Enveric Biosciences, Inc 10-K for FY2023

Enveric Biosciences, Inc. (ENVB)

10-K 2024-03-26 For: 2023-12-31

Added on April 10, 2026

About this 10-K

Enveric Biosciences, Inc filed this 10-K on March 26, 2024, covering the fiscal year ended December 31, 2023 (FY2023).

Headline figures

Fiscal year ended December 31, 2023, as reported in this filing, compared with the same period a year earlier where the filing states it.

Net loss: $17.29M; compared with a net loss of $18.47M a year earlier
Diluted EPS: -$8.09; compared with -$13.00 a year earlier

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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

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

		Page
	PART I - FINANCIAL INFORMATION
Item 1.	Business	4
Item 1A.	Risk Factors	19
Item 1B.	Unresolved Staff Comments	48
Item 1C.	Cybersecurity	49
Item 2.	Properties	49
Item 3.	Legal Proceedings	49
Item 4.	Mine Safety Disclosures	49
	PART II - OTHER INFORMATION
Item 5.	Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities	50
Item 6.	[Reserved]	50
Item 7.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	51
Item 7A.	Quantitative and Qualitative Disclosure About Market Risk	61
Item 8.	Financial Statements and Supplementary Data	61
Item 9.	Changes in and Disagreements with Accountants on Accounting and Financial Disclosure	61
Item 9A.	Controls and Procedures	61
Item 9B.	Other Information	63
Item 9C.	Disclosure Regarding Foreign Jurisdictions that Prevent Inspections	63
	PART III
Item 10.	Directors, Executive Officers and Corporate Governance	64
Item 11.	Executive Compensation	64
Item 12.	Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters	64
Item 13.	Certain Relationships and Related Transactions and Director Independence	64
Item 14.	Principal Accountant Fees and Services	64
	PART IV
Item 15.	Exhibits and Financial Statement Schedules	65
Item 16.	Form 10–K Summary	65
SIGNATURES		69

	●	our dependence on the success of our prospective product candidates, which are in early stages of development and may not reach a particular stage in development, receive regulatory approval or be successfully commercialized;

	●	potential difficulties that may delay, suspend, or scale back our efforts to advance additional early research programs through preclinical development and investigational new drug (“IND”) application filings and into clinical development;

	●	the risk that the cost savings, synergies and growth from our combination with MagicMed Industries Inc. and the successful use of the rights and technologies acquired in the combination may not be fully realized or may take longer to realize than expected;

	●	the limited study on the effects of psychedelics, and the chance that future clinical research studies may lead to conclusions that dispute or conflict with our understanding and belief regarding the medical benefits, viability, safety, efficacy, dosing, and social acceptance of psychedelics;

	●	the expensive, time-consuming, and uncertain nature of clinical trials, which are susceptible to change, delays, termination, and differing interpretations;

	●	the ability to establish that potential products are efficacious or safe in preclinical or clinical trials;

	●	the fact that our current and future preclinical and clinical studies may be conducted outside the United States, and the United States Food and Drug Administration may not accept data from such studies to support any new drug applications we may submit after completing the applicable developmental and regulatory prerequisites;

	●	our ability to effectively and efficiently build, maintain and legally protect our molecular derivatives library so that it can be an essential building block from which those in the biotech industry can develop new patented products;

	●	our ability to establish or maintain collaborations on the development of therapeutic candidates;

	●	our ability to obtain appropriate or necessary governmental approvals to market potential products;

	●	our ability to manufacture product candidates on a commercial scale or in collaborations with third parties;

	●	our significant and increasing liquidity needs and potential requirements for additional funding;

	●	our ability to obtain future funding for developing products and working capital and to obtain such funding on commercially reasonable terms;

	●	legislative changes related to and affecting the healthcare system, including, without limitation, changes and proposed changes to the Patient Protection and Affordable Care Act (“PPACA”);

	●	the intense competition we face, often from companies with greater resources and experience than us;

	●	our ability to retain key executives and scientists;

	●	the ability to secure and enforce legal rights related to our products, including intellectual property rights and patent protection;

	●	political, economic, and military instability in Israel which may impede our development programs; and

	●	other factors described in the “Risk Factors” section of this Annual Report on Form 10-K

Product Candidates	Targeted Indications	Status	Expected Next Steps
EB-002
Second-generation psychedelic asset: prodrug of psilocin	Anxiety	Pre-Clinical Development	Filing of HREC for FIH study in Australia
EB-003
Third-generation psychedelic-inspired new chemical entity	Mental health indication	Pre-Clinical Development	IND Filing

