measures including delaying or discontinuing certain operating activities.

The Company’s material cash requirements consist of working capital to fund capital expenditures incurred at their research facility in Calgary and their operations, which consist primarily of, without limitation, employee related expenses, product development activities conducted by third parties, research materials and lab supplies, facility related expenses including rent and maintenance, costs associated with preclinical studies, patent related costs, costs of regulatory and public company compliance, insurance costs, audit costs, consultants and legal fees. Additionally, the Company currently utilizes third-party contract research organizations (“CROs”) to assist with clinical development activities. If the Company obtains regulatory approval for any of their product candidates, they expect to incur significant expenses to engage third-party contract manufacturing organizations (“CMOs”) to carry out their clinical manufacturing activities as it does not yet have a commercialization infrastructure, and incur significant expenses related to developing its internal commercialization capability to support product sales, marketing and distribution. The Company’s current working capital resources are insufficient to fund these material cash requirements for the next twelve months.

As a result of these factors, management has concluded that there is substantial doubt about the Company’s ability to continue as a going concern for a period of one year after the date of the financial statements are issued. The Company’s unaudited condensed consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

Reduction in Force/Restructuring

On June 16, 2023, the Company entered into a separation agreement with Avani Kanubaddi, the Company’s President and Chief Operating Officer (the “Kanubaddi Separation Agreement”). In accordance with the Kanubaddi Separation Agreement, Mr. Kanubaddi’s outstanding restricted stock units (“RSUs”) will retain their vesting conditions. Mr. Kanubaddi’s 2023 salary and benefits of $550,974 were accrued and will be paid out in twelve equal monthly installments beginning in July 2023. Upon termination, any unvested time-based RSUs became fully vested. The Company accelerated expense recognized related to these shares that vested was $231,273. Of the 11,278 market performance-based RSUs previously granted, 3,759 will continue to be subject to the original terms and conditions of Mr. Kanubaddi’s employment agreement and the remainder were forfeited.

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

SCHEDULE OF RESTRUCTURING COSTS PAYABLE

	Accrued Restructuring Costs
January 1, 2023 Beginning balance	$	—
Restructuring costs incurred		1,004,033
Restructuring costs paid		(396,431	)
September 30, 2023 ending balance	$	607,602

Inflation Risks

The Company considers the current inflationary trend existing in the North American economic environment reasonably likely to have a material unfavorable impact on results of continuing operations. Higher rates of price inflation, as compared to recent prior levels of price inflation, have caused a general increase in the cost of labor and materials. In addition, there is an increased risk of the Company experiencing labor shortages due to a potential inability to attract and retain human resources due to increased labor costs resulting from the current inflationary environment.

NOTE 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Basis of Presentation and Principal of Consolidation

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) for interim financial information and Article 8 of Regulation S-X. Accordingly, they do not include all the information and footnotes required by U.S. GAAP for complete financial statements. Management’s opinion is that all adjustments (consisting of normal accruals) considered necessary for a fair presentation have been included. Operating results for the three and nine months ended September 30, 2023 are not necessarily indicative of the results that may be expected for the year ending December 31, 2023. These unaudited condensed consolidated financial statements should be read in conjunction with the consolidated financial statements for the year ended December 31, 2022, and related notes thereto included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on March 31, 2023 and subsequently amended on Form 10-K/A Amendment No. 1 filed with the SEC on June 9, 2023 (as amended, the “Annual Report”).

The Company’s significant accounting policies and recent accounting standards are summarized in Note 2 of the Company’s consolidated financial statements for the year ended December 31, 2022. There were no significant changes to these accounting policies during the three and nine months ended September 30, 2023.

Use of Estimates

The preparation of the unaudited condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amount of assets and liabilities at the date of the financial statements and expenses during the periods reported. By their nature, these estimates are subject to measurement uncertainty and the effects on the financial statements of changes in such estimates in future periods could be significant. Significant areas requiring management’s estimates and assumptions include determining the fair value of transactions involving common stock and the valuation of stock-based compensation, accruals associated with third party providers supporting research and development efforts, and estimated fair values of long lived assets used to record impairment charges related to intangible assets. Actual results could differ from those estimates.

Foreign Currency Translation

From inception through September 30, 2023, the reporting currency of the Company was the United States dollar while the functional currency of certain of the Company’s subsidiaries was the Canadian dollar and Australian dollar. For the reporting periods ended September 30, 2023 and 2022, the Company engaged in a number of transactions denominated in Canadian dollars and Australian dollars. As a result, the Company is subject to exposure from changes in the exchange rates of the Canadian dollar and Australian dollar against the United States dollar.

The Company translates the assets and liabilities of its Canadian subsidiaries and Australian subsidiary into the United States dollar at the exchange rate in effect on the balance sheet date. Revenues and expenses are translated at the average exchange rate in effect during each monthly period. Unrealized translation gains and losses are recorded as foreign currency translation gain (loss), which is included in the condensed consolidated statements of shareholders’ equity as a component of accumulated other comprehensive loss.

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

The Company has not entered into any financial derivative instruments that expose it to material market risk, including any instruments designed to hedge the impact of foreign currency exposures. The Company may, however, hedge such exposure to foreign currency exchange fluctuations in the future.

Adjustments that arise from exchange rate changes on transactions denominated in a currency other than the local currency are included in other comprehensive loss in the condensed consolidated statements of operations and comprehensive loss as incurred.

Concentration of Credit Risk

Financial instruments that potentially subject the Company to concentrations of credit risk consist of cash accounts in a financial institution, which at times, may exceed the federal depository insurance coverage of $250,000 in the United States and Australia and $100,000 in Canada. The Company has not experienced losses on these accounts, and management believes the Company is not exposed to significant risks on such accounts. As of September 30, 2023, the Company had greater than $250,000 at United States financial institutions, less than $250,000 at Australian financial institutions, and greater than $100,000 at Canadian financial institutions.

Deferred Offering Costs

The Company complies with the requirements of ASC Topic 340, Other Assets and Deferred Costs (“ASC 340”) and SAB 5A - Expenses of Offering. Offering costs, which consist mainly of legal, accounting and consulting fees directly attributable to the issuance of an equity contract to be classified in equity are recorded as a reduction in equity. During September 2023, the Company incurred $125,800 in deferred offering costs in connection with the Equity Distribution Agreement (the “Distribution Agreement”), with Canaccord Genuity LLC (“Canaccord”) and the Purchase Agreement (the “Purchase Agreement”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”). These deferred offering costs will be proportionately offset against the total proceeds from the issuance of common stock available under the agreements and the Company will expense any remaining balance of deferred offering costs if the agreements are terminated. For the three and nine months ended September 30, 2023, there were no issuances of common stock under the agreements resulting in the deferral of offering costs.

Warrant Liability and Investment Options

The Company evaluates all of its financial instruments, including issued stock purchase warrants and investment options, to determine if such instruments are derivatives or contain features that qualify as embedded derivatives, pursuant to ASC 480 “Distinguishing Liabilities from Equity” (“ASC 480”) and FASB ASC Topic 815, “Derivatives and Hedging” (“ASC 815”). The Company accounts for warrants and investment options for shares of the Company’s common stock that are not indexed to its own stock as derivative liabilities at fair value on the unaudited condensed consolidated balance sheets. The Company accounts for common stock warrants and investment options with put options as liabilities under ASC 480. Such warrants and investment options are subject to remeasurement at each unaudited condensed consolidated balance sheet date and any change in fair value is recognized as a component of other expense on the unaudited condensed consolidated statements of operations. The Company will continue to adjust the liability for changes in fair value until the earlier of the exercise or expiration of such common stock warrants and investment options. At that time, the portion of the warrant liability and investment options related to such common stock warrants will be reclassified to additional paid-in capital.

Derivative Liability

The Company evaluates its financial instruments to determine if such instruments are derivatives or contain features that qualify as embedded derivatives in accordance with ASC 815. For derivative financial instruments that are accounted for as assets or liabilities, the derivative instrument is initially recorded at its fair value on the grant date and is then re-valued at each reporting date, with changes in the fair value reported in the unaudited condensed consolidated statements of operations. The classification of derivative instruments, including whether such instruments should be recorded as assets or liabilities or as equity, is evaluated at the end of each reporting period. Derivative liabilities are classified in the unaudited condensed consolidated balance sheets as current or non-current based on whether or not net-cash settlement or conversion of the instrument could be required within 12 months of the balance sheet date.

Income Taxes

The Company files U.S. federal and state returns. The Company’s foreign subsidiary also files a local tax return in their local jurisdiction. From a U.S. federal, state, and Canadian perspective, the years that remain open to examination are consistent with each jurisdiction’s statute of limitations.

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

Net Loss per Share

Basic net loss per share is computed by dividing net loss by the weighted average number of shares of common stock outstanding during the period. Diluted earnings per share is computed using the weighted average number of common shares and, if dilutive, potential common shares outstanding during the period. Potential common shares consist of the incremental common shares issuable upon the exercise of stock options and warrants (using the treasury stock method). The computation of basic net loss per share for the three and nine months ended September 30, 2023 and 2022 excludes potentially dilutive securities. The computations of net loss per share for each period presented is the same for both basic and fully diluted. In accordance with ASC 260 “Earnings per Share” (“ASC 260”), penny warrants were included in the calculation of weighted average shares outstanding for the purposes of calculating basic and diluted earnings per share.

Potentially dilutive securities outlined in the table below have been excluded from the computation of diluted net loss per share the three and nine months ended September 30, 2023 and 2022 because the effect of their inclusion would have been anti-dilutive.

	For the three and nine months ended September 30, 2023		For the three and nine months ended September 30, 2022
Warrants to purchase shares of common stock		609,893		655,463
Restricted stock units - vested and unissued		20,847		61,428
Restricted stock units - unvested		148,251		65,117
Restricted stock awards - vested and unissued		—		974
Investment options to purchase shares of common stock		1,070,000		1,070,000
Options to purchase shares of common stock		31,852		22,829
Total potentially dilutive securities		1,880,843		1,875,811

Fair Value Measurements

Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. To increase the comparability of fair value measures, the following hierarchy prioritizes the inputs to valuation methodologies used to measure fair value:

Level 1 - Valuations based on quoted prices for identical assets and liabilities in active markets.

Level 2 - Valuations based on observable inputs other than quoted prices included in Level 1, such as quoted prices for similar assets and liabilities in active markets, quoted prices for identical or similar assets and liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable market data.

Level 3 - Valuations based on unobservable inputs reflecting our own assumptions, consistent with reasonably available assumptions made by other market participants. These valuations require significant judgment.

For certain financial instruments, including cash and accounts payable, the carrying amounts approximate their fair values as of September 30, 2023, and December 31, 2022 because of their short-term nature.

The following table provides the financial liabilities measured on a recurring basis and reported at fair value on the balance sheet as of September 30, 2023, and December 31, 2022, and indicates the fair value of the valuation inputs the Company utilized to determine such fair value of warrant liabilities, derivative liability, and investment options:

	Level	September 30, 2023		December 31, 2022
Warrant liabilities - January 2021 Warrants	3	$	18	$	81
Warrant liabilities - February 2021 Warrants	3		59		79
Warrant liabilities - February 2022 Warrants	3		300,480		185,055
Fair value of warrant liability		$	300,557	$	185,215

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

	Level	September 30, 2023		December 31, 2022
Derivative liability - May 2022	3	$	—	$	727,000
Fair value of derivative liability		$	—	$	727,000

	Level	September 30, 2023		December 31, 2022
H.C. Wainwright & Co., LLC investment options	3	$	70,521	$	44,904
RD investment options	3		442,653		302,289
PIPE investment options	3		737,755		503,815
Fair value of investment option liability		$	1,250,929	$	851,008

The warrant liabilities, derivative liability, and investment options are all classified as Level 3, for which there is no current market for these securities such as the determination of fair value requires significant judgment or estimation. Changes in fair value measurement categorized within Level 3 of the fair value hierarchy are analyzed each period based on changes in estimates or assumptions and recorded within other income (expense) on the condensed consolidated statements of operations and comprehensive loss.

Subsequent measurement

The following table presents the changes in fair value of the warrant liabilities, derivative liability, and investment options that are classified as Level 3:

	Total Warrant Liabilities
Fair value as of December 31, 2022	$	185,215
Change in fair value		115,342
Fair value as of September 30, 2023	$	300,557

	Total Derivative Liability
Fair value as of December 31, 2022	$	727,000
Change in fair value arising from redemption of Akos Series A Preferred Stock - See Note 8		(727,000	)
Fair value of derivative liability as of September 30, 2023	$	—

	Total Investment Option Liability
Fair value as of December 31, 2022	$	851,008
Change in fair value		399,921
Fair value of investment option liability as of September 30, 2023	$	1,250,929

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

The key inputs into the Black Scholes valuation model for the Level 3 valuations of the warrant liabilities as of September 30, 2023 are below:

	January 2021 Warrants			February 2021 Warrants			February 2022 Warrants			February 2022 Post-Modification Warrants
Term (years)		2.3			2.4			3.4			4.3
Stock price	$	2.38		$	2.38		$	2.38		$	2.38
Exercise price	$	247.50		$	245.00		$	27.50		$	7.78
Dividend yield		—	%		—	%		—	%		—	%
Expected volatility		80.0	%		85.0	%		96.0	%		94.0	%
Risk free interest rate		5.00	%		4.90	%		4.80	%		4.70	%
Number of warrants		36,429			34,281			338,000			122,000
Value (per share)	$	—		$	—		$	0.46		$	1.18

The key inputs into the Black Scholes valuation model for the Level 3 valuations of the investment options as of September 30, 2023 are below:

	H.C. Wainwright & Co., LLC Options			RD Offering Options			PIPE Offering Options
Term (years)		3.8			4.3			4.3
Stock price	$	2.38		$	2.38		$	2.38
Exercise price	$	10.00		$	7.78		$	7.78
Dividend yield		—	%		—	%		—	%
Expected volatility		97.0	%		94.0	%		94.0	%
Risk free interest rate		4.70	%		4.70	%		4.70	%
Number of investment options		70,000			375,000			625,000
Value (per share)	$	1.01		$	1.18		$	1.18

The key inputs into the Weighted Expected Return valuation model for the Level 3 valuations of the derivative liability as of redemption, are below:

		May 2022 Derivative Liability
Principal	$	—
Dividend rate		—	%
Market rate		—	%

At the date of the redemption of the of Akos Series A Preferred Stock in May 2023, the derivative liability fair value was $0 due to the probability of a spin-off occurring was zero. See Note 8

Redeemable Non-controlling Interest

In connection with the issuance of Akos Series A Preferred Stock, the Akos Purchase Agreement (as defined below in Note 8) and certificate of designation contain a put right guaranteed by the Company as defined in Note 8. Applicable accounting guidance requires an equity instrument that is redeemable for cash or other assets to be classified outside of permanent equity if it is redeemable (a) at a fixed or determinable price on a fixed or determinable date, (b) at the option of the holder, or (c) upon the occurrence of an event that is not solely within the control of the issuer. As a result of this feature, the Company recorded the non-controlling interests as redeemable non-controlling interests and classified them in mezzanine equity within its unaudited condensed consolidated balance sheet initially at its acquisition-date estimated redemption value or fair value. In addition, the Company has elected to recognize changes in the redemption value immediately as they occur and adjust the carrying amount of the instrument by accreting the embedded derivative at each reporting period over 12 months.

In May 2023, pursuant to the Akos Series A Preferred Certificate of Designations, the holders of the Akos Series A Preferred Stock exercised the Put Right (as defined below) requiring Akos to force redemption of all of the Akos Series A Preferred Stock. See Note 8.

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

Segment Reporting

The Company determines its reporting units in accordance with FASB ASC 280, “Segment Reporting” (“ASC 280”). The Company evaluates a reporting unit by first identifying its operating segments under ASC 280. The Company then evaluates each operating segment to determine if it includes one or more components that constitute a business. If there are components within an operating segment that meet the definition of a business, the Company evaluates those components to determine if they must be aggregated into one or more reporting units. If applicable, when determining if it is appropriate to aggregate different operating segments, the Company determines if the segments are economically similar and, if so, the operating segments are aggregated. The Company has multiple operations related to psychedelics and cannabinoids. Both of these operations exist under one reporting unit: Enveric. The Company has one operating segment and reporting unit. The Company is organized and operated as one business. Management reviews its business as a single operating segment, using financial and other information rendered meaningful only by the fact that such information is presented and reviewed in the aggregate.

Recent Accounting Pronouncements

In August 2020, the FASB issued ASU 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40) (“ASU 2020-06”) to simplify certain financial instruments. ASU 2020-06 eliminates the current models that require separation of beneficial conversion and cash conversion features from convertible instruments and simplifies the derivative scope exception guidance pertaining to equity classification of contracts in an entity’s own equity. The new standard also introduces additional disclosures for convertible debt and freestanding instruments that are indexed to and settled in an entity’s own equity. ASU 2020-06 amends the diluted earnings per share guidance, including the requirement to use the if-converted method for all convertible instruments. ASU 2020-06 is effective for fiscal years beginning after December 15, 2023, and should be applied on a full or modified retrospective basis. Early adoption is permitted, but no earlier than fiscal years beginning after December 15, 2020, including interim periods within those fiscal years. The Company early adopted ASU 2020-06 effective January 1, 2023, and has determined that the adoption of this guidance had no impact on its condensed consolidated financial statements.

NOTE 3. PREPAID EXPENSES AND OTHER CURRENT ASSETS

As of September 30, 2023 and December 31, 2022, the prepaid expenses and other current assets of the Company consisted of the following:

	September 30, 2023		December 31, 2022
Prepaid research and development	$	651,623	$	268,686
Prepaid value-added taxes		229,909		159,782
Prepaid professional fees		74,500		—
Prepaid insurance		332,508		174,406
Prepaid other		146,014		105,179
Deferred offering costs		125,800		—
Total prepaid expenses and other current assets	$	1,560,354	$	708,053

NOTE 4. INTANGIBLE ASSETS

As of September 30, 2023, the Company’s intangible assets consisted of:

Definite lived intangible assets
Balance at December 31, 2022	$	379,686
Amortization		(126,566	)
Balance at September 30, 2023	$	253,120

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

For identified definite lived intangible assets, there was no impairment expense during the three and nine months ended September 30, 2023 and 2022. For identified definite lived intangible assets, amortization expense amounted to $42,191 during the three months ended September 30, 2023, and 2022, respectively. For identified definite lived intangible assets, amortization expense amounted to $126,566 and $126,563 during the nine months ended September 30, 2023 and 2022.

NOTE 5. PROPERTY AND EQUIPMENT

Property and equipment consists of the following assets which are located in Calgary, Canada and placed in service by Enveric Biosciences Canada, Inc. (“EBCI”), with all amounts translated into U.S. dollars:

	September 30, 2023			December 31, 2022
Lab equipment	$	818,460		$	831,123
Computer equipment and leasehold improvements		27,759			25,137
Less: Accumulated depreciation		(307,067	)		(178,775	)
Property and equipment, net of accumulated depreciation	$	539,152		$	677,485

Depreciation expense was $44,105 and $44,458 for the three months ended September 30, 2023, and 2022, respectively. Depreciation expense was $132,734 and $114,850 for the nine months ended September 30, 2023 and 2022, respectively.

NOTE 6. ACCRUED LIABILITIES

As of September 30, 2023 and December 31, 2022, the accrued liabilities of the Company consisted of the following:

SCHEDULE OF ACCRUED LIABILITIES

	September 30, 2023		December 31, 2022
Product development	$	94,663	$	195,104
Accrued salaries and wages		729,616		1,175,963
Professional fees		74,499		83,255
Accrued restructuring costs		607,602		—
Accrued franchise taxes		9,449		—
Patent costs		18,000		251,333
Total accrued expenses	$	1,533,829	$	1,705,655

NOTE 7. SHARE CAPITAL AND OTHER EQUITY INSTRUMENTS

Authorized Capital

The holders of the Company’s common stock are entitled to one vote per share. Holders of common stock are entitled to receive ratably such dividends, if any, as may be declared by the Board of Directors out of legally available funds. Upon the liquidation, dissolution, or winding up of the Company, holders of common stock are entitled to share ratably in all assets of the Company that are legally available for distribution. As of September 30, 2023, 100,000,000 shares of common stock and 20,000,000 shares of Preferred Stock were authorized under the Company’s articles of incorporation.

Equity Distribution Agreement

On September 1, 2023, the Company entered into the Distribution Agreement, with Canaccord, pursuant to which the Company may offer and sell from time to time, through Canaccord as sales agent and/or principal, shares of common stock of the Company, par value $0.01 per share having an aggregate offering price of up to $10.0 million. Due to the offering limitations applicable to the Company and in accordance with the terms of the Distribution Agreement, the Company may offer Common Stock having an aggregate gross sales price of up to $2,392,514 pursuant to the prospectus supplement dated September 1, 2023 (the “Prospectus Supplement”). Subject to the terms and conditions of the Distribution Agreement, Canaccord may sell the Common Stock by any method permitted by law deemed to be an “at-the-market offering”. The Company will pay Canaccord a commission equal to 3.0% of the gross sales price of the Common Stock sold through Canaccord under the Distribution Agreement and has also agreed to reimburse Canaccord for certain expenses. The Company may also sell Common Stock to Canaccord as principal for Canaccord’s own account at a price agreed upon at the time of sale. Any sale of Common Stock to Canaccord as principal would be pursuant to the terms of a separate terms agreement between the Company and Canaccord.

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

During the three and nine months ended September 30, 2023, the Company has issued no shares of common stock through the Distribution Agreement. The Company had capitalized deferred offering costs of $125,800 related to establishing the Distribution Agreement with Canaccord and the Purchase Agreement with Lincoln Park and no reductions to additional paid in capital.

Common Stock Activity

On February 15, 2022, the Company completed a public offering of 400,000 shares of Common Stock and warrants to purchase up to 400,000 shares of Common Stock for gross proceeds of approximately $10.0 million, before deducting underwriting discounts and commissions and other offering expenses. A.G.P./Alliance Global Partners acted as sole book-running manager for the offering. In addition, Enveric granted the underwriter a 45-day option to purchase up to an additional 60,000 shares of Common Stock and/or warrants to purchase up to an additional 60,000 shares of Common Stock at the public offering price, which the underwriter has partially exercised for warrants to purchase up to 60,000 shares of common stock. At closing, Enveric received net proceeds from the offering of approximately $9.1 million, after deducting underwriting discounts and commissions and estimated offering expenses with $5.8 million allocated to equity, $3.6 million to warrant liability and the remaining $0.3 million recorded as an expense.

On July 22, 2022, the Company entered into a securities purchase agreement (the “Registered Direct Securities Purchase Agreement”) with an institutional investor for the purchase and sale of 116,500 shares of the Company’s common stock, pre-funded warrants to purchase up to 258,500 shares of common stock (the “RD Pre-Funded Warrants”), and unregistered preferred investment options (the “RD Preferred Investment Options”) to purchase up to 375,000 shares of common stock (the “RD Offering”). The gross proceeds from the RD Offering were approximately $3,000,000. Subject to certain ownership limitations, the RD Pre-Funded Warrants became immediately exercisable at an exercise price equal to $0.0001 per share of common stock. On August 3, 2022, all of the issued RD Pre-Funded Warrants were exercised.

Concurrently with the RD Offering, the Company entered into a securities purchase agreement (the “PIPE Securities Purchase Agreement”) with institutional investors for the purchase and sale of 116,000 shares of common stock, pre-funded warrants to purchase up to 509,000 shares of common stock (the “PIPE Pre-Funded Warrants”), and preferred investment options (the “PIPE Preferred Investment Options”) to purchase up to 625,000 shares of the common stock in a private placement (the “PIPE Offering”). The gross proceeds from the PIPE Offering were approximately $5,000,000. Subject to certain ownership limitations, the PIPE Pre-Funded Warrants became immediately exercisable at an exercise price equal to $0.0001 per share of common stock. All of the issued PIPE Pre-Funded Warrants were exercised on various dates prior to August 18, 2022.

The RD Offering and PIPE Offering closed on July 26, 2022, with aggregate gross proceeds of approximately $8 million. The aggregate net proceeds from the offerings, after deducting the placement agent fees and other estimated offering expenses, were approximately $7.1 million, with $3.2 million allocated to equity, $4.3 million to investment option liability, and the remaining $0.4 million recorded as an expense.

During the nine months ended September 30, 2023, a total of 103,641 shares of Common Stock were issued pursuant to the conversion of restricted stock units. During the nine months ended September 30, 2022, a total of 2,122 shares of Common Stock were issued pursuant to the conversion of restricted stock units.

Stock Options

Amendment to 2020 Long-Term Incentive Plan

On May 3, 2022, our board of directors (“Board”) adopted the First Amendment (the “Plan Amendment”) to the Enveric Biosciences, Inc. 2020 Long-Term Incentive Plan (the “Incentive Plan”) to (i) increase the aggregate number of shares available for the grant of awards by 146,083 shares to a total of 200,000 shares, and (ii) add an “evergreen” provision whereby the number of shares authorized for issuance pursuant to awards under the Incentive Plan will be automatically increased on the first trading date immediately following the date the Company issues any share of Common Stock (defined below) to any person or entity, to the extent necessary so that the number of shares of the Company’s Common Stock authorized for issuance under the Incentive Plan will equal the greater of (x) 200,000 shares, and (y) 15% of the total number of shares of the Company’s Common Stock outstanding as of such issuance date. The Plan Amendment was approved by the Company’s shareholders at a special meeting of the Company’s shareholders held on July 14, 2022.

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

A summary of activity under the Company’s incentive plan for the nine months ended September 30, 2023, is presented below:

SCHEDULE OF STOCK OPTION

	Number of Shares			Weighted Average Exercise Price		Weighted Average Grant Date Fair Value		Weighted Average Remaining Contractual Term (years)		Aggregate Intrinsic Value
Outstanding at December 31, 2022		48,329		$	37.05	$	44.82		4.1	$	—
Forfeited		(16,476	)	$	5.79	$	5.80		—	$	—
Outstanding at September 30, 2023		31,852		$	53.18	$	74.04		3.4	$	—
Exercisable at September 30, 2023		24,626		$	63.72	$	86.52		3.0	$	—

The Company’s stock-based compensation expense, recorded within general and administrative expense in the condensed consolidated statement of operations and comprehensive loss, related to stock options for the three months ended September 30, 2023, and 2022 was $44,606 and $48,697, respectively. The Company’s stock-based compensation expense, recorded within general and administrative expense, related to stock options for the nine months ended September 30, 2023 and 2022 was $147,067 and $134,383, respectively. As of September 30, 2023, the Company had $93,697 in unamortized stock option expense, which will be recognized over a weighted average period of 1 year.

Restricted Stock Awards

For the three months ended September 30, 2023, and 2022, the Company recorded $0 and $6,250, respectively, in stock-based compensation expense within general and administrative expense, related to restricted stock awards. For the nine months ended September 30, 2023 and 2022, the Company recorded $0 and $24,363, respectively, in stock-based compensation expense within general and administrative expense, related to restricted stock awards. As of September 30, 2023, there were no unamortized stock-based compensation costs related to restricted share awards. During the three months ended September 30, 2023, the Company settled the 708 vested and unissued shares for cash of $14,250. As of September 30, 2023, there are 0 vested and unissued shares of restricted stock awards.

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

Issuance of Restricted Stock Units

The Company’s activity in restricted stock units was as follows for the nine months ended September 30, 2023:

	Number of shares			Weighted average fair value
Non-vested at December 31, 2022		64,053		$	92.57
Granted		182,500		$	2.73
Vested		(62,636	)	$	19.80
Forfeited		(35,666	)	$	27.45
Non-vested at September 30, 2023		148,251		$	28.39

For the three months ended September 30, 2023, and 2022, the Company recorded $328,253 and $590,190, respectively, in stock-based compensation expense related to restricted stock units. For the nine months ended September 30, 2023 and 2022, the Company recorded $1,638,365 and $1,932,553 respectively, in stock-based compensation expense related to restricted stock units, which is a component of both general and administrative and research and development expenses in the condensed consolidated statement of operations and comprehensive loss. As of September 30, 2023, the Company had unamortized stock-based compensation costs related to restricted stock units of $2,388,221 which will be recognized over a weighted average period of 2.3 years and unamortized stock-based costs related to restricted stock units which will be recognized upon achievement of specified milestones. As of September 30, 2023, 20,847 restricted stock units are vested without shares of common stock being issued, with all of these shares due as of September 30, 2023.

The following table summarizes the Company’s recognition of stock-based compensation for restricted stock units for the following periods:

	2023		2022		2023		2022
	Three months ended September 30,				Nine months ended September 30,
	2023		2022		2023		2022
Stock-based compensation expense for RSUs:
General and administrative	$	101,607	$	357,756	$	946,851	$	1,138,080
Research and development		226,646		232,434		691,514		794,473
Total	$	328,253	$	590,190	$	1,638,365	$	1,932,553

Warrants

The following table summarizes information about shares issuable under warrants outstanding on September 30, 2023:

SCHEDULE OF WARRANTS OUTSTANDING

	Warrant shares outstanding			Weighted average exercise price		Weighted average remaining life		Intrinsic value
Outstanding at December 31, 2022		655,463		$	58.36		3.6	$	5,514
Expired		(45,570	)	$	111.50		—	$	—
Outstanding at September 30, 2023		609,893		$	50.46		2.9	$	—
Exercisable at September 30, 2023		609,893		$	50.46		2.9	$	—

The warrants assumed pursuant to the acquisition of MagicMed contain certain down round features, which were not triggered by the February 2022 public offering and July 2022 RD Offering, that would require adjustment to the exercise price upon certain events when the offering price is less than the stated exercise price.

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

Preferred Investment Options

The following table summarizes information about investment options outstanding on September 30, 2023:

	Investment options outstanding		Weighted average exercise price		Weighted average remaining life		Intrinsic value
Outstanding at December 31, 2022		1,070,000	$	7.93		5.1	$	—
Outstanding at September 30, 2023		1,070,000	$	7.93		4.3	$	—
Exercisable at September 30, 2023		1,070,000	$	7.93		4.3	$	—

NOTE 8. REDEEMABLE NON-CONTROLLING INTEREST

Spin-Off and Related Private Placement

In connection with the Spin-Off, on May 5, 2022, Akos and the Company entered into into a Securities Purchase Agreement (the “Akos Purchase Agreement”) with an accredited investor (the “Akos Investor”), pursuant to which Akos agreed to sell up to an aggregate of 5,000 shares of Akos Series A Preferred Stock, at price of $1,000 per share, and warrants (the “Akos Warrants”) Akos Warrants to purchase shares of Akos’ common stock, par value $0.01 per share (the “Akos Common Stock”), for an aggregate purchase price of up to $5,000,000 (the “Akos Private Placement”). The Akos Purchase Agreement was guaranteed by the Company. Pursuant to the Akos Purchase Agreement, Akos issued 1,000 shares of the Akos Series A Preferred Stock to the Akos Investor in exchange for $1,000,000 on May 5, 2022. The additional $4,000,000 was to be received on or immediately prior to the Spin-Off. The issuance of the Akos Series A Preferred Stock results in RNCI (see Note 2). Palladium Capital Advisors, LLC (“Palladium”) acted as placement agent for the Akos Private Placement. Pursuant to the Akos Purchase Agreement, Akos had agreed to pay Palladium a fee equal to 9% of the aggregate gross proceeds raised from the sale of the shares of the Akos Series A Preferred Stock and a non-accountable expense allowance of 1% of the aggregate gross proceeds raised the sale of the Akos Series A Preferred Stock in the Akos Private Placement. The fee due in connection with the Akos Private Placement to be paid to Palladium in the form of convertible preferred stock and warrants was on similar terms to the securities issued in the Akos Private Placement. Palladium was also entitled to warrants to purchase Akos Common Stock in an amount up to 8% of the number of shares of Akos Common Stock underlying the shares issuable upon conversion of the Akos Series A Preferred Stock. As of September 30, 2023, no accruals are required to be recorded for the fees or warrants since the Akos Series A Preferred Stock has been redeemed.

Terms of Akos Series A Preferred Stock

Under the Certificate of the Designations, Preferences, and Rights of Series A Convertible Preferred Stock of Akos (the “Akos Series A Preferred Certificate of Designations”), on or immediately prior to the completion of the spin-off of Akos into an independent, separately traded public company listed on the Nasdaq Stock Market, the outstanding Akos Series A Preferred Stock automatically converted into a number of shares of Akos Common Stock equal to 25% of the then issued and outstanding Akos Common Stock, subject to the Beneficial Ownership Limitation (as defined in the Akos Purchase Agreement). Cumulative dividends on each share of Akos Series A Preferred Stock accrue at the rate of 5% annually.

The Akos Series A Preferred Certificate of Designations provided that upon the earlier of (i) the one-year anniversary of May 5, 2022, and only in the event that the Spin-Off has not occurred; or (ii) such time that Akos and the Company have abandoned the Spin-Off or the Company is no longer pursuing the Spin-Off in good faith, the holders of the Akos Series A Preferred Stock shall have the right (the “Put Right”), but not the obligation, to cause Akos to purchase all or a portion of the Akos Series A Preferred Stock for a purchase price equal to $1,000 per share, subject to certain adjustments as set forth in the Akos Series A Preferred Certificate of Designations (the “Stated Value”), plus all the accrued but unpaid dividends per share. In addition, after the one-year anniversary of May 5, 2022, and only in the event that the Spin-Off has not occurred and Akos is not in material default of any of the transaction documents, Akos may, at its option, at any time and from time to time, redeem the outstanding shares of Akos Series A Preferred Stock, in whole or in part, for a purchase price equal to the aggregate Stated Value of the shares of Akos Series A Preferred Stock being redeemed and the accrued and unpaid dividends on such shares. Pursuant to the Akos Purchase Agreement, the Company has guaranteed the payment of the purchase price for the shares purchased under the Put Right.

The Akos Series A Preferred Certificate of Designations contains limitations that prevent the holder thereof from acquiring shares of Akos Common Stock upon conversion of the Akos Series A Preferred Stock that would result in the number of shares of Akos Common Stock beneficially owned by such holder and its affiliates exceeding 9.99% of the total number of shares of Akos Common Stock outstanding immediately after giving effect to the conversion (the “Beneficial Ownership Limitation”), except that upon notice from the holder to Akos, the holder may increase or decrease the limit of the amount of ownership of outstanding shares of Akos Common Stock after converting the holder’s shares of Akos Series A Preferred Stock, provided that any change in the Beneficial Ownership Limitation shall not be effective until 61 days following notice to Akos.

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

Redemption of Akos Series A Preferred Stock

In May 2023, pursuant to the Akos Series A Preferred Certificate of Designations, the holders of the Akos Series A Preferred Stock exercised the Put Right requiring Akos to force redemption of all of the Akos Series A Preferred Stock for $1,000 per share, plus accrued but unpaid dividends of approximately $52,000 for a total of approximately $1,052,000. The Company had 20 days following the receipt of the Put Exercise Notice to make the payment and made payment on May 19, 2023. Upon redemption in May 2023, the Company revalued the derivative liability and the Company recognized a change in fair value of the derivative liability on the Company’s condensed consolidated statement of operations during the second quarter of 2023 of $714,000.

The Company, Akos, and the Akos Investor have terminated the Akos Purchase Agreement in connection with the planned Spin-Off and certain registration rights agreement in connection with the Akos Private Placement.

Accounting for Akos Series A Preferred Stock

Since the shares of Akos Series A Preferred Stock were redeemable at the option of the holder and the redemption is not solely in the control of the Company, the shares of Akos Series A Preferred Stock were accounted for as a redeemable non-controlling interest and classified within mezzanine equity in the Company’s condensed consolidated balance sheets. The redeemable non-controlling interest was initially measured at fair value. Dividends on the shares of Akos Series A Preferred Stock were recognized as preferred dividends attributable to redeemable non-controlling interest in the Company’s condensed consolidated statement of operations and comprehensive loss.

The table below presents the reconciliation of changes in redeemable non-controlling interest:

Balance at December 31, 2022	$	885,028
Preferred dividends attributable to redeemable non-controlling interest		19,041
Accretion of embedded derivative and transaction costs associated with Akos Series A Preferred		147,988
Redemption of Akos Series A Preferred Stock		(1,052,057	)
Balance at September 30, 2023	$	—

In May 2023, the Akos Series A Preferred Stock was redeemed for a total of $1,052,057, and the balance of the redeemable non-controlling interest is $0 as of September 30, 2023.