	●	Glycosylated Psilocybin Derivatives and Methods of Using (WO 2022/040802)

	●	Halogenated Psilocybin Derivatives and Methods of Using (WO2022047579)

	●	Hydroxylated Psilocybin Derivatives and Methods of Using (WO2022047580)

	●	Nitrated Psilocybin Derivatives and Methods of Using (WO 2022/047583)

	●	Aminated Psilocybin Derivatives and Methods of Using (WO2023044556A1)

	●	Nitrilated Psilocybin Derivatives and Methods of Using (WO2022104475A1)

	●	Carboxylated Psilocybin Derivatives and Methods of Using (WO2022115944)

	●	Aldehyde and Ketone Derivatives of Psilocybin and Methods of Using (WO2022115960)

	●	Prenylated Psilocybin Derivatives and Methods of Using (WO2022155751)

	●	Multi-substituent Psilocybin Derivatives and Methods of Using (WO2022170438)

	●	C-4 Substituted Tryptamine Derivatives and Methods of Using (WO2023/173227A1) - This application relates to several groups of novel C4-substituted tryptamine derivative compounds and pharmaceutical drug formulations containing C4-ether-substituted tryptamine derivative compounds, C4-carbonic ester- substituted tryptamine derivative compounds, C4-polyether substituted tryptamine derivative compounds, and C4-phosphate substituted tryptamine derivative compounds. These pharmaceutical formulations may be used to treat psychiatric disorders.

	●	C-4 Carboxylic Acid Substituted Tryptamine Derivatives and Methods of Using (WO2023/173196A1)

	●	C-4 Carbanothioate Substituted Tryptamine Derivatives and Methods of Using (WO 2023/173197)

	●	Salts of C4-Carboxylic Acid and C4-Carbonothioate-substituted Tryptamine Derivatives and Methods of Using (WO 2023/173229)

	●	Fused Heterocyclic Mescaline Derivatives (WO2024026568A1)

	●	Three unpublished applications directed to three other groups of novel Mescaline Derivatives, described in PCT/CA2023/051422, PCT/CA2023/051548, and PCT/CA2023/051670

	●	Four unpublished United States Track One Patent Applications, one each corresponding to each of the four PCT application in this family

	●	Glycosylated Mescaline Derivatives and Methods of Using (WO2023/102658)

	●	Isopropylamine Analogues of Glycosylated Mescaline Derivatives (WO2023/102659)

	●	Phosphorylated and Sulfonated Mescaline Derivatives and Methods of Using (WO 2023/044574)

	●	Isopropylamine Analogues of Phosphorylated and Sulfonated Mescaline Derivatives (WO 2023/108296)

	●	Cannabinoid Conjugate Molecules (WO2020263888A1) (In-licensed)

	●	Conjugate Molecules (WO2021076197A1) (In-licensed)

	●	Cannabinoid Conjugate Molecules (WO2023150057A1) (wholly owned by Enveric’s subsidiary Akos Biosciences, Inc.)

	●	Combination of a cannabinoid and a chemotherapeutic agent for the treatment of breast cancer (WO2019193112A1)

	●	Administration regimes of cannabinoids in combination with chemotherapeutics against cancer (WO2021028646A1

Name	Title	Specialization
Maurizio Fava, M.D.	Executive Director of the Clinical Trials Network and Institute	Clinical Research

Stephen M. Stahl, M.D., Ph.D.	Director of Psychopharmacology for the California Department of State Hospitals	Clinical Research

Sheila DeWitt, Ph.D.	Chair, President & CEO of DeuteRx, LLC; COO of Neuromity Therapeutics, Inc.; Founder of RIFFIT, Inc.	Therapeutics R&D

John Krystal, M.D.	Director of Yale Center for Clinical Investigation	Clinical Research

	●	Completion of preclinical laboratory tests, animal studies, and formulation studies according to Good Laboratory Practices and other applicable regulations;

	●	Submission to the FDA of an IND application, which must become effective before human clinical trials may begin in the United States;

	●	Performance of adequate and well-controlled human clinical trials according to the FDA’s current good clinical practices, or GCPs, which sufficiently demonstrate the safety and efficacy of the proposed drug or biologic for its intended uses;

	●	Submission to the FDA of a New Drug Application, or an NDA, for a new drug product;

	●	Satisfactory completion of an FDA inspection of the manufacturing facility or facilities where the drug or biologic is to be produced to assess compliance with the FDA’s current good manufacturing practice standards, or cGMP, to assure that the facilities, methods and controls are adequate to preserve the drug’s or biologic’s identity, strength, quality and purity;

	●	Potential FDA audit of the nonclinical and clinical trial sites that generated the data in support of the NDA or biologics license application; and

	●	FDA review and, potentially, approval of the NDA.