NOTE 9. COMMITMENTS AND CONTINGENCIES

The Company is periodically involved in legal proceedings, legal actions and claims arising in the normal course of business. Management believes that the outcome of such legal proceedings, legal actions and claims will not have a significant adverse effect on the Company’s financial position, results of operations or cash flows.

Australian Subsidiary Research and Development

On March 23, 2023, the Company issued a press release announcing the selection of Australian CRO, Avance Clinical, in preparation for Phase 1 Study of EB-373, the Company’s lead candidate targeting the treatment of anxiety disorders. Under the agreement, Avance Clinical will manage the Phase 1 clinical trial of EB-373 in coordination with the Company’s newly established Australian subsidiary, Enveric Therapeutics Pty, Ltd. The Phase 1 clinical trial is designed as a multi-cohort, dose-ascending study to measure the safety and tolerability of EB-373. EB-373, a next-generation proprietary psilocin prodrug, has been recognized as a New Chemical Entity (NCE) by Australia’s Therapeutic Goods Administration (TGA) and is currently in preclinical development targeting the treatment of anxiety disorder. The total cost of the Avance Clinical contract is approximately 3,000,000 AUD, which translates to approximately $2,000,000 USD as of September 30, 2023. As of September 30, 2023, the Company has paid approximately $950,997 of the Avance Clinical contract costs and has $549,713 recorded as prepaid assets within prepaid and other current assets on the accompanying condensed consolidated balance sheet. For the three and nine months ended September 30, 2023, the Company has expensed $157,117 and $401,284 in research and development expenses, respectively, within the accompanying condensed consolidated statement of operations.

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

Development and Clinical Supply Agreement

On February 22, 2021, the Company entered into a Development and Clinical Supply Agreement (the “PureForm Agreement”) with PureForm Global, Inc. (“PureForm”), pursuant to which PureForm will be the exclusive provider of synthetic cannabidiol (“API”) for the Company’s development plans for cancer treatment and supportive care. Under the terms of the PureForm Agreement, PureForm has granted the Company the exclusive right to purchase API and related product for cancer treatment and supportive care during the term of the Agreement (contingent upon an initial minimum order of 1 kilogram during the first thirty (30) days from the effective date) and has agreed to manufacture, package and test the API and related product in accordance with specifications established by the parties. All inventions that are developed jointly by the parties in the course of performing activities under the PureForm Agreement will be owned jointly by the parties in accordance with applicable law; however, if the Company funds additional research and development efforts by PureForm, the parties may enter into a further agreement whereby PureForm would assign any resulting inventions or technical information to the Company.

The initial term of the PureForm Agreement is three (3) years commencing on the effective date of the PureForm Agreement, subject to extension by mutual agreement of the parties. The PureForm Agreement may be terminated by either party upon thirty (30) days written notice of an uncured material breach or immediately in the event of bankruptcy or insolvency. The PureForm Agreement contains, among other provisions, representation and warranties, indemnification obligations and confidentiality provisions in favor of each party that are customary for an agreement of this nature.

The Company has met the minimum purchase requirement of 1 kilogram during the first thirty days of the PureForm Agreement’s effectiveness.

Purchase agreement with Prof. Zvi Vogel and Dr. Ilana Nathan

On December 26, 2017, Jay Pharma entered into a purchase agreement with Prof. Zvi Vogel and Dr. Ilana Nathan (the “Vogel-Nathan Purchase Agreement”), pursuant to which Jay Pharma was assigned ownership rights to certain patents, which were filed and unissued as of the date of the Vogel-Nathan Purchase Agreement. The Vogel-Nathan Purchase Agreement includes a commitment to pay a one-time milestone totaling $200,000 upon the issuance of a utility patent in the United States or by the European Patent Office, as defined in the agreement. The Company has accrued such amount as of December 31, 2021, as a result of the milestone criteria being achieved. Payment was made during January 2022. In addition, a milestone payment totaling $300,000 is due upon initiation of a Phase II(b) study. Research activities related to the relevant patents are still in pre-clinical stage, and accordingly, this milestone has not been achieved. The Vogel-Nathan Purchase Agreement contains a commitment for payment of royalties equaling 2% of the first $20 million in net sales derived from the commercialization of products utilizing the relevant patent. As these products are still in the preclinical phase of development, no royalties have been earned.

Other Consulting and Vendor Agreements

The Company has entered into a number of agreements and work orders for future consulting, clinical trial support, and testing services, with terms ranging between 1 and 18 months. These agreements, in aggregate, commit the Company to approximately $1.2 million in future cash payments.

NOTE 10. SUBSEQUENT EVENTS

Lincoln Park Equity Line

On November 3, 2023, the Company entered into a Purchase Agreement and a registration rights agreement (the “Registration Rights Agreement”), with Lincoln Park, pursuant to which Lincoln Park has committed to purchase up to $10.0 million of the Company’s common stock, par value $0.01 per share subject to certain limitations and satisfaction of the conditions set forth in the Purchase Agreement.

Under the terms and subject to the conditions of the Purchase Agreement, the Company has the right, but not the obligation, to sell to Lincoln Park, and Lincoln Park is obligated to purchase up to $10.0 million of the Company’s Common Stock (the “Purchase Shares”). However, such sales of Common Stock by the Company, if any, will be subject to important limitations set forth in the Purchase Agreement, including limitations on number of shares that may be sold. Sales may occur from time to time, at the Company’s sole discretion, over the 24-month period commencing on the date that the conditions to Lincoln Park’s purchase obligation set forth in the Purchase Agreement are satisfied, including that a registration statement on Form S-1 covering the resale of the shares of our Common Stock that have been and may be issued to Lincoln Park under the Purchase Agreement, which the Company has filed with the SEC pursuant to the Registration Rights Agreement, is declared effective by the SEC and a final prospectus relating thereto is filed with the SEC.

Because the purchase price per share to be paid by Lincoln Park for the shares of Common Stock that we may elect to sell to Lincoln Park under the Purchase Agreement, if any, will fluctuate based on the market prices of our Common Stock at the time we elect to sell shares to Lincoln Park pursuant to the Purchase Agreement, if any, it is not possible for us to predict the number of shares of Common Stock that we will sell to Lincoln Park under the Purchase Agreement, the purchase price per share that Lincoln Park will pay for shares purchased from us under the Purchase Agreement, or the aggregate gross proceeds that we will receive from those purchases by Lincoln Park under the Purchase Agreement.

For additional details, please refer to the Company’s Current Report on Form 8-K filed with the SEC on November 6, 2023.

2020 Long-Term Incentive Plan Amended

On November 2, 2023, the shareholders approved the amendments to the 2020 Long-Term Incentive Plan, which was approved by the Board on August 8, 2023 (the “Amended Incentive Plan”). The Amended Incentive Plan increased the number of authorized shares reserved for issuance under the Amended Incentive Plan to a maximum of 350,000, subject to adjustment.

Item 2. Management’s discussion and analysis of financial condition and results of operations

The information set forth below should be read in conjunction with the unaudited condensed consolidated financial statements and notes thereto included elsewhere in this Quarterly Report on Form 10-Q. Unless stated otherwise, references in this Quarterly Report on Form 10-Q to “us,” “we,” “our,” or our “Company” and similar terms refer to Enveric Biosciences, Inc., a Delaware corporation.

Cautionary Note Regarding Forward-Looking Statements

This quarterly report on Form 10-Q (this “Form 10-Q”) contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of forward-looking terms such as “anticipates,” “assumes,” “believes,” “can,” “could,” “estimates,” “expects,” “forecasts,” “guides,” “intends,” “is confident that,” “may,” “plans,” “seeks,” “projects,” “targets,” and “would” or the negative of such terms or other variations on such terms or comparable terminology. Such forward-looking statements include, but are not limited to, future financial and operating results, the company’s plans, objectives, expectations and intentions and other statements that are not historical facts. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition, and results of operations. These forward-looking statements speak only as of the date of this Form 10-Q and are subject to a number of risks, uncertainties, and assumptions that could cause actual results to differ materially from our historical experience and our present expectations, or projections described under the sections in this Form 10-Q entitled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” These risks and uncertainties include, but are not limited to:

	●	our dependence on the success of our prospective product candidates, which are in the early stages of development and may not reach a particular stage in development, receive regulatory approval, or be successfully commercialized;
	●	potential difficulties that may delay, suspend, or scale back our efforts to advance additional early research programs through preclinical development and investigational new drug (“IND”) application filings and into clinical development;
	●	the risk that the cost savings, synergies and growth from our combination with MagicMed Industries Inc. and the successful use of the rights and technologies acquired in the combination may not be fully realized or may take longer to realize than expected;
	●	the ongoing impact of the novel coronavirus (COVID-19) on our business, including our current plans for product development, as well as any currently ongoing preclinical studies and clinical trials and any future studies or other development or commercialization activities;
	●	the limited study on the effects of medical cannabinoids and psychedelics, and the chance that future clinical research studies may lead to conclusions that dispute or conflict with our understanding and belief regarding the medical benefits, viability, safety, efficacy, dosing, and social acceptance of cannabinoids or psychedelics;
	●	the expensive, time-consuming, and uncertain nature of clinical trials, which are susceptible to change, delays, termination, and differing interpretations;
	●	the ability to establish that potential products are efficacious or safe in preclinical or clinical trials;
	●	the fact that our current and future preclinical and clinical studies may be conducted outside the United States, and the United States Food and Drug Administration may not accept data from such studies to support any new drug applications we may submit after completing the applicable developmental and regulatory prerequisites;
	●	our ability to effectively and efficiently build, maintain and legally protect our molecular derivatives library so that it can be an essential building block from which those in the biotech industry can develop new patented products;
	●	our ability to establish or maintain collaborations on the development of therapeutic candidates;
	●	our ability to obtain appropriate or necessary governmental approvals to market potential products;
	●	our ability to manufacture product candidates on a commercial scale or in collaborations with third parties;
	●	our significant and increasing liquidity needs and potential requirements for additional funding;
	●	our ability to obtain future funding for developing products and working capital and to obtain such funding on commercially reasonable terms;
	●	legislative changes related to and affecting the healthcare system, including, without limitation, changes and proposed changes to the Patient Protection and Affordable Care Act;
	●	the intense competition we face, often from companies with greater resources and experience than us;
	●	our ability to retain key executives and scientists;
	●	the ability to secure and enforce legal rights related to our products, including intellectual property rights and patent protection;
	●	political, economic, and military instability in Israel which may impede our development programs;
	●	our success at managing the risks involved in the foregoing; and
	●	the risk of loss in excess of insurance limitations on funds help in U.S Banking Institutions.

For a more detailed discussion of these and other factors that may affect our business and that could cause the actual results to differ materially from those projected in these forward-looking statements, see the risk factors and uncertainties set forth in Part II, Item 1A of this Form 10-Q and Part I, Item 1A of the Annual Report. Any one or more of these uncertainties, risks and other influences could materially affect our results of operations and whether forward-looking statements made by us ultimately prove to be accurate. We undertake no obligation to publicly update or revise any forward-looking statements, whether from new information, future events or otherwise, except as required by law.

Business Overview

We are a biotechnology company dedicated to the development of novel neuroplastogenic small-molecule therapeutics for the treatment of depression, anxiety, and addiction disorders. Leveraging its unique discovery and development platform, The Psybrary™, Enveric has created a robust intellectual property portfolio of New Chemical Entities for specific mental health indications. Enveric’s lead program, the EVM201 Series, comprises next generation synthetic prodrugs of the active metabolite, psilocin. Enveric is developing the first product from the EVM201 Series – EB-373 – for the treatment of psychiatric disorders. Enveric is also advancing its second program, the EVM301 Series, expected to offer a first-in-class, new approach to the treatment of difficult-to-address mental health disorders, mediated by the promotion of neuroplasticity without also inducing hallucinations in the patient.

Psychedelics

Following our amalgamation with MagicMed completed in September 2021 (the “Amalgamation”), we have continued to pursue the development of MagicMed’s proprietary Psychedelic Derivatives library, the Psybrary™ which we believe will help us to identify and develop the right drug candidates needed to address mental health challenges, including cancer-related distress. We synthesize novel versions of classic psychedelics, such as psilocybin, N-dimethyltryptamine (DMT), mescaline and MDMA, using a mixture of chemistry and synthetic biology, resulting in the expansion of the Psybrary™, which includes 15 patent families with over a million potential variations and hundreds of synthesized molecules. Within the Psybrary™ we have three different types of molecules, Generation 1 (classic psychedelics), Generation 2 (pro-drugs), and Generation 3 (new chemical entities). The Company is working to add novel psychedelic molecular compounds and Psychedelic Derivatives on a regular basis through our work at Enveric Labs in Calgary, Alberta, Canada, where we have a team of PhD scientists with expertise in synthetic biology and chemistry. To date we have created over 500 molecules that are housed in the Psybrary.

We screen newly synthesized molecules in the Psybrary™ through PsyAI™, a proprietary AI tool. Leveraging AI systems is expected to reduce the time and cost of pre-clinical, clinical, and commercial development. We believe it streamlines pharmaceutical design by predicting ideal binding structures of molecules, manufacturing capabilities, and pharmacological effects to help determine ideal drug candidates, tailored to each indication. Each of these molecules that we believe are patentable can then be further screened to see how changes to its makeup alter its effects in order to synthesize additional new molecules. New compounds of sufficient purity are undergoing pharmacological screening, including non-clinical (receptors/cell lines), preclinical (animal), and ultimately clinical (human) evaluations. We intend to utilize our Psybrary™ and the AI tool to categorize and characterize the Psybrary™ substituents to focus on bringing more psychedelics-inspired molecules from discovery to the clinical phase.

Cannabinoids

We aim to advance a pipeline of novel cannabinoid combination therapies for the side effects of cancer treatments, such as chemotherapy and radiotherapy.

We intend to bring together leading oncology clinicians, researchers, academic and industry partners to develop both external proprietary products and a robust internal pipeline of product candidates aimed at improving quality of life and outcomes for cancer patients. We intend to evaluate options to out-license our proprietary technology as it moves along the regulatory pathway.

In developing our product candidates, we intend to focus on cannabinoids derived from non-hemp botanical sources, and synthetic materials containing no tetrahydrocannabinol (“THC”) in order to comply with U.S. federal regulations. Of the potential cannabinoids to be used in therapeutic formulations, THC, which is responsible for the psychoactive properties of marijuana, can result in undesirable mood effects. Selected cannabidiol (CBD) and cannabigerol (CBG) candidates, on the other hand, have amounts of THC well below 0.1% and are not psychotropic and therefore more attractive candidates for translation into therapeutic practice. Drugs with less than 0.1% THC have a history, when approved as drugs by the Food and Drug Administration “FDA”, of being able to be rescheduled by DEA from Schedule I to Schedule V, as in the case of Epidiolex and Marinol. In the future, we may utilize cannabinoids that are derived from cannabis plants, which may contain higher amounts of THC; however, we only intend to do so in jurisdictions where THC is legal. However, synthetic THC is a Schedule I controlled substance; so, the use of any APIs (Active Pharmaceutical Ingredients) containing synthetic THC (or naturally derived THC in concentrations greater than 0.3%) may increase regulatory scrutiny and require additional expenses and authorizations. All current and future product candidates that we are developing or may develop will be tested for safety and efficacy under an IND application and subject to the FDA pre-market approval process for new drugs.

While we continue to pursue the development of our cannabinoid-based product candidates, our principal focus is on the development of psychedelic-based treatments.

On May 11, 2022, the Company announced plans to transfer and spin-off its cannabinoid clinical development pipeline assets (the “Spin-Off”) to Akos Biosciences, Inc. (formerly known as Acanna Therapeutics, Inc.), a majority owned subsidiary of the Company (“Akos”). In connection with the Spin-Off, the Company would transfer its cannabinoid clinical development pipeline assets to Akos, while retaining its psychedelics clinical development pipeline assets. The Spin-Off was subject to various conditions, including Akos meeting the qualifications for listing on the Nasdaq Stock Market, and if successful, would result in two standalone public companies.

In May 2023, pursuant to the Akos Series A Preferred Certificate of Designations, the holders of the Akos Series A Preferred Stock exercised their Put Right requiring Akos to redeem all of the outstanding shares of Akos Series A Preferred Stock for $1,000 per share, plus accrued but unpaid dividends of approximately $52,000 for a total redemption amount of approximately $1,052,000. The Company completed the redemption May 19, 2023. The Company now plans to engage with strategic advisors to identify and pursue alternative routes to capture value from the cannabinoid assets.

Recent Developments

Australian Subsidiary

On March 21, 2023, the Company established Enveric Therapeutics, Pty. Ltd. (“Enveric Therapeutics”), an Australia-based subsidiary, to support the Company’s plans to advance its EVM201 Series towards the clinic. Enveric Therapeutics will oversee the Company’s preclinical, clinical, and regulatory activities in Australia, including ongoing interactions with the local Human Research Ethics Committees (HREC) and the Therapeutic Goods Administration (“TGA”), Australia’s regulatory authority.

On March 23, 2023, the Company issued a press release announcing the selection of Australian CRO, Avance Clinical, in preparation for Phase 1 Study of EB-373, the Company’s lead candidate targeting the treatment of anxiety disorders. Under the agreement, Avance Clinical will manage the Phase 1 clinical trial of EB-373 in coordination with the Company’s newly established Australian subsidiary, Enveric Therapeutics Pty, Ltd. The Phase 1 clinical trial is designed as a multi-cohort, dose-ascending study to measure the safety and tolerability of EB-373. EB-373, a next-generation proprietary psilocin prodrug, has been recognized as a New Chemical Entity (NCE) by Australia’s TGA and is currently in preclinical development targeting the treatment of anxiety disorder. The total cost of the Avance Clinical contract is approximately 3,000,000 AUD, which translates to approximately $2,000,000 as of September 30, 2023. As of September 30, 2023, the Company has paid $950,997 of the Avance Clinical contract costs and has $549,713 recorded as prepaid assets. For the three and nine months ended September 30, 2023, the Company has expensed $157,117 and $401,284 in research and development expenses, respectively.

Reduction in Force/Restructuring

On June 16, 2023, the Company entered into a separation agreement with Avani Kanubaddi, the Company’s President and Chief Operating Officer (the “Kanubaddi Separation Agreement”). In accordance with the Kanubaddi Separation Agreement, Mr. Kanubaddi’s outstanding RSUs will retain their vesting conditions. Mr. Kanubaddi’s 2023 salary and benefits of $550,974 was accrued and will be paid out in twelve equal monthly installments beginning in July 2023. Upon termination, any unvested time-based RSU’s became fully vested. The Company accelerated expense recognized related to these shares that vested upon termination of $231,273. Of the 11,278 market performance-based RSUs, 3,759 will continue to be subject to the original terms and conditions of Mr. Kanubaddi’s employment agreement and the remainder were forfeited.

Equity Distribution Agreement

During the three and nine months ended September 30, 2023, the Company has issued no shares of common stock through the Distribution Agreement.

Results of Operations

The following table sets forth information comparing the components of net loss for the three months ended September 30, 2023, and 2022:

	For the Three Months Ended September 30,
	2023			2022
Operating expenses
General and administrative	$	2,010,349		$	3,514,547
Research and development		1,351,750			2,055,656
Depreciation and amortization		86,296			86,646
Total operating expenses		3,448,395			5,656,849

Loss from operations		(3,448,395	)		(5,656,849	)

Other income (expense)
Change in fair value of warrant liabilities		67,822			1,599,623
Change in fair value of investment option liability		562,715			1,809,622
Change in fair value of derivative liability		—			(231,000	)
Interest income (expense)		2,237			(308	)
Total other income		632,774			3,177,937
Net loss before income taxes	$	(2,815,621	)	$	(2,478,912	)

Income tax expense		(6,595	)		—

Net loss	$	(2,822,216	)	$	(2,478,912	)

General and Administrative Expenses

Our general and administrative expenses decreased to $2,010,349 for the three months ended September 30, 2023 from $3,514,547 for the three months ended September 30, 2022, a decrease of $1,504,198, or 43%. This change was primarily driven by a decrease in transaction expenses from liability classified equity offerings of $704,094, stock based compensation of $329,178, directors and officer insurance of $252,097, and marketing of $201,862.

Research and Development Expenses

Our research and development expense for the three months ended September 30, 2023 was $1,351,750 as compared to $2,055,656 for the three months ended September 30, 2022 with a decrease of $703,906, or approximately 34%. This change was primarily driven by the change in strategy and cost reduction plan resulting in a decrease of payroll and consulting fees of $804,023, scientific advisory board fees of $41,198 and product development expense of $151,989, offset by the increase of the Avance clinical contract of $290,797.

Depreciation and Amortization Expense

Depreciation and amortization expense for the three months ended September 30, 2023 was $86,296 as compared to $86,646 for the three months ended September 30, 2022, with a decrease of $350. Depreciation and amortization expense was substantially similar for the three months ended September 30, 2023 compared with the three months ended September 30, 2022.

Change in Fair Value of Warrant Liabilities

Change in fair value of warrant liabilities for the three months ended September 30, 2023 resulted in income of $67,822 as compared to income of $1,599,623 for the three months ended September 30, 2022. The change in fair value of warrant liabilities is significantly influenced by the change in the closing price of Common Stock at the end of each period, as compared to the closing price of Common Stock at the beginning of each period with a strong inverse relationship between changes in fair value of warrant liabilities and the trading price of Common Stock. The Company’s stock price was $2.38 as of September 30, 2023, $3.37 as of June 30, 2023, $4.22 as of September 30, 2022 and $10.70 as of June 30, 2022. The stock price of the Company decreased approximately 29% during the three months ended September 30, 2023 compared to a decrease of approximately 61% during the three months ended September 30, 2022. The significant percentage change in the Company’s stock price during the three months ended September 30, 2023 compared to the three months ended September 30, 2022, resulted in the increase to the change in fair value of warrant liabilities.

Change in Fair Value of Investment Option Liability

Change in fair value of investment option liability for the three months ended September 30, 2023 resulted in income of $562,715, as compared to $1,809,622 during the three months ended September 30, 2022. The change in fair value is due to the significant decrease in the Company’s stock price for the three months ended September 30, 2023. The Company’s stock price was $2.38 on September 30, 2023 and $3.37 on June 30, 2023, a decrease of approximately 29% during that time compared to a decrease of approximately 33% during the three months ended September 30, 2022.

Change in Fair Value of Derivative Liability

The Company’s change in fair value of derivative liability expense was $231,000 for the three months ended September 30, 2022, compared to $0 for the three months ended September 30, 2023 due to redemption of the redeemable stock in May 2023 and therefore no probability of occurrence of the Akos spin-off as of September 30, 2023 as compared to June 30, 2023.

The following table sets forth information comparing the components of net loss for the nine months ended September 30, 2023 and 2022:

	For the Nine Months Ended September 30,
	2023			2022
Operating expenses
General and administrative	$	7,921,340		$	8,783,619
Research and development		5,883,440			6,134,421
Depreciation and amortization		259,300			241,413
Total operating expenses		14,064,080			15,159,453

Loss from operations		(14,064,080	)		(15,159,453	)

Other income (expense)
Change in fair value of warrant liabilities		(115,342	)		3,845,514
Change in fair value of investment option liability		(399,921	)		1,809,622
Change in fair value of derivative liability		727,000			(284,000	)
Interest income (expense)		3,142			(5,114	)
Total other income		214,879			5,366,022

Net loss before income taxes	$	(13,849,201	)	$	(9,793,431	)
Income tax expense		(6,595	)		—
Net loss	$	(13,855,796	)	$	(9,793,431	)

General and Administrative Expenses

Our general and administrative expenses decreased to $7,921,340 for the nine months ended September 30, 2023 from $8,783,619 for the nine months ended September 30, 2022, a decrease of $862,279, or 10%. This change was primarily driven by a decrease in transaction expenses from liability classified equity offerings of $823,970, directors and officers insurance of $780,797, stock based compensation of $202,908 and marketing of $274,814, partially offset by an increase in consulting fees of $626,382, accounting fees of $310,797 and franchise taxes of $307,644.

Research and Development Expenses

Our research and development expense for the nine months ended September 30, 2023 was $5,883,440 as compared to $6,134,421 for the nine months ended September 30, 2022 with a decrease of $250,981, or approximately 4%. This change was primarily driven by increase of the Avance clinical contract of $646,029 and product development of $141,085 offset by payroll and consulting fees of $1,021,851 for the change in strategy and reduction in workforce as part of the cost reduction plan.

Depreciation and Amortization Expense

Depreciation and amortization expense for the nine months ended September 30, 2023 was $259,300 as compared to $241,413 for the nine months ended September 30, 2022, with an increase of $17,887, or approximately 7%. This increase is due to fixed asset additions during the nine months ended September 30, 2022 which only incurred partial depreciation, compared to a full nine months’ of depreciation during the nine months ended September 30, 2023.

Change in Fair Value of Warrant Liabilities

Change in fair value of warrant liabilities the nine months ended September 30, 2023 resulted in expense of $115,342 as compared to income of $3,845,514 for the nine months ended September 30, 2022. The change in fair value of warrant liabilities is significantly influenced by the change in the closing price of Common Stock at the end of each period, as compared to the closing price of Common Stock at the beginning of each period with a strong inverse relationship between changes in fair value of warrant liabilities and the trading price of Common Stock. The Company’s stock price per share was $2.38 as of September 30, 2023, $2.08 as of December 31, 2022, $4.22 as of September 30, 2022 and $46.50 as of December 31, 2021. The stock price of the Company increased approximately 14% during the nine months ended September 30, 2023 compared to a decrease of approximately 91% during the nine months ended September 30, 2022. The significant percentage change in the Company’s stock price during the nine months ended September 30, 2023 compared to the nine months ended September 30, 2022, resulted in the increase to the change in fair value of warrant liabilities.

Change in Fair Value of Investment Option Liability

Change in fair value of investment option liability during the nine months ended September 30, 2023 resulted in expense of $399,921, as compared to $1,809,622 during the nine months ended September 30, 2022. The change in fair value is due to the significant increase in the Company’s stock price the nine months ended September 30, 2023. The Company’s stock price per share was $2.08 on December 31, 2022 and $2.38 on September 30, 2023, an increase of approximately 14% during that time, compared to a decrease of approximately 33% during the nine months ended September 30, 2022. The significant percentage change in the Company’s stock price during the nine months ended September 30, 2023 compared to the nine months ended September 30, 2022, resulted in the increase to the change in fair value of warrant liabilities.

Change in Fair Value of Derivative Liability

The Company’s change in fair value of derivative liability was expense of $284,000 for the nine months ended September 30, 2022 compared to income of $727,000 for the nine months ended September 30, 2023, due primarily to the May 2023 redemption which ceased the probability of occurrence of the Akos spin-off and Akos Series A Preferred Stock redemption as of September 30, 2023 as compared to December 31, 2022.

Going Concern, Liquidity and Capital Resources

The Company has incurred a loss since inception resulting in an accumulated deficit of $93,063,582 as of September 30, 2023 and further losses are anticipated in the development of its business. Further, the Company had operating cash outflows of $12,343,363 for the nine months ended September 30, 2023. For the nine months ended September 30, 2023, the Company had a loss from operations of $14,064,080. Since inception, being a research and development company, the Company has not yet generated revenue and the Company has incurred continuing losses from its operations. The Company’s operations have been funded principally through the issuance of debt and equity. These factors raise substantial doubt about the Company’s ability to continue as a going concern for a period of one year from the issuance of these financial statements.

In assessing the Company’s ability to continue as a going concern, the Company monitors and analyzes its cash and its ability to generate sufficient cash flow in the future to support its operating and capital expenditure commitments. At September 30, 2023, the Company had cash of $4,266,568 and working capital of $1,643,374. The Company’s current cash on hand is insufficient enough to satisfy its operating cash needs for the 12 months following the filing of this Quarterly Report on Form 10-Q. These conditions raise substantial doubt regarding the Company’s ability to continue as a going concern for a period of one year after the date the financial statements are issued. Management’s plan to alleviate the conditions that raise substantial doubt include reducing the Company’s rate of spend, managing its cash flow, advancing its programs, and raising additional working capital through public or private equity or debt financings or other sources, which has included the Equity Distribution Agreement with Canaccord for proceeds of up to $2.4 million and the Purchase Agreement with Lincoln Park, which may include collaborations with third parties as well as disciplined cash spending, to increase the Company’s cash runway. Adequate additional financing may not be available to the Company on acceptable terms, or at all. Should the Company be unable to raise sufficient additional capital, the Company may be required to undertake cost-cutting measures including delaying or discontinuing certain operating activities.

In May 2023, the Company entered into a cost reduction plan, including a reduction in force of approximately 35% of its full-time employees to streamline its operations and conserve cash resources. Additionally, contracts with seven consultants that were focused on the Akos cannabinoid spin-out will be terminated. Additionally, on June 16, 2023, the Company entered into the Kanubaddi Separation Agreement with Avani Kanubaddi, the Company’s President and Chief Operating Officer. In accordance with the Kanubaddi Separation Agreement, Mr. Kanubaddi’s outstanding RSUs will retain their vesting conditions. Mr. Kanubaddi’s 2023 salary and benefits was accrued and will be paid out in twelve equal monthly installments beginning in July 2023. The Company recognized severance charges of approximately $1,004,033 through September 30, 2023, with $396,431 of these charges paid as of September 30, 2023. The plan included a focus on progressing the Company’s existing non-cannabinoid pipeline while reducing the rate of spend and managing cash flow. As of September 30, 2023, the Company has completed the reduction in force, with such severance expenses recorded in salaries and wages and legal accounts.

As a result of these factors, management has concluded that there is substantial doubt about the Company’s ability to continue as a going concern for a period of one year after the date of the financial statements are issued. The Company’s condensed consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

Cash Flows

Since inception, we have primarily used our available cash to fund our product development and operations expenditures.

Cash Flows for the Nine Months Ended September 30, 2023 and 2022

The following table sets forth a summary of cash flows for the years presented:

	For the Nine Months Ended September 30,
	2023			2022
Net cash used in operating activities	$	(12,343,363	)	$	(13,684,606	)
Net cash provided by (used in) investing activities		11,705			(577,972	)
Net cash (used in) provided by financing activities		(1,157,057	)		18,180,138
Effect of foreign exchange rate on cash		31,399			(72,554	)
Net (decrease) increase in cash	$	(13,457,316	)	$	3,845,006

Operating Activities

Net cash used in operating activities was $12,343,363 during the nine months ended September 30, 2023, which consisted primarily of a net loss adjusted for non-cash items of $11,962,774, an increase in prepaid expenses of $746,033, and an increase in accounts payable and accrued liabilities of $429,688.

Net cash used in operating activities was $13,684,606 during the nine months ended September 30, 2022, which consisted primarily of a net loss adjusted for non-cash items of $12,728,490, increase in prepaid expenses and other current assets of $758,419, and a decrease in accounts payable and accrued liabilities of $106,675.

Investing Activities

Net cash provided by investing activities was $11,705 during the nine months ended September 30, 2023, which consisted of the purchase of property and equipment, offset by proceeds from sale of property and equipment.

Net cash used in investing activities was $577,972 during the nine months ended September 30, 2022, which consisted of the purchase of property and equipment.

Financing Activities

Net cash used in financing activities was $1,157,057 during the nine months ended September 30, 2023, which consisted of the redemption of redeemable non-controlling interest and payment of deferred offering costs.

Net cash provided by financing activities was $18,180,138 during the nine months ended September 30, 2022, which consisted of $17,222,100 in proceeds from the sale of common stock and warrants and $958,038 in proceeds from the sale of redeemable non-controlling interest.

Critical Accounting Policies and Significant Judgments and Estimates

The Company’s accounting policies are fundamental to understanding its management’s discussion and analysis. The Company’s significant accounting policies are presented in Note 2 to its financial statements for the year ended December 31, 2022, and included in the Annual Report. The Company’s financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information. Accordingly, they do not include all of the information and notes required by U.S. GAAP. However, in the opinion of the management of the Company, all adjustments necessary for a fair presentation of the financial position and operating results have been included in the Company’s unaudited condensed consolidated financial statements.

Item 3. Quantitative and Qualitative Disclosures About Market Risk

From inception through September 30, 2023, the Company’s reporting currency is the United States dollar while the functional currency of certain of the Company’s subsidiaries were the Canadian dollar and Australian dollar. For the reporting periods ended September 30, 2023 and September 30, 2022, the Company engaged in a number of transactions denominated in Canadian dollars and Australian dollars. As a result, the Company is subject to exposure from changes in the exchange rates of the Canadian dollar and Australian dollar against the U.S. dollar.

Item 4. Controls and Procedures

Evaluation of Disclosure Controls and Procedures

We maintain disclosure controls and procedures designed to ensure that the information we are required to disclose in reports we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified under the rules and forms of the SEC. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that such information is accumulated and communicated to our management, including our Chief Executive Officer and our Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosures. A material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis. The matters that management identified in our Annual Report for the year ended December 31, 2022, continued to exist and were still considered material weaknesses in our internal control over financial reporting at September 30, 2023.

As required by paragraph (b) of Rules 13a-15 and 15d-15 under the Exchange Act, our Chief Executive Officer (our principal executive) and Chief Financial Officer (our principal financial officer and principal accounting officer) carried out an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures as of September 30, 2023. Based on this evaluation, and in light of the material weaknesses found in our internal controls over financial reporting, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures (as defined in paragraph (e) of Rules 13a-15 and 15d-15 under the Exchange Act) were not effective as of September 30, 2023.

Management’s Remediation Plan

As previously discussed in our Annual Report for the year ended December 31, 2022, management had concluded that our internal control over financial reporting was not effective as of December 31, 2022, because management identified inadequate segregation of duties to ensure the processing, review, and authorization of all transactions, including non-routine transactions resulting in deficiencies, which, in aggregate, amounted to a material weakness in the Company’s internal control over financial reporting.

As of September 30, 2023, there were control deficiencies that constituted a material weakness in our internal control over financial reporting. Management has taken, and is taking steps to strengthen our internal control over financial reporting: we have conducted evaluation of the material weakness to determine the appropriate remedy and have established procedures for documenting disclosures and disclosure controls.

While we have taken certain actions to address the material weaknesses identified, additional measures may be necessary as we work to improve the overall effectiveness of our internal controls over financial reporting.

Changes in Internal Control over Financial Reporting

Other than the changes discussed above in the Remediation Plan, there have been no other changes in our internal controls over financial reporting (as defined in Rule 13a-15(f) and 15d-(f) of the Exchange Act) that occurred during quarter ending September 30, 2023, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

PART II. OTHER INFORMATION

Item 1. Legal Proceedings

The Company is periodically involved in legal proceedings, legal actions and claims arising in the ordinary course of business. Other than as described below, we do not have any pending litigation that, separately or in the aggregate, would, in the opinion of management, have a material adverse effect on our financial position, results of operations or cash flows.

Item 1A. Risk Factors

Factors that could cause our actual results to differ materially from those in this Quarterly Report are any of the risks described in the Company’s annual report on Form 10-K as filed with the SEC on March 31, 2023, as amended on June 9, 2023 and quarterly reports on Form 10-Q as filed with the SEC on May 15, 2023 and August 11, 2023. Any of these factors could result in a significant or material adverse effect on our results of operations of financial condition. Additional risk factors not presently known to us or that we currently deem immaterial may also impair our business or results of operations. As of the date of this Quarterly Report, there have been no material changes to the risk factors disclosed in the Company’s annual report on Form 10-K as filed with the SEC on March 31, 2023, as amended on June 9, 2023 and quarterly reports on Form 10-Q as filed with the SEC on May 15, 2023 and August 11, 2023.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

None.

Item 3. Defaults Upon Senior Securities

None.

Item 4. Mine Safety Disclosures

Not applicable.

Item 5. Other Information

The Company, Akos, and the Akos Investor intend to terminate the Akos Purchase Agreement in connection with the planned Spin-Off and that certain registration rights agreement in connection with the Akos Private Placement.

Item 6. Exhibits

INDEX TO EXHIBITS

Exhibit No.		Description

10.1		Equity Distribution Agreement, dated as of September 1, 2023, by and between Enveric Biosciences, Inc. and Cannacord Genuity LLC (incorporated by reference to Exhibit 1.1 to the Company’s Current Report on Form 8-K, filed with the Commission on September 1, 2023)
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*
32.1**		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 (formatted as Inline XBRL document and contained in Exhibit 101)
*		Filed herewith.
**		Furnished herewith.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

	ENVERIC BIOSCIENCES, INC
November 13, 2023
	By:	/s/ Dr. Joseph Tucker
		Dr. Joseph Tucker
		Chief Executive Officer
		(Principal Executive Officer)

November 13, 2023
	By:	/s/ Kevin Coveney
		Kevin Coveney
		Chief Financial Officer
		(Principal Financial and Accounting Officer)

EXHIBIT 31.1

CERTIFICATION PURSUANT to Exchange Act Rule 13a-14(a)/15d-14(a) as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

I, Dr. Joseph Tucker, Chief Executive Officer of Enveric Biosciences, Inc., certify that:

1. I have reviewed this report on Form 10-Q of Enveric Biosciences, Inc. (the “registrant”);

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: November 13, 2023	/s/ Dr. Joseph Tucker
	Dr. Joseph Tucker
	Chief Executive Officer

EXHIBIT 31.2

CERTIFICATION PURSUANT to Exchange Act Rule 13a-14(a)/15d-14(a) as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

I, Kevin Coveney, Chief Financial Officer of Enveric Biosciences, Inc., certify that:

1. I have reviewed this report on Form 10-Q of Enveric Biosciences, Inc. (the “registrant”);

b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: November 13, 2023	/s/ Kevin Coveney
	Kevin Coveney
	Chief Financial Officer

EXHIBIT 32.1

CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350,

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

In connection with the Quarterly Report of Enveric Biosciences, Inc. (the “Issuer”) on Form 10-Q for the period ended September 30, 2023, as filed with the Securities and Exchange Commission on the date hereof (the “Form 10-Q”), each of the undersigned, in the capacities and on the dates indicated below, hereby certifies pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:

(i) the Form 10-Q fully complies with the requirements of Section 13(a) or Section 15(d) of the Securities Exchange Act of 1934; and

(ii) the information contained in the Form 10-Q fairly presents, in all material respects, the financial condition and results of operations of the Issuer.

Dated: November 13, 2023

	By:	/s/ Dr. Joseph Tucker
		Dr. Joseph Tucker
		Chief Executive Officer
		(Principal Executive Officer)

	By:	/s/ Kevin Coveney
		Kevin Coveney
		Chief Financial Officer
		(Principal Financial and Accounting Officer)

Cover - shares	9 Months Ended
Cover - shares	Sep. 30, 2023	Nov. 09, 2023
Cover [Abstract]
Document Type	10-Q
Amendment Flag	false
Document Quarterly Report	true
Document Transition Report	false
Document Period End Date	Sep. 30, 2023
Document Fiscal Period Focus	Q3
Document Fiscal Year Focus	2023
Current Fiscal Year End Date	--12-31
Entity File Number	001-38286
Entity Registrant Name	ENVERIC BIOSCIENCES, INC.
Entity Central Index Key	0000890821
Entity Tax Identification Number	95-4484725
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	4851 Tamiami Trail N
Entity Address, Address Line Two	Suite 200
Entity Address, City or Town	Naples
Entity Address, State or Province	FL
Entity Address, Postal Zip Code	34103
City Area Code	(239)
Local Phone Number	302-1707
Title of 12(b) Security	Common Stock, $0.01 par value per share
Trading Symbol	ENVB
Security Exchange Name	NASDAQ
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		2,321,315

Condensed Consolidated Balance Sheets - USD ($)	Sep. 30, 2023	Dec. 31, 2022
Current assets:
Cash	$ 4,266,568	$ 17,723,884
Prepaid expenses and other current assets	1,560,354	708,053
Total current assets	5,826,922	18,431,937
Other assets:
Property and equipment, net	539,152	677,485
Right-of-use operating lease asset		63,817
Intangible assets, net	253,120	379,686
Total other assets	792,272	1,120,988
Total assets	6,619,194	19,552,925
Current liabilities:
Accounts payable	1,098,233	463,275
Accrued liabilities	1,533,829	1,705,655
Current portion of right-of-use operating lease obligation		63,820
Investment option liability	1,250,929	851,008
Warrant liability	300,557	185,215
Derivative liability		727,000
Total current liabilities	4,183,548	3,995,973
Commitments and contingencies (Note 9)
Mezzanine equity
Series C redeemable preferred stock, $0.01 par value, 100,000 shares authorized, and 0 shares issued and outstanding as of September 30, 2023 and December 31, 2022
Redeemable non-controlling interest		885,028
Total mezzanine equity		885,028
Shareholders’ equity
Preferred stock, $0.01 par value, 20,000,000 shares authorized; Series B preferred stock, $0.01 par value, 3,600,000 shares authorized, 0 shares issued and outstanding as of September 30, 2023 and December 31, 2022
Common stock, $0.01 par value, 100,000,000 shares authorized, 2,181,912 and 2,078,271 shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively	21,818	20,782
Additional paid-in capital	96,013,029	94,395,662
Accumulated deficit	(93,063,582)	(79,207,786)
Accumulated other comprehensive loss	(535,619)	(536,734)
Total shareholders’ equity	2,435,646	14,671,924
Total liabilities, mezzanine equity, and shareholders’ equity	$ 6,619,194	$ 19,552,925

Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares	Sep. 30, 2023	Dec. 31, 2022
Preferred stock, par value	$ 0.01	$ 0.01
Preferred stock, shares authorized	20,000,000	20,000,000
Common stock, par value	$ 0.01	$ 0.01
Common stock, shares authorized	100,000,000	100,000,000
Common stock, shares issued	2,181,912	2,078,271
Common stock, shares outstanding	2,181,912	2,078,271
Series B Preferred Stock [Member]
Preferred stock, par value	$ 0.01	$ 0.01
Preferred stock, shares authorized	3,600,000	3,600,000
Preferred stock, shares issued	0	0
Preferred stock, shares outstanding	0	0
Series C Redeemable Preferred Stock [Member]
Temporary equity, par value	$ 0.01	$ 0.01
Temporary equity, shares authorized	100,000	100,000
Temporary equity, shares issued	0	0
Temporary equity, shares outstanding	0	0

Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Operating expenses
General and administrative	$ 2,010,349	$ 3,514,547	$ 7,921,340	$ 8,783,619
Research and development	1,351,750	2,055,656	5,883,440	6,134,421
Depreciation and amortization	86,296	86,646	259,300	241,413
Total operating expenses	3,448,395	5,656,849	14,064,080	15,159,453
Loss from operations	(3,448,395)	(5,656,849)	(14,064,080)	(15,159,453)
Other income (expense)
Change in fair value of warrant liabilities	67,822	1,599,623	(115,342)	3,845,514
Change in fair value of investment option liability	562,715	1,809,622	(399,921)	1,809,622
Change in fair value of derivative liability		(231,000)	727,000	(284,000)
Interest income (expense)	2,237	(308)	3,142	(5,114)
Total other income	632,774	3,177,937	214,879	5,366,022
Net loss before income taxes	(2,815,621)	(2,478,912)	(13,849,201)	(9,793,431)
Income tax expense	(6,595)		(6,595)
Net loss	(2,822,216)	(2,478,912)	(13,855,796)	(9,793,431)
Less preferred dividends attributable to non-controlling interest		12,603	19,041	20,411
Less deemed dividends attributable to accretion of embedded derivative at redemption value		110,991	147,988	184,985
Net loss attributable to shareholders	(2,822,216)	(2,602,506)	(14,022,825)	(9,998,827)
Other comprehensive loss
Foreign currency translation	10,433	(417,390)	1,115	(609,695)
Comprehensive loss	$ (2,811,783)	$ (3,019,896)	$ (14,021,710)	$ (10,608,522)
Net loss per share - basic	$ (1.30)	$ (1.46)	$ (6.62)	$ (8.11)
Net loss per share - diluted	$ (1.30)	$ (1.46)	$ (6.62)	$ (8.11)
Weighted average shares outstanding, basic	2,164,656	1,787,235	2,117,153	1,232,936
Weighted average shares outstanding, diluted	2,164,656	1,787,235	2,117,153	1,232,936

Condensed Consolidated Statements of Changes in Mezzanine Equity and Shareholders' Equity (Unaudited) - USD ($)	Series C Redeemable Preferred Stock [Member]	Redeemable Noncontrolling Interest [Member]	Mezzanine Equity [Member]	Common Stock [Member]	Additional Paid-in Capital [Member]	Retained Earnings [Member]	AOCI Attributable to Parent [Member]	Total
Balance at Dec. 31, 2021				$ 6,519	$ 83,066,656	$ (60,736,453)	$ (30,802)	$ 22,305,920
Mezzanine equity beginning balance, shares at Dec. 31, 2021
Beginning balance, shares at Dec. 31, 2021				651,921
Stock-based compensation					768,619			768,619
Foreign exchange translation loss							88,709	88,709
Net loss						(4,524,014)		(4,524,014)
February 2022 registered direct offering				$ 4,000	5,798,464			5,802,464
February 2022 registered direct offering, shares				400,000
Conversion of RSUs into common shares				$ 9	(9)
Conversion of RSUs into common shares, shares				899
Balance at Mar. 31, 2022				$ 10,528	89,633,730	(65,260,467)	57,907	24,441,698
Mezzanine equity ending balance, shares at Mar. 31, 2022
Ending balance, shares at Mar. 31, 2022				1,052,820
Balance at Dec. 31, 2021				$ 6,519	83,066,656	(60,736,453)	(30,802)	22,305,920
Mezzanine equity beginning balance, shares at Dec. 31, 2021
Beginning balance, shares at Dec. 31, 2021				651,921
Preferred dividends attributable to redeemable non-controlling interest								(20,411)
Accretion of embedded derivatives to redemption value								(184,985)
Foreign exchange translation loss								(609,695)
Net loss								(9,793,431)
Issuance of common shares in exchange for RSU conversions, shares				2,122
Balance at Sep. 30, 2022		$ 761,434	761,434	$ 20,782	93,989,885	(70,529,884)	(640,497)	22,840,286
Mezzanine equity ending balance, shares at Sep. 30, 2022		1,000
Ending balance, shares at Sep. 30, 2022				2,078,271
Balance at Mar. 31, 2022				$ 10,528	89,633,730	(65,260,467)	57,907	24,441,698
Mezzanine equity beginning balance, shares at Mar. 31, 2022
Beginning balance, shares at Mar. 31, 2022				1,052,820
Stock-based compensation					677,543			677,543
Preferred dividends attributable to redeemable non-controlling interest		7,808	7,808		(7,808)			(7,808)
Accretion of embedded derivatives to redemption value		73,994	73,994		(73,994)			(73,994)
Foreign exchange translation loss							(281,014)	(281,014)
Net loss						(2,790,505)		(2,790,505)
Redeemable non-controlling interest, net of $402,000 embedded derivative and net of issuance costs of $41,962		$ 556,038	556,038
Redeemable non-controlling interest, shares		1,000
Issuance of redeemable non-controlling Series C preferred stock	$ 527		527		(527)			(527)
Issuance of redeemable non-controlling Series C preferred stock, shares	52,685
Conversion of RSAs into common shares				$ 12	(12)
Conversion of RSAs into common shares, shares				1,223
Balance at Jun. 30, 2022	$ 527	$ 637,840	638,367	$ 10,540	90,228,932	(68,050,972)	(223,107)	21,965,393
Mezzanine equity ending balance, shares at Jun. 30, 2022	52,685	1,000
Ending balance, shares at Jun. 30, 2022				1,054,043
Stock-based compensation					645,137			645,137
Preferred dividends attributable to redeemable non-controlling interest		12,603	12,603		(12,603)			(12,603)
Accretion of embedded derivatives to redemption value		110,991	110,991		(110,991)			(110,991)
Foreign exchange translation loss							(417,390)	(417,390)
Net loss						(2,478,912)		(2,478,912)
Redemption of Series C preferred stock	(527)		(527)		527			527
Redemption of Series C preferred stock, shares		(52,685)
July 2022 registered direct offering, PIPE offering, modification of warrants and exercise of pre-funded warrants, net of offering costs				$ 10,000	3,239,125			3,249,125
July 2022 registered direct offering, PIPE offering, modification of warrants and exercise of pre-funded warrants, net of offering costs, shares				1,000,000
Issuance of rounded shares as a result of the reverse stock split				$ 242	(242)
Issuance of rounded shares as a result of the reverse stock split, shares				24,228
Balance at Sep. 30, 2022		$ 761,434	761,434	$ 20,782	93,989,885	(70,529,884)	(640,497)	22,840,286
Mezzanine equity ending balance, shares at Sep. 30, 2022		1,000
Ending balance, shares at Sep. 30, 2022				2,078,271
Balance at Dec. 31, 2022		$ 885,028	885,028	$ 20,782	94,395,662	(79,207,786)	(536,734)	14,671,924
Mezzanine equity beginning balance, shares at Dec. 31, 2022		1,000
Beginning balance, shares at Dec. 31, 2022				2,078,271
Stock-based compensation					532,835			532,835
Preferred dividends attributable to redeemable non-controlling interest		12,329	12,329		(12,329)			(12,329)
Accretion of embedded derivatives to redemption value		110,991	110,991		(110,991)			(110,991)
Foreign exchange translation loss							1,968	1,968
Net loss						(4,677,527)		(4,677,527)
Balance at Mar. 31, 2023		$ 1,008,348	1,008,348	$ 20,782	94,805,177	(83,885,313)	(534,766)	10,405,880
Mezzanine equity ending balance, shares at Mar. 31, 2023		1,000
Ending balance, shares at Mar. 31, 2023				2,078,271
Balance at Dec. 31, 2022		$ 885,028	885,028	$ 20,782	94,395,662	(79,207,786)	(536,734)	14,671,924
Mezzanine equity beginning balance, shares at Dec. 31, 2022		1,000
Beginning balance, shares at Dec. 31, 2022				2,078,271
Preferred dividends attributable to redeemable non-controlling interest								(19,041)
Accretion of embedded derivatives to redemption value								(147,988)
Foreign exchange translation loss								1,115
Net loss								(13,855,796)
Issuance of common shares in exchange for RSU conversions, shares				103,641
Balance at Sep. 30, 2023				$ 21,818	96,013,029	(93,063,582)	(535,619)	2,435,646
Mezzanine equity ending balance, shares at Sep. 30, 2023
Ending balance, shares at Sep. 30, 2023				2,181,912
Balance at Mar. 31, 2023		$ 1,008,348	1,008,348	$ 20,782	94,805,177	(83,885,313)	(534,766)	10,405,880
Mezzanine equity beginning balance, shares at Mar. 31, 2023		1,000
Beginning balance, shares at Mar. 31, 2023				2,078,271
Stock-based compensation					879,738			879,738
Preferred dividends attributable to redeemable non-controlling interest		6,712	6,712		(6,712)			(6,712)
Accretion of embedded derivatives to redemption value		36,997	36,997		(36,997)			(36,997)
Foreign exchange translation loss							(11,286)	(11,286)
Net loss						(6,356,053)		(6,356,053)
Redemption of Series C preferred stock		$ (1,052,057)	(1,052,057)
Redemption of Series C preferred stock, shares		(1,000)
Issuance of common shares in exchange for RSU conversions				$ 635	(635)
Issuance of common shares in exchange for RSU conversions, shares				63,511
Balance at Jun. 30, 2023				$ 21,417	95,640,571	(90,241,366)	(546,052)	4,874,570
Mezzanine equity ending balance, shares at Jun. 30, 2023
Ending balance, shares at Jun. 30, 2023				2,141,782
Stock-based compensation					372,859			372,859
Foreign exchange translation loss							10,433	10,433
Net loss						(2,822,216)		(2,822,216)
Issuance of common shares in exchange for RSU conversions				$ 401	(401)
Issuance of common shares in exchange for RSU conversions, shares				40,130
Balance at Sep. 30, 2023				$ 21,818	$ 96,013,029	$ (93,063,582)	$ (535,619)	$ 2,435,646
Mezzanine equity ending balance, shares at Sep. 30, 2023
Ending balance, shares at Sep. 30, 2023				2,181,912

Condensed Consolidated Statements of Changes in Mezzanine Equity and Shareholders' Equity (Unaudited) (Parenthetical)	3 Months Ended
	Jun. 30, 2022 USD ($)
Statement of Stockholders' Equity [Abstract]
Redeemable noncontrolling interest embedded derivative	$ 402,000
Redeemable noncontrolling interest issuance costs	$ 41,962

Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($)	3 Months Ended	9 Months Ended
	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Cash Flows From Operating Activities:
Net loss	$ (2,478,912)	$ (13,855,796)	$ (9,793,431)
Adjustments to reconcile net loss to cash used in operating activities
Change in fair value of warrant liability	(1,599,623)	115,342	(3,845,514)
Change in fair value of investment option liability	(1,809,622)	399,921	(1,809,622)
Change in fair value of derivative liability	231,000	(727,000)	284,000
Stock-based compensation		1,785,432	2,091,299
Amortization of right-of-use asset		64,246	103,365
Amortization of intangible assets	42,191	126,566	126,563
Depreciation expense	44,458	132,734	114,850
Gain on disposal of property and equipment		(4,219)
Change in operating assets and liabilities:
Prepaid expenses and other current assets		(746,033)	(758,419)
Accounts payable and accrued liabilities		429,688	(106,675)
Right-of-use operating lease liability		(64,244)	(91,022)
Net cash used in operating activities		(12,343,363)	(13,684,606)
Cash Flows From Investing Activities:
Purchases of property and equipment		(5,195)	(577,972)
Proceeds from disposal of property and equipment		16,900
Net cash provided by (used in) investing activities		11,705	(577,972)
Cash Flows From Financing Activities:
Payment for the deferred offering costs from the equity distribution agreement		(105,000)
Proceeds from sale of common stock, warrants, and investment options, net of offering costs			17,222,100
Redemption of Series A Preferred Stock (see Note 8)		(1,052,057)
Proceeds from the sale of redeemable non-controlling interest, net of offering			958,038
Net cash (used in) provided by financing activities		(1,157,057)	18,180,138
Effect of foreign exchange rate on cash		31,399	(72,554)
Net (decrease) increase in cash		(13,457,316)	3,845,006
Cash at beginning of period		17,723,884	17,355,999
Cash at end of period	21,201,005	4,266,568	21,201,005
Supplemental disclosure of cash and non-cash transactions:
Cash paid for interest			5,114
Income taxes paid		6,595
Warrants issued in conjunction with common stock issuance			3,595,420
Issuance of embedded derivative			402,000
Issuance of redeemable non-controlling Series C preferred stock
Offering costs accrued not paid		20,800
Preferred dividends attributable to redeemable non-controlling interest	12,603	19,041	20,411
Accretion of embedded derivative to redemption value	$ 110,991	147,988	184,985
Investment options issued in conjunction with common stock issuance			4,323,734
Modification of warrants as part of share capital raise			$ 251,357

BUSINESS AND LIQUIDITY AND OTHER UNCERTAINTIES

9 Months Ended

Sep. 30, 2023

Organization, Consolidation and Presentation of Financial Statements [Abstract]

BUSINESS AND LIQUIDITY AND OTHER UNCERTAINTIES

NOTE 1. BUSINESS AND LIQUIDITY AND OTHER UNCERTAINTIES

Nature of Operations

Akos Spin-Off

Australian Subsidiary

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

Going Concern, Liquidity and Other Uncertainties

Reduction in Force/Restructuring

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

SCHEDULE OF RESTRUCTURING COSTS PAYABLE

	Accrued Restructuring Costs
January 1, 2023 Beginning balance	$	—
Restructuring costs incurred		1,004,033
Restructuring costs paid		(396,431	)
September 30, 2023 ending balance	$	607,602

Inflation Risks

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

9 Months Ended

Sep. 30, 2023

Accounting Policies [Abstract]

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

NOTE 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Basis of Presentation and Principal of Consolidation

Use of Estimates

Foreign Currency Translation

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

Concentration of Credit Risk

Deferred Offering Costs

Warrant Liability and Investment Options

Derivative Liability

Income Taxes

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

Net Loss per Share

	For the three and nine months ended September 30, 2023		For the three and nine months ended September 30, 2022
Warrants to purchase shares of common stock		609,893		655,463
Restricted stock units - vested and unissued		20,847		61,428
Restricted stock units - unvested		148,251		65,117
Restricted stock awards - vested and unissued		—		974
Investment options to purchase shares of common stock		1,070,000		1,070,000
Options to purchase shares of common stock		31,852		22,829
Total potentially dilutive securities		1,880,843		1,875,811

Fair Value Measurements

Level 1 - Valuations based on quoted prices for identical assets and liabilities in active markets.

	Level	September 30, 2023		December 31, 2022
Warrant liabilities - January 2021 Warrants	3	$	18	$	81
Warrant liabilities - February 2021 Warrants	3		59		79
Warrant liabilities - February 2022 Warrants	3		300,480		185,055
Fair value of warrant liability		$	300,557	$	185,215

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

	Level	September 30, 2023		December 31, 2022
Derivative liability - May 2022	3	$	—	$	727,000
Fair value of derivative liability		$	—	$	727,000

	Level	September 30, 2023		December 31, 2022
H.C. Wainwright & Co., LLC investment options	3	$	70,521	$	44,904
RD investment options	3		442,653		302,289
PIPE investment options	3		737,755		503,815
Fair value of investment option liability		$	1,250,929	$	851,008

Subsequent measurement

The following table presents the changes in fair value of the warrant liabilities, derivative liability, and investment options that are classified as Level 3:

	Total Warrant Liabilities
Fair value as of December 31, 2022	$	185,215
Change in fair value		115,342
Fair value as of September 30, 2023	$	300,557

	Total Derivative Liability
Fair value as of December 31, 2022	$	727,000
Change in fair value arising from redemption of Akos Series A Preferred Stock - See Note 8		(727,000	)
Fair value of derivative liability as of September 30, 2023	$	—

	Total Investment Option Liability
Fair value as of December 31, 2022	$	851,008
Change in fair value		399,921
Fair value of investment option liability as of September 30, 2023	$	1,250,929

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

The key inputs into the Black Scholes valuation model for the Level 3 valuations of the warrant liabilities as of September 30, 2023 are below:

	January 2021 Warrants			February 2021 Warrants			February 2022 Warrants			February 2022 Post-Modification Warrants
Term (years)		2.3			2.4			3.4			4.3
Stock price	$	2.38		$	2.38		$	2.38		$	2.38
Exercise price	$	247.50		$	245.00		$	27.50		$	7.78
Dividend yield		—	%		—	%		—	%		—	%
Expected volatility		80.0	%		85.0	%		96.0	%		94.0	%
Risk free interest rate		5.00	%		4.90	%		4.80	%		4.70	%
Number of warrants		36,429			34,281			338,000			122,000
Value (per share)	$	—		$	—		$	0.46		$	1.18

The key inputs into the Black Scholes valuation model for the Level 3 valuations of the investment options as of September 30, 2023 are below:

	H.C. Wainwright & Co., LLC Options			RD Offering Options			PIPE Offering Options
Term (years)		3.8			4.3			4.3
Stock price	$	2.38		$	2.38		$	2.38
Exercise price	$	10.00		$	7.78		$	7.78
Dividend yield		—	%		—	%		—	%
Expected volatility		97.0	%		94.0	%		94.0	%
Risk free interest rate		4.70	%		4.70	%		4.70	%
Number of investment options		70,000			375,000			625,000
Value (per share)	$	1.01		$	1.18		$	1.18

The key inputs into the Weighted Expected Return valuation model for the Level 3 valuations of the derivative liability as of redemption, are below:

		May 2022 Derivative Liability
Principal	$	—
Dividend rate		—	%
Market rate		—	%

At the date of the redemption of the of Akos Series A Preferred Stock in May 2023, the derivative liability fair value was $0 due to the probability of a spin-off occurring was zero. See Note 8

Redeemable Non-controlling Interest

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

Segment Reporting

Recent Accounting Pronouncements

PREPAID EXPENSES AND OTHER CURRENT ASSETS

9 Months Ended

Sep. 30, 2023

Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract]

PREPAID EXPENSES AND OTHER CURRENT ASSETS

NOTE 3. PREPAID EXPENSES AND OTHER CURRENT ASSETS

As of September 30, 2023 and December 31, 2022, the prepaid expenses and other current assets of the Company consisted of the following:

	September 30, 2023		December 31, 2022
Prepaid research and development	$	651,623	$	268,686
Prepaid value-added taxes		229,909		159,782
Prepaid professional fees		74,500		—
Prepaid insurance		332,508		174,406
Prepaid other		146,014		105,179
Deferred offering costs		125,800		—
Total prepaid expenses and other current assets	$	1,560,354	$	708,053

INTANGIBLE ASSETS

9 Months Ended

Sep. 30, 2023

Goodwill and Intangible Assets Disclosure [Abstract]

INTANGIBLE ASSETS

NOTE 4. INTANGIBLE ASSETS

As of September 30, 2023, the Company’s intangible assets consisted of:

Definite lived intangible assets
Balance at December 31, 2022	$	379,686
Amortization		(126,566	)
Balance at September 30, 2023	$	253,120

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

PROPERTY AND EQUIPMENT

9 Months Ended

Sep. 30, 2023

Property, Plant and Equipment [Abstract]

PROPERTY AND EQUIPMENT

NOTE 5. PROPERTY AND EQUIPMENT

	September 30, 2023			December 31, 2022
Lab equipment	$	818,460		$	831,123
Computer equipment and leasehold improvements		27,759			25,137
Less: Accumulated depreciation		(307,067	)		(178,775	)
Property and equipment, net of accumulated depreciation	$	539,152		$	677,485

ACCRUED LIABILITIES

9 Months Ended

Sep. 30, 2023

Payables and Accruals [Abstract]

ACCRUED LIABILITIES

NOTE 6. ACCRUED LIABILITIES

As of September 30, 2023 and December 31, 2022, the accrued liabilities of the Company consisted of the following:

SCHEDULE OF ACCRUED LIABILITIES

	September 30, 2023		December 31, 2022
Product development	$	94,663	$	195,104
Accrued salaries and wages		729,616		1,175,963
Professional fees		74,499		83,255
Accrued restructuring costs		607,602		—
Accrued franchise taxes		9,449		—
Patent costs		18,000		251,333
Total accrued expenses	$	1,533,829	$	1,705,655

SHARE CAPITAL AND OTHER EQUITY INSTRUMENTS

9 Months Ended

Sep. 30, 2023

Equity [Abstract]

SHARE CAPITAL AND OTHER EQUITY INSTRUMENTS

NOTE 7. SHARE CAPITAL AND OTHER EQUITY INSTRUMENTS

Authorized Capital

Equity Distribution Agreement

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

Common Stock Activity

Stock Options

Amendment to 2020 Long-Term Incentive Plan

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

A summary of activity under the Company’s incentive plan for the nine months ended September 30, 2023, is presented below:

SCHEDULE OF STOCK OPTION

	Number of Shares			Weighted Average Exercise Price		Weighted Average Grant Date Fair Value		Weighted Average Remaining Contractual Term (years)		Aggregate Intrinsic Value
Outstanding at December 31, 2022		48,329		$	37.05	$	44.82		4.1	$	—
Forfeited		(16,476	)	$	5.79	$	5.80		—	$	—
Outstanding at September 30, 2023		31,852		$	53.18	$	74.04		3.4	$	—
Exercisable at September 30, 2023		24,626		$	63.72	$	86.52		3.0	$	—

Restricted Stock Awards

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

Issuance of Restricted Stock Units

The Company’s activity in restricted stock units was as follows for the nine months ended September 30, 2023:

	Number of shares			Weighted average fair value
Non-vested at December 31, 2022		64,053		$	92.57
Granted		182,500		$	2.73
Vested		(62,636	)	$	19.80
Forfeited		(35,666	)	$	27.45
Non-vested at September 30, 2023		148,251		$	28.39

The following table summarizes the Company’s recognition of stock-based compensation for restricted stock units for the following periods:

	2023		2022		2023		2022
	Three months ended September 30,				Nine months ended September 30,
	2023		2022		2023		2022
Stock-based compensation expense for RSUs:
General and administrative	$	101,607	$	357,756	$	946,851	$	1,138,080
Research and development		226,646		232,434		691,514		794,473
Total	$	328,253	$	590,190	$	1,638,365	$	1,932,553

Warrants

The following table summarizes information about shares issuable under warrants outstanding on September 30, 2023:

SCHEDULE OF WARRANTS OUTSTANDING

	Warrant shares outstanding			Weighted average exercise price		Weighted average remaining life		Intrinsic value
Outstanding at December 31, 2022		655,463		$	58.36		3.6	$	5,514
Expired		(45,570	)	$	111.50		—	$	—
Outstanding at September 30, 2023		609,893		$	50.46		2.9	$	—
Exercisable at September 30, 2023		609,893		$	50.46		2.9	$	—

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

Preferred Investment Options

The following table summarizes information about investment options outstanding on September 30, 2023:

	Investment options outstanding		Weighted average exercise price		Weighted average remaining life		Intrinsic value
Outstanding at December 31, 2022		1,070,000	$	7.93		5.1	$	—
Outstanding at September 30, 2023		1,070,000	$	7.93		4.3	$	—
Exercisable at September 30, 2023		1,070,000	$	7.93		4.3	$	—

REDEEMABLE NON-CONTROLLING INTEREST

9 Months Ended

Sep. 30, 2023

Redeemable Non-controlling Interest

REDEEMABLE NON-CONTROLLING INTEREST

NOTE 8. REDEEMABLE NON-CONTROLLING INTEREST

Spin-Off and Related Private Placement

Terms of Akos Series A Preferred Stock

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

Redemption of Akos Series A Preferred Stock

Accounting for Akos Series A Preferred Stock

The table below presents the reconciliation of changes in redeemable non-controlling interest:

Balance at December 31, 2022	$	885,028
Preferred dividends attributable to redeemable non-controlling interest		19,041
Accretion of embedded derivative and transaction costs associated with Akos Series A Preferred		147,988
Redemption of Akos Series A Preferred Stock		(1,052,057	)
Balance at September 30, 2023	$	—

In May 2023, the Akos Series A Preferred Stock was redeemed for a total of $1,052,057, and the balance of the redeemable non-controlling interest is $0 as of September 30, 2023.

COMMITMENTS AND CONTINGENCIES

9 Months Ended

Sep. 30, 2023

Commitments and Contingencies Disclosure [Abstract]

COMMITMENTS AND CONTINGENCIES

NOTE 9. COMMITMENTS AND CONTINGENCIES

Australian Subsidiary Research and Development

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

Development and Clinical Supply Agreement

The Company has met the minimum purchase requirement of 1 kilogram during the first thirty days of the PureForm Agreement’s effectiveness.

Purchase agreement with Prof. Zvi Vogel and Dr. Ilana Nathan

Other Consulting and Vendor Agreements

SUBSEQUENT EVENTS

9 Months Ended

Sep. 30, 2023

Subsequent Events [Abstract]

SUBSEQUENT EVENTS

NOTE 10. SUBSEQUENT EVENTS

Lincoln Park Equity Line

For additional details, please refer to the Company’s Current Report on Form 8-K filed with the SEC on November 6, 2023.

2020 Long-Term Incentive Plan Amended

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)

9 Months Ended

Sep. 30, 2023

Accounting Policies [Abstract]

Basis of Presentation and Principal of Consolidation

Basis of Presentation and Principal of Consolidation

Use of Estimates

Use of Estimates

Foreign Currency Translation

Foreign Currency Translation

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

Concentration of Credit Risk

Concentration of Credit Risk

Deferred Offering Costs

Deferred Offering Costs

Warrant Liability and Investment Options

Warrant Liability and Investment Options

Derivative Liability

Derivative Liability

Income Taxes

Income Taxes

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

Net Loss per Share

Net Loss per Share

	For the three and nine months ended September 30, 2023		For the three and nine months ended September 30, 2022
Warrants to purchase shares of common stock		609,893		655,463
Restricted stock units - vested and unissued		20,847		61,428
Restricted stock units - unvested		148,251		65,117
Restricted stock awards - vested and unissued		—		974
Investment options to purchase shares of common stock		1,070,000		1,070,000
Options to purchase shares of common stock		31,852		22,829
Total potentially dilutive securities		1,880,843		1,875,811

Fair Value Measurements

Fair Value Measurements

Level 1 - Valuations based on quoted prices for identical assets and liabilities in active markets.

	Level	September 30, 2023		December 31, 2022
Warrant liabilities - January 2021 Warrants	3	$	18	$	81
Warrant liabilities - February 2021 Warrants	3		59		79
Warrant liabilities - February 2022 Warrants	3		300,480		185,055
Fair value of warrant liability		$	300,557	$	185,215

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

	Level	September 30, 2023		December 31, 2022
Derivative liability - May 2022	3	$	—	$	727,000
Fair value of derivative liability		$	—	$	727,000

	Level	September 30, 2023		December 31, 2022
H.C. Wainwright & Co., LLC investment options	3	$	70,521	$	44,904
RD investment options	3		442,653		302,289
PIPE investment options	3		737,755		503,815
Fair value of investment option liability		$	1,250,929	$	851,008

Subsequent measurement

The following table presents the changes in fair value of the warrant liabilities, derivative liability, and investment options that are classified as Level 3:

	Total Warrant Liabilities
Fair value as of December 31, 2022	$	185,215
Change in fair value		115,342
Fair value as of September 30, 2023	$	300,557

	Total Derivative Liability
Fair value as of December 31, 2022	$	727,000
Change in fair value arising from redemption of Akos Series A Preferred Stock - See Note 8		(727,000	)
Fair value of derivative liability as of September 30, 2023	$	—

	Total Investment Option Liability
Fair value as of December 31, 2022	$	851,008
Change in fair value		399,921
Fair value of investment option liability as of September 30, 2023	$	1,250,929

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

The key inputs into the Black Scholes valuation model for the Level 3 valuations of the warrant liabilities as of September 30, 2023 are below:

	January 2021 Warrants			February 2021 Warrants			February 2022 Warrants			February 2022 Post-Modification Warrants
Term (years)		2.3			2.4			3.4			4.3
Stock price	$	2.38		$	2.38		$	2.38		$	2.38
Exercise price	$	247.50		$	245.00		$	27.50		$	7.78
Dividend yield		—	%		—	%		—	%		—	%
Expected volatility		80.0	%		85.0	%		96.0	%		94.0	%
Risk free interest rate		5.00	%		4.90	%		4.80	%		4.70	%
Number of warrants		36,429			34,281			338,000			122,000
Value (per share)	$	—		$	—		$	0.46		$	1.18

The key inputs into the Black Scholes valuation model for the Level 3 valuations of the investment options as of September 30, 2023 are below:

	H.C. Wainwright & Co., LLC Options			RD Offering Options			PIPE Offering Options
Term (years)		3.8			4.3			4.3
Stock price	$	2.38		$	2.38		$	2.38
Exercise price	$	10.00		$	7.78		$	7.78
Dividend yield		—	%		—	%		—	%
Expected volatility		97.0	%		94.0	%		94.0	%
Risk free interest rate		4.70	%		4.70	%		4.70	%
Number of investment options		70,000			375,000			625,000
Value (per share)	$	1.01		$	1.18		$	1.18

The key inputs into the Weighted Expected Return valuation model for the Level 3 valuations of the derivative liability as of redemption, are below:

		May 2022 Derivative Liability
Principal	$	—
Dividend rate		—	%
Market rate		—	%

At the date of the redemption of the of Akos Series A Preferred Stock in May 2023, the derivative liability fair value was $0 due to the probability of a spin-off occurring was zero. See Note 8

Redeemable Non-controlling Interest

Redeemable Non-controlling Interest

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

Segment Reporting

Segment Reporting

Recent Accounting Pronouncements

Recent Accounting Pronouncements

BUSINESS AND LIQUIDITY AND OTHER UNCERTAINTIES (Tables)

9 Months Ended

Sep. 30, 2023

Organization, Consolidation and Presentation of Financial Statements [Abstract]

SCHEDULE OF RESTRUCTURING COSTS PAYABLE

	Accrued Restructuring Costs
January 1, 2023 Beginning balance	$	—
Restructuring costs incurred		1,004,033
Restructuring costs paid		(396,431	)
September 30, 2023 ending balance	$	607,602

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables)

9 Months Ended

Sep. 30, 2023

SCHEDULE OF POTENTIALLY DILUTIVE SECURITIES

	For the three and nine months ended September 30, 2023		For the three and nine months ended September 30, 2022
Warrants to purchase shares of common stock		609,893		655,463
Restricted stock units - vested and unissued		20,847		61,428
Restricted stock units - unvested		148,251		65,117
Restricted stock awards - vested and unissued		—		974
Investment options to purchase shares of common stock		1,070,000		1,070,000
Options to purchase shares of common stock		31,852		22,829
Total potentially dilutive securities		1,880,843		1,875,811

SCHEDULE OF FAIR VALUE HIERARCHY OF VALUATION INPUTS ON RECURRING BASIS

	Level	September 30, 2023		December 31, 2022
Warrant liabilities - January 2021 Warrants	3	$	18	$	81
Warrant liabilities - February 2021 Warrants	3		59		79
Warrant liabilities - February 2022 Warrants	3		300,480		185,055
Fair value of warrant liability		$	300,557	$	185,215

ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

	Level	September 30, 2023		December 31, 2022
Derivative liability - May 2022	3	$	—	$	727,000
Fair value of derivative liability		$	—	$	727,000

	Level	September 30, 2023		December 31, 2022
H.C. Wainwright & Co., LLC investment options	3	$	70,521	$	44,904
RD investment options	3		442,653		302,289
PIPE investment options	3		737,755		503,815
Fair value of investment option liability		$	1,250,929	$	851,008

Subsequent Measurement [Member]

SCHEDULE OF FAIR VALUE OF WARRANT LIABILITIES AND DERIVATIVE LIABILITY AND INVESTMENT OPTIONS

The following table presents the changes in fair value of the warrant liabilities, derivative liability, and investment options that are classified as Level 3:

	Total Warrant Liabilities
Fair value as of December 31, 2022	$	185,215
Change in fair value		115,342
Fair value as of September 30, 2023	$	300,557

	Total Derivative Liability
Fair value as of December 31, 2022	$	727,000
Change in fair value arising from redemption of Akos Series A Preferred Stock - See Note 8		(727,000	)
Fair value of derivative liability as of September 30, 2023	$	—

	Total Investment Option Liability
Fair value as of December 31, 2022	$	851,008
Change in fair value		399,921
Fair value of investment option liability as of September 30, 2023	$	1,250,929

SCHEDULE OF BLACK SCHOLES VALUATION MODELS OF WARRANT LIABILITIES AND INVESTMENT OPTIONS

The key inputs into the Black Scholes valuation model for the Level 3 valuations of the warrant liabilities as of September 30, 2023 are below:

	January 2021 Warrants			February 2021 Warrants			February 2022 Warrants			February 2022 Post-Modification Warrants
Term (years)		2.3			2.4			3.4			4.3
Stock price	$	2.38		$	2.38		$	2.38		$	2.38
Exercise price	$	247.50		$	245.00		$	27.50		$	7.78
Dividend yield		—	%		—	%		—	%		—	%
Expected volatility		80.0	%		85.0	%		96.0	%		94.0	%
Risk free interest rate		5.00	%		4.90	%		4.80	%		4.70	%
Number of warrants		36,429			34,281			338,000			122,000
Value (per share)	$	—		$	—		$	0.46		$	1.18

The key inputs into the Black Scholes valuation model for the Level 3 valuations of the investment options as of September 30, 2023 are below:

	H.C. Wainwright & Co., LLC Options			RD Offering Options			PIPE Offering Options
Term (years)		3.8			4.3			4.3
Stock price	$	2.38		$	2.38		$	2.38
Exercise price	$	10.00		$	7.78		$	7.78
Dividend yield		—	%		—	%		—	%
Expected volatility		97.0	%		94.0	%		94.0	%
Risk free interest rate		4.70	%		4.70	%		4.70	%
Number of investment options		70,000			375,000			625,000
Value (per share)	$	1.01		$	1.18		$	1.18

The key inputs into the Weighted Expected Return valuation model for the Level 3 valuations of the derivative liability as of redemption, are below:

		May 2022 Derivative Liability
Principal	$	—
Dividend rate		—	%
Market rate		—	%

PREPAID EXPENSES AND OTHER CURRENT ASSETS (Tables)

9 Months Ended

Sep. 30, 2023

Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract]

SCHEDULE OF PREPAID EXPENSES AND OTHER CURRENT ASSETS

As of September 30, 2023 and December 31, 2022, the prepaid expenses and other current assets of the Company consisted of the following:

	September 30, 2023		December 31, 2022
Prepaid research and development	$	651,623	$	268,686
Prepaid value-added taxes		229,909		159,782
Prepaid professional fees		74,500		—
Prepaid insurance		332,508		174,406
Prepaid other		146,014		105,179
Deferred offering costs		125,800		—
Total prepaid expenses and other current assets	$	1,560,354	$	708,053

INTANGIBLE ASSETS (Tables)

9 Months Ended

Sep. 30, 2023

Goodwill and Intangible Assets Disclosure [Abstract]

SCHEDULE OF FINITE LIVED INTANGIBLE ASSETS

As of September 30, 2023, the Company’s intangible assets consisted of:

Definite lived intangible assets
Balance at December 31, 2022	$	379,686
Amortization		(126,566	)
Balance at September 30, 2023	$	253,120

PROPERTY AND EQUIPMENT (Tables)

9 Months Ended

Sep. 30, 2023

Property, Plant and Equipment [Abstract]

SCHEDULE OF PROPERTY PLANT AND EQUIPMENT NET OF ACCUMULATED DEPRECIATION

	September 30, 2023			December 31, 2022
Lab equipment	$	818,460		$	831,123
Computer equipment and leasehold improvements		27,759			25,137
Less: Accumulated depreciation		(307,067	)		(178,775	)
Property and equipment, net of accumulated depreciation	$	539,152		$	677,485

ACCRUED LIABILITIES (Tables)

9 Months Ended

Sep. 30, 2023

Payables and Accruals [Abstract]

SCHEDULE OF ACCRUED LIABILITIES

As of September 30, 2023 and December 31, 2022, the accrued liabilities of the Company consisted of the following:

SCHEDULE OF ACCRUED LIABILITIES

	September 30, 2023		December 31, 2022
Product development	$	94,663	$	195,104
Accrued salaries and wages		729,616		1,175,963
Professional fees		74,499		83,255
Accrued restructuring costs		607,602		—
Accrued franchise taxes		9,449		—
Patent costs		18,000		251,333
Total accrued expenses	$	1,533,829	$	1,705,655

SHARE CAPITAL AND OTHER EQUITY INSTRUMENTS (Tables)

9 Months Ended

Sep. 30, 2023

Equity [Abstract]

SCHEDULE OF STOCK OPTION

A summary of activity under the Company’s incentive plan for the nine months ended September 30, 2023, is presented below:

SCHEDULE OF STOCK OPTION

	Number of Shares			Weighted Average Exercise Price		Weighted Average Grant Date Fair Value		Weighted Average Remaining Contractual Term (years)		Aggregate Intrinsic Value
Outstanding at December 31, 2022		48,329		$	37.05	$	44.82		4.1	$	—
Forfeited		(16,476	)	$	5.79	$	5.80		—	$	—
Outstanding at September 30, 2023		31,852		$	53.18	$	74.04		3.4	$	—
Exercisable at September 30, 2023		24,626		$	63.72	$	86.52		3.0	$	—

SCHEDULE OF RESTRICTED STOCK UNITS AND AWARDS ACTIVITY

The Company’s activity in restricted stock units was as follows for the nine months ended September 30, 2023:

	Number of shares			Weighted average fair value
Non-vested at December 31, 2022		64,053		$	92.57
Granted		182,500		$	2.73
Vested		(62,636	)	$	19.80
Forfeited		(35,666	)	$	27.45
Non-vested at September 30, 2023		148,251		$	28.39

SCHEDULE OF STOCK-BASED COMPENSATION FOR RESTRICTED STOCK UNITS

The following table summarizes the Company’s recognition of stock-based compensation for restricted stock units for the following periods:

	2023		2022		2023		2022
	Three months ended September 30,				Nine months ended September 30,
	2023		2022		2023		2022
Stock-based compensation expense for RSUs:
General and administrative	$	101,607	$	357,756	$	946,851	$	1,138,080
Research and development		226,646		232,434		691,514		794,473
Total	$	328,253	$	590,190	$	1,638,365	$	1,932,553

SCHEDULE OF WARRANTS OUTSTANDING

The following table summarizes information about shares issuable under warrants outstanding on September 30, 2023:

SCHEDULE OF WARRANTS OUTSTANDING

	Warrant shares outstanding			Weighted average exercise price		Weighted average remaining life		Intrinsic value
Outstanding at December 31, 2022		655,463		$	58.36		3.6	$	5,514
Expired		(45,570	)	$	111.50		—	$	—
Outstanding at September 30, 2023		609,893		$	50.46		2.9	$	—
Exercisable at September 30, 2023		609,893		$	50.46		2.9	$	—

SCHEDULE OF WARRANTS AND INVESTMENT OPTIONS

The following table summarizes information about investment options outstanding on September 30, 2023:

	Investment options outstanding		Weighted average exercise price		Weighted average remaining life		Intrinsic value
Outstanding at December 31, 2022		1,070,000	$	7.93		5.1	$	—
Outstanding at September 30, 2023		1,070,000	$	7.93		4.3	$	—
Exercisable at September 30, 2023		1,070,000	$	7.93		4.3	$	—

REDEEMABLE NON-CONTROLLING INTEREST (Tables)

9 Months Ended

Sep. 30, 2023

Redeemable Non-controlling Interest

SCHEDULE OF RECONCILIATION CHANGE IN REDEEMABLE NONCONTROLLING INTEREST

The table below presents the reconciliation of changes in redeemable non-controlling interest:

Balance at December 31, 2022	$	885,028
Preferred dividends attributable to redeemable non-controlling interest		19,041
Accretion of embedded derivative and transaction costs associated with Akos Series A Preferred		147,988
Redemption of Akos Series A Preferred Stock		(1,052,057	)
Balance at September 30, 2023	$	—

SCHEDULE OF RESTRUCTURING COSTS PAYABLE (Details)	9 Months Ended
SCHEDULE OF RESTRUCTURING COSTS PAYABLE (Details)	Sep. 30, 2023 USD ($)
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Restructuring cost payable, beginning
Restructuring costs incurred	1,004,033
Restructuring costs	(396,431)
Restructuring cost payable, ending	$ 607,602

BUSINESS AND LIQUIDITY AND OTHER UNCERTAINTIES (Details Narrative) - USD ($)			1 Months Ended	3 Months Ended		9 Months Ended
	Jun. 16, 2023	May 12, 2023	May 31, 2023	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022	Dec. 31, 2022
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Preferred stock, par value				$ 0.01		$ 0.01		$ 0.01
Dividends		$ 1,052,057
Accumulated deficit				$ 93,063,582		$ 93,063,582		$ 79,207,786
Net cash used in operating activities						12,343,363	$ 13,684,606
Loss from operations				3,448,395	$ 5,656,849	14,064,080	$ 15,159,453
Cash				4,266,568		4,266,568		$ 17,723,884
Working capital				$ 1,643,374		1,643,374
Severance costs			$ 453,059
Restricted Stock Units (RSUs) [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Market performance based shares	11,278
Equity Distribution Agreement [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Additional working capital						$ 2,400,000
Kanubaddi Separation Agreement [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Salaries and benefit	$ 550,974
Mr Kanubaddi Employment Agreement [Member] \| Restricted Stock Units (RSUs) [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Expense related to acceleration of vesting	$ 231,273
Market performance based shares	3,759
Series A Preferred Stock [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Preferred stock, par value		$ 0.01
Dividends, per share		$ 1,000	$ 1,000
Unpaid dividends		$ 52,057	$ 52,000
Dividends			$ 1,052,000

SCHEDULE OF POTENTIALLY DILUTIVE SECURITIES (Details) - shares	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Total potentially dilutive securities	1,880,843	1,875,811	1,880,843	1,875,811
Warrants to Purchase Shares of Common Stock [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Total potentially dilutive securities	609,893	655,463	609,893	655,463
Restricted Stock Units Vested and Unissued [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Total potentially dilutive securities	20,847	61,428	20,847	61,428
Restricted Stock Units Unvested [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Total potentially dilutive securities	148,251	65,117	148,251	65,117
Restricted Stock Awards Vested and Unissued [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Total potentially dilutive securities		974		974
Investment Options to Purchase Shares of Common Stock [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Total potentially dilutive securities	1,070,000	1,070,000	1,070,000	1,070,000
Options to Purchase Shares of Common Stock [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Total potentially dilutive securities	31,852	22,829	31,852	22,829

SCHEDULE OF FAIR VALUE HIERARCHY OF VALUATION INPUTS ON RECURRING BASIS (Details) - Fair Value, Inputs, Level 3 [Member] - Fair Value, Recurring [Member] - USD ($)	Sep. 30, 2023	Dec. 31, 2022
Class of Warrant or Right [Line Items]
Fair value of warrant liability	$ 300,557	$ 185,215
Fair value of derivative liability		727,000
Fair value of investment option liability	1,250,929	851,008
Derivative liability - May 2022 [Member]
Class of Warrant or Right [Line Items]
Fair value of derivative liability		727,000
HC Wainwright and Co LLC Investment Options [Member]
Class of Warrant or Right [Line Items]
Fair value of investment option liability	70,521	44,904
RD Investment Options [Member]
Class of Warrant or Right [Line Items]
Fair value of investment option liability	442,653	302,289
PIPE Investment Options [Member]
Class of Warrant or Right [Line Items]
Fair value of investment option liability	737,755	503,815
Warrant liabilities - January 2021 Warrants [Member]
Class of Warrant or Right [Line Items]
Fair value of warrant liability	18	81
Warrant liabilities - February 2021 Warrants [Member]
Class of Warrant or Right [Line Items]
Fair value of warrant liability	59	79
Warrant liabilities - February 2022 Warrants [Member]
Class of Warrant or Right [Line Items]
Fair value of warrant liability	$ 300,480	$ 185,055

SCHEDULE OF FAIR VALUE OF WARRANT LIABILITIES AND DERIVATIVE LIABILITY AND INVESTMENT OPTIONS (Details) - Fair Value, Inputs, Level 3 [Member]	9 Months Ended
	Sep. 30, 2023 USD ($)
Warrant [Member]
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items]
Total beginning balance	$ 185,215
Change in fair value	115,342
Total ending balance	300,557
Derivative [Member]
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items]
Total beginning balance	727,000
Change in fair value	(727,000)
Total ending balance
Options Held [Member]
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items]
Total beginning balance	851,008
Change in fair value	399,921
Total ending balance	$ 1,250,929

SCHEDULE OF BLACK SCHOLES VALUATION MODELS OF WARRANT LIABILITIES AND INVESTMENT OPTIONS (Details) - Subsequent Measurement [Member]	9 Months Ended
	Sep. 30, 2023 USD ($) $ / shares shares
May Twenty Twenty Two Derivative Liability [Member]
Principal \| $
HC Wainwright and Co LLC Investment Options [Member]
Value (per share)	$ 1.01
Investment option term	3 years 9 months 18 days
Number of investment options \| shares	70,000
RD Offering Investment Options [Member]
Value (per share)	$ 1.18
Investment option term	4 years 3 months 18 days
Number of investment options \| shares	375,000
PIPE Offering Investment Options [Member]
Value (per share)	$ 1.18
Investment option term	4 years 3 months 18 days
Number of investment options \| shares	625,000
Measurement Input, Share Price [Member] \| HC Wainwright and Co LLC Investment Options [Member]
Investment, stock price	$ 2.38
Investment, exercise price	10.00
Measurement Input, Share Price [Member] \| RD Offering Investment Options [Member]
Investment, stock price	2.38
Investment, exercise price	7.78
Measurement Input, Share Price [Member] \| PIPE Offering Investment Options [Member]
Investment, stock price	2.38
Investment, exercise price	$ 7.78
Measurement Input, Expected Dividend Rate [Member] \| May Twenty Twenty Two Derivative Liability [Member]
Investment, measurement input
Measurement Input, Expected Dividend Rate [Member] \| HC Wainwright and Co LLC Investment Options [Member]
Investment, measurement input
Measurement Input, Expected Dividend Rate [Member] \| RD Offering Investment Options [Member]
Investment, measurement input
Measurement Input, Expected Dividend Rate [Member] \| PIPE Offering Investment Options [Member]
Investment, measurement input
Measurement Input, Option Volatility [Member] \| HC Wainwright and Co LLC Investment Options [Member]
Investment, measurement input	97.0
Measurement Input, Option Volatility [Member] \| RD Offering Investment Options [Member]
Investment, measurement input	94.0
Measurement Input, Option Volatility [Member] \| PIPE Offering Investment Options [Member]
Investment, measurement input	94.0
Measurement Input, Risk Free Interest Rate [Member] \| HC Wainwright and Co LLC Investment Options [Member]
Investment, measurement input	4.70
Measurement Input, Risk Free Interest Rate [Member] \| RD Offering Investment Options [Member]
Investment, measurement input	4.70
Measurement Input, Risk Free Interest Rate [Member] \| PIPE Offering Investment Options [Member]
Investment, measurement input	4.70
Measurement Input Expected Market Rate [Member] \| HC Wainwright and Co LLC Investment Options [Member]
Investment, measurement input
January 2021 Warrants [Member]
Warrants term	2 years 3 months 18 days
Warrants, number of warrants \| shares	36,429
Value (per share)
January 2021 Warrants [Member] \| Measurement Input, Share Price [Member]
Warrant measurement input	2.38
January 2021 Warrants [Member] \| Measurement Input, Exercise Price [Member]
Warrant measurement input	$ 247.50
January 2021 Warrants [Member] \| Measurement Input, Expected Dividend Rate [Member]
Warrants, measurement input
January 2021 Warrants [Member] \| Measurement Input, Option Volatility [Member]
Warrants, measurement input	80.0
January 2021 Warrants [Member] \| Measurement Input, Risk Free Interest Rate [Member]
Warrants, measurement input	5.00
February 2021 Warrants [Member]
Warrants term	2 years 4 months 24 days
Warrants, number of warrants \| shares	34,281
Value (per share)
February 2021 Warrants [Member] \| Measurement Input, Share Price [Member]
Warrant measurement input	2.38
February 2021 Warrants [Member] \| Measurement Input, Exercise Price [Member]
Warrant measurement input	$ 245.00
February 2021 Warrants [Member] \| Measurement Input, Expected Dividend Rate [Member]
Warrants, measurement input
February 2021 Warrants [Member] \| Measurement Input, Option Volatility [Member]
Warrants, measurement input	85.0
February 2021 Warrants [Member] \| Measurement Input, Risk Free Interest Rate [Member]
Warrants, measurement input	4.90
February 2022 Warrants [Member]
Warrants term	3 years 4 months 24 days
Warrants, number of warrants \| shares	338,000
Value (per share)	$ 0.46
February 2022 Warrants [Member] \| Measurement Input, Share Price [Member]
Warrant measurement input	2.38
February 2022 Warrants [Member] \| Measurement Input, Exercise Price [Member]
Warrant measurement input	$ 27.50
February 2022 Warrants [Member] \| Measurement Input, Expected Dividend Rate [Member]
Warrants, measurement input
February 2022 Warrants [Member] \| Measurement Input, Option Volatility [Member]
Warrants, measurement input	96.0
February 2022 Warrants [Member] \| Measurement Input, Risk Free Interest Rate [Member]
Warrants, measurement input	4.80
February 2022 Post Modification Warrants [Member]
Warrants term	4 years 3 months 18 days
Warrants, number of warrants \| shares	122,000
Value (per share)	$ 1.18
February 2022 Post Modification Warrants [Member] \| Measurement Input, Share Price [Member]
Warrant measurement input	2.38
February 2022 Post Modification Warrants [Member] \| Measurement Input, Exercise Price [Member]
Warrant measurement input	$ 7.78
February 2022 Post Modification Warrants [Member] \| Measurement Input, Expected Dividend Rate [Member]
Warrants, measurement input
February 2022 Post Modification Warrants [Member] \| Measurement Input, Option Volatility [Member]
Warrants, measurement input	94.0
February 2022 Post Modification Warrants [Member] \| Measurement Input, Risk Free Interest Rate [Member]
Warrants, measurement input	4.70

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Narrative) - USD ($)	Sep. 30, 2023	Dec. 31, 2022
Deferred offering costs	$ 125,800
UNITED STATES
Cash FDIC insured amount	250,000
CANADA
Cash FDIC insured amount	100,000
AUSTRALIA
Cash FDIC insured amount	$ 250,000

SCHEDULE OF PREPAID EXPENSES AND OTHER CURRENT ASSETS (Details) - USD ($)	Sep. 30, 2023	Dec. 31, 2022
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract]
Prepaid research and development	$ 651,623	$ 268,686
Prepaid value-added taxes	229,909	159,782
Prepaid professional fees	74,500
Prepaid insurance	332,508	174,406
Prepaid other	146,014	105,179
Deferred offering costs	125,800
Total prepaid expenses and other current assets	$ 1,560,354	$ 708,053

SCHEDULE OF FINITE LIVED INTANGIBLE ASSETS (Details) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Goodwill and Intangible Assets Disclosure [Abstract]
Balance, Definite lived intangible assets			$ 379,686
Amortization	$ (42,191)	$ (42,191)	(126,566)	$ (126,563)
Balance, Definite lived intangible assets	$ 253,120		$ 253,120

INTANGIBLE ASSETS (Details Narrative) - USD ($)	3 Months Ended		9 Months Ended
INTANGIBLE ASSETS (Details Narrative) - USD ($)	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Goodwill and Intangible Assets Disclosure [Abstract]
Identified definite lived assets, impairment loss	$ 0	$ 0	$ 0	$ 0
Intangible assets, amortization expense	$ 42,191	$ 42,191	$ 126,566	$ 126,563

SCHEDULE OF PROPERTY PLANT AND EQUIPMENT NET OF ACCUMULATED DEPRECIATION (Details) - USD ($)	Sep. 30, 2023	Dec. 31, 2022
Property, Plant and Equipment [Line Items]
Less: Accumulated depreciation	$ (307,067)	$ (178,775)
Property and equipment, net of accumulated depreciation	539,152	677,485
Lab Equipment [Member]
Property, Plant and Equipment [Line Items]
Computer equipment and leasehold improvements	818,460	831,123
Computer Equipment and Leasehold Improvements [Member]
Property, Plant and Equipment [Line Items]
Computer equipment and leasehold improvements	$ 27,759	$ 25,137

PROPERTY AND EQUIPMENT (Details Narrative) - USD ($)	3 Months Ended		9 Months Ended
PROPERTY AND EQUIPMENT (Details Narrative) - USD ($)	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Property, Plant and Equipment [Abstract]
Depreciation expense	$ 44,105	$ 44,458	$ 132,734	$ 114,850

SCHEDULE OF ACCRUED LIABILITIES (Details) - USD ($)	Sep. 30, 2023	Dec. 31, 2022
Payables and Accruals [Abstract]
Product development	$ 94,663	$ 195,104
Accrued salaries and wages	729,616	1,175,963
Professional fees	74,499	83,255
Accrued restructuring costs	607,602
Accrued franchise taxes	9,449
Patent costs	18,000	251,333
Total accrued expenses	$ 1,533,829	$ 1,705,655

SCHEDULE OF STOCK OPTION (Details)	9 Months Ended
SCHEDULE OF STOCK OPTION (Details)	Sep. 30, 2023 USD ($) $ / shares shares
Equity [Abstract]
Number of Shares, Outstanding at beginning \| shares	48,329
Weighted Average Exercise Price, Outstanding at beginning	$ 37.05
Weighted Average Grant Date Fair Value, Outstanding at beginning	$ 44.82
Weighted Average Remaining Contractual Term (years)	4 years 1 month 6 days
Aggregate Intrinsic Value, Outstanding at beginning \| $
Number of Shares, Forfeited \| shares	(16,476)
Weighted Average Exercise Price, Forfeited	$ 5.79
Weighted Average Grant Date Fair Value, Forfeited	$ 5.80
Number of Shares, Outstanding at end \| shares	31,852
Weighted Average Exercise Price, Outstanding at end	$ 53.18
Weighted Average Grant Date Fair Value, Outstanding at end	$ 74.04
Weighted Average Remaining Contractual Term (years), Outstanding	3 years 4 months 24 days
Aggregate Intrinsic Value, Outstanding at end \| $
Number of Shares, Exercisable \| shares	24,626
Weighted Average Exercise Price, Exercisable	$ 63.72
Weighted Average Grant Date Fair Value, Exercisable	$ 86.52
Weighted Average Remaining Contractual Term (years), Exercisable	3 years
Aggregate Intrinsic Value, Exercisable \| $

SCHEDULE OF RESTRICTED STOCK UNITS AND AWARDS ACTIVITY (Details) - Restricted Stock Units (RSUs) [Member]	9 Months Ended
	Sep. 30, 2023 $ / shares shares
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Number of shares, non-vested beginning \| shares	64,053
Weighted average fair value, non-vested beginning \| $ / shares	$ 92.57
Number of shares, granted \| shares	182,500
Weighted average fair value, granted \| $ / shares	$ 2.73
Number of shares, vested \| shares	(62,636)
Weighted average fair value, vested \| $ / shares	$ 19.80
Number of shares, forfeited \| shares	(35,666)
Weighted average fair value, forfeited \| $ / shares	$ 27.45
Number of shares, non-vested ending \| shares	148,251
Weighted average fair value, non-vested ending \| $ / shares	$ 28.39

SCHEDULE OF STOCK-BASED COMPENSATION FOR RESTRICTED STOCK UNITS (Details) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Total	$ 328,253	$ 590,190	$ 1,638,365	$ 1,932,553
General and Administrative Expense [Member]
Total	101,607	357,756	946,851	1,138,080
Research and Development Expense [Member]
Total	$ 226,646	$ 232,434	$ 691,514	$ 794,473

SCHEDULE OF WARRANTS OUTSTANDING (Details) - Warrant [Member] - USD ($)	9 Months Ended	12 Months Ended
	Sep. 30, 2023	Dec. 31, 2022
Accumulated Other Comprehensive Income (Loss) [Line Items]
Warrant shares outstanding,exchanged for common stock	655,463
Weighted average exercise price, issued	$ 58.36
Weighted average remaining life, outstanding ended	2 years 10 months 24 days	3 years 7 months 6 days
Intrinsic value,beginning	$ 5,514
Warrant shares outstanding, Expired	(45,570)
Weighted average exercise price, Expired	$ 111.50
Warrant shares outstanding,exchanged for common stock	609,893
Weighted average exercise price, issued	$ 50.46
Intrinsic value, ending		$ 5,514
Warrant shares outstanding,exchanged for common stock	609,893
Weighted average exercise price, exercisable	$ 50.46
Weighted average remaining life, exercisable	2 years 10 months 24 days
Exercisable intrinsic value

SCHEDULE OF WARRANTS AND INVESTMENT OPTIONS (Details) - Investment Options [Member] - $ / shares	9 Months Ended	12 Months Ended
	Sep. 30, 2023	Dec. 31, 2022
Accumulated Other Comprehensive Income (Loss) [Line Items]
Investment options outstanding, issued	1,070,000
Weighted average exercise price, issued	$ 7.93
Weighted average remaining life, outstanding ended	4 years 3 months 18 days	5 years 1 month 6 days
Warrant shares outstanding,exchanged for common stock	1,070,000
Weighted average exercise price, issued	$ 7.93
Warrant shares outstanding,exchanged for common stock	1,070,000
Weighted average exercise price, exercisable	$ 7.93
Weighted average remaining life, exercisable	4 years 3 months 18 days

SHARE CAPITAL AND OTHER EQUITY INSTRUMENTS (Details Narrative) - USD ($)						3 Months Ended			9 Months Ended
	Sep. 01, 2023	Jul. 26, 2022	Jul. 22, 2022	May 03, 2022	Feb. 15, 2022	Sep. 30, 2023	Jun. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022	Dec. 31, 2022
Subsidiary, Sale of Stock [Line Items]
Common stock voting rights									The holders of the Company’s common stock are entitled to one vote per share
Common stock, shares authorized						100,000,000			100,000,000		100,000,000
Preferred stock, shares authorized						20,000,000			20,000,000		20,000,000
Common stock, par value						$ 0.01			$ 0.01		$ 0.01
Offering expenses						$ 125,800			$ 125,800
Offerings costs									105,000
Incentive plan description				(i) increase the aggregate number of shares available for the grant of awards by 146,083 shares to a total of 200,000 shares, and (ii) add an “evergreen” provision whereby the number of shares authorized for issuance pursuant to awards under the Incentive Plan will be automatically increased on the first trading date immediately following the date the Company issues any share of Common Stock (defined below) to any person or entity, to the extent necessary so that the number of shares of the Company’s Common Stock authorized for issuance under the Incentive Plan will equal the greater of (x) 200,000 shares, and (y) 15% of the total number of shares of the Company’s Common Stock outstanding as of such issuance date. The Plan Amendment was approved by the Company’s shareholders at a special meeting of the Company’s shareholders held on July 14, 2022
Stock based compensation, expenses						328,253		$ 590,190	1,638,365	1,932,553
Share-Based Payment Arrangement, Option [Member]
Subsidiary, Sale of Stock [Line Items]
Stock based compensation, expenses						44,606		48,697	147,067	134,383
Stock-based compensation, unamortized						93,697			$ 93,697
Weighted average period									1 year
Restricted Stock [Member]
Subsidiary, Sale of Stock [Line Items]
Stock based compensation, expenses						$ 0		6,250	$ 0	24,363
Common stock vested restricted stock units						708
Unissued shares for cash						$ 14,250
Number of vested and unissued shares						0			0
Restricted Stock Units (RSUs) [Member]
Subsidiary, Sale of Stock [Line Items]
Stock based compensation, expenses						$ 328,253		$ 590,190	$ 1,638,365	$ 1,932,553
Stock-based compensation, unamortized						$ 2,388,221			$ 2,388,221
Weighted average period									2 years 3 months 18 days
Common stock vested restricted stock units									62,636
Common Stock [Member]
Subsidiary, Sale of Stock [Line Items]
Issuance of common shares in exchange for RSU conversions from the reduction in force, shares						40,130	63,511		103,641	2,122
Common Stock [Member] \| Restricted Stock Units (RSUs) [Member]
Subsidiary, Sale of Stock [Line Items]
Common stock vested restricted stock units									20,847
RD Offering and Pipe Investment Options [Member]
Subsidiary, Sale of Stock [Line Items]
Proceeds from RD offerings		$ 8,000,000
Offerings costs		7,100,000
Payments of allocated equity		3,200,000
Payments of investment option liability		4,300,000
Payments of stock issuance costs recorded expense		$ 400,000
Underwriters [Member]
Subsidiary, Sale of Stock [Line Items]
Offering expenses					$ 5,800,000
Issued shares					60,000
Purchase of common stock					60,000
Exercised of warrants					60,000
Net proceeds from offering					$ 9,100,000
Warrant liability					3,600,000
Proceeds from issuance of warrants					$ 300,000
IPO [Member]
Subsidiary, Sale of Stock [Line Items]
Issued shares					400,000
Purchase of common stock					400,000
Proceeds from common stock					$ 10,000,000.0
Distribution Agreement [Member] \| Canaccord Genuity LLC [Member]
Subsidiary, Sale of Stock [Line Items]
Common stock, par value	$ 0.01
Common stock, offering price	$ 10,000,000.0
Aggregate gross sales price	$ 2,392,514
Commission percentage	3.00%
Offering expenses						$ 125,800			$ 125,800
Registered Direct Securities Purchase Agreement [Member]
Subsidiary, Sale of Stock [Line Items]
Issued shares			375,000
Purchase of common stock			258,500
Proceeds from issuance of warrants			$ 3,000,000
Sale of stock			116,500
Share price			$ 0.0001
PIPE Securities Purchase Agreement [Member]
Subsidiary, Sale of Stock [Line Items]
Issued shares			625,000
Purchase of common stock			509,000
Proceeds from issuance of warrants			$ 5,000,000
Sale of stock			116,000
Share price			$ 0.0001

SCHEDULE OF RECONCILIATION CHANGE IN REDEEMABLE NONCONTROLLING INTEREST (Details) - USD ($)	9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022
Redeemable Non-controlling Interest
Beginning balance	$ 885,028
Issuance of redeemable noncontrolling Series C preferred stock	19,041
Accretion of embedded derivative to redemption value	147,988
Redemption of Akos Series A Preferred Stock	(1,052,057)
Ending balance

REDEEMABLE NON-CONTROLLING INTEREST (Details Narrative) - USD ($)			1 Months Ended	9 Months Ended
	May 12, 2023	May 05, 2022	May 31, 2023	Sep. 30, 2023	Jun. 30, 2023	Dec. 31, 2022
Common stock par value				$ 0.01		$ 0.01
Dividends	$ 1,052,057
Derivative liabilities					$ 714,000
Redeemable non-controlling interest						$ 885,028
Series A Preferred Stock [Member]
Dividends, per share	$ 1,000		$ 1,000
Unpaid dividends	$ 52,057		$ 52,000
Dividends			1,052,000
Redeemable noncontrolling interest			$ 1,052,057
Akos Securities Purchase Agreement [Member]
Common stock par value		$ 0.01
Sale of stock, value		$ 4,000,000
Spin-off and related private placement, description		Pursuant to the Akos Purchase Agreement, Akos had agreed to pay Palladium a fee equal to 9% of the aggregate gross proceeds raised from the sale of the shares of the Akos Series A Preferred Stock and a non-accountable expense allowance of 1% of the aggregate gross proceeds raised the sale of the Akos Series A Preferred Stock in the Akos Private Placement. The fee due in connection with the Akos Private Placement to be paid to Palladium in the form of convertible preferred stock and warrants was on similar terms to the securities issued in the Akos Private Placement.
Warrants to purchase common stock, percentage				8.00%
Akos Securities Purchase Agreement [Member] \| Maximum [Member]
Sale of stock, value		$ 5,000,000
Akos Securities Purchase Agreement [Member] \| Series A Convertible Preferred Stock [Member]
Sale of stock		5,000
Sale of stock, price per share		$ 1,000
Akos Securities Purchase Agreement [Member] \| Series A Preferred Stock [Member]
Sale of stock		1,000
Sale of stock, value		$ 1,000,000
Securities purchase agreement [Member]
Sale of stock, price per share		$ 1,000
Securities purchase agreement [Member] \| Series A Preferred Stock [Member] \| Akos [Member]
Percentage of stock issued and outstanding		25.00%
Dividend rate		5.00%

COMMITMENTS AND CONTINGENCIES (Details Narrative)		3 Months Ended		9 Months Ended
COMMITMENTS AND CONTINGENCIES (Details Narrative)	Dec. 26, 2017 USD ($)	Sep. 30, 2023 USD ($)	Sep. 30, 2022 USD ($)	Sep. 30, 2023 USD ($)	Sep. 30, 2022 USD ($)	Mar. 23, 2023 USD ($)	Mar. 23, 2023 AUD ($)	Dec. 31, 2022 USD ($)
Property, Plant and Equipment [Line Items]
Prepaid assets		$ 1,560,354		$ 1,560,354				$ 708,053
research and development expenses		1,351,750	$ 2,055,656	5,883,440	$ 6,134,421
Future cash		4,266,568		4,266,568				$ 17,723,884
Vogal Nathan Purchase Agreement [Member] \| One Time Milestone [Member]
Property, Plant and Equipment [Line Items]
Long-term purchase commitment, amount	$ 200,000
Vogal Nathan Purchase Agreement [Member] \| Additional Milestone [Member]
Property, Plant and Equipment [Line Items]
Long-term purchase commitment, amount	$ 300,000
Other Consulting and Vendor Agreements [Member]
Property, Plant and Equipment [Line Items]
Future cash		1,200,000		1,200,000
Avance Clinical [Member]
Property, Plant and Equipment [Line Items]
Contract cost		950,997		950,997		$ 2,000,000	$ 3,000,000
Prepaid assets		549,713		549,713
research and development expenses		$ 157,117		$ 401,284

SUBSEQUENT EVENTS (Details Narrative) - USD ($) $ / shares in Units, $ in Millions	Nov. 03, 2023	Nov. 02, 2023	Sep. 30, 2023	Dec. 31, 2022
Subsequent Event [Line Items]
Common stock, par value			$ 0.01	$ 0.01
Subsequent Event [Member] \| 2020 Long Term Incentive Plan [Member]
Subsequent Event [Line Items]
Authorized shares reserved		350,000
Registration Rights Agreement [Member] \| Subsequent Event [Member]
Subsequent Event [Line Items]
Common stock, par value	$ 0.01
Purchase committment	$ 10.0
Registration Rights Agreement [Member] \| Subsequent Event [Member] \| Lincoln Park Capital Fund, LLC [Member]
Subsequent Event [Line Items]
Purchase committment	$ 10.0

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