	●	delays or difficulties in enrolling patients in clinical trials, specifically since many of the patients are considered immunocompromised;

	●	delays or difficulties in clinical site initiation, including difficulties in recruiting clinical site investigators and clinical site staff;

	●	diversion of healthcare resources away from the conduct of clinical trials, including the diversion of hospitals serving as our clinical trial sites and hospital staff supporting the conduct of our clinical trials;

	●	interruption of key clinical trial activities, such as clinical trial site monitoring, due to limitations on travel imposed or recommended by federal or state governments, employers and others;

	●	limitations in employee resources that would otherwise be focused on the conduct of our clinical trials, including because of sickness of employees or their families or the desire of employees to avoid contact with large groups of people;

	●	delays in receiving approval from local regulatory authorities to initiate our planned clinical trials;

	●	delays in clinical sites receiving the supplies and materials needed to conduct our clinical trials;

	●	interruption in global shipping that may affect the transport of clinical trial materials, such as investigational drug product used in our clinical trials

	●	changes in local regulations as part of a response to a catastrophic event which may require us to change the ways in which our clinical trials are conducted, which may result in unexpected costs, or to discontinue the clinical trials altogether;

	●	delays in necessary interactions with local regulators, ethics committees and other important agencies and contractors due to limitations in employee resources or forced furlough of government employees;

	●	delay in the timing of interactions with the FDA due to absenteeism by federal employees or by the diversion of their efforts and attention to approval of other therapeutics or other activities related ; and

	●	refusal of the FDA to accept data from clinical trials in affected geographies outside the United States.

	●	the scope, number, initiation, progress, timing, costs, design, duration, delays (if any), and results of preclinical and clinical studies for our current or future product candidates;

	●	the outcome, timing and cost of regulatory reviews, approvals or other actions to meet regulatory requirements established by the FDA, and comparable foreign regulatory authorities;

	●	the timing and amount of revenue generated or received, including any revenue from grants or other sources;

	●	the rate of progress and cost of our clinical trials and other product development programs;

	●	costs of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights associated with our current and future product candidates;

	●	the effect of competing technological and market developments;

	●	personnel, facilities and equipment requirements; and

	●	the terms and timing of any additional collaborative, licensing, co-promotion or other arrangements that we may establish.

	●	preclinical study results that may show the product to be less effective than desired (e.g., the study failed to meet our primary objectives) or to have harmful or problematic side effects;

	●	failure to receive the necessary regulatory approvals or a delay in receiving such approvals. Among other things, such delays may be caused by slow enrollment in clinical studies, length of time to achieve study endpoints, additional time requirements for data analysis or an IND and later NDA, preparation, discussions with the FDA, an FDA request for additional preclinical or clinical data or unexpected safety or manufacturing issues;

	●	manufacturing costs, pricing, or reimbursement issues or other factors that make the product not economical; and

	●	the proprietary rights of others and their competing products and technologies that may prevent the product from being commercialized.

	●	the scope, number, progress, duration, endpoints, cost, results, and timing of our preclinical testing and clinical studies of current or potential future product candidates;

	●	our ability to obtain additional funding to develop product candidates; and

	●	delays in the commencement, enrollment and timing of clinical studies.

	●	DEA registration and inspection of facilities. Facilities conducting research, manufacturing, distributing, importing or exporting, or dispensing controlled substances must be registered (licensed) to perform these activities and have the security, control, recordkeeping, reporting and inventory mechanisms required by the DEA to prevent drug loss and diversion. All these facilities must renew their registrations annually, except dispensing facilities, which must renew every three years. The DEA conducts periodic inspections of certain registered establishments that handle controlled substances. Obtaining and maintaining the necessary registrations may result in delay of the importation, manufacturing or distribution of product candidates. Furthermore, failure to maintain compliance with the CSA, particularly non-compliance resulting in loss or diversion, can result in regulatory action that could have a material adverse effect on our business, financial condition and results of operations. The DEA may seek civil penalties, refuse to renew necessary registrations, or initiate proceedings to restrict, suspend or revoke those registrations. In certain circumstances, violations could lead to criminal proceedings.

	●	State controlled-substances laws. Individual U.S. states have also established controlled substance laws and regulations. Though state-controlled substances laws often mirror federal law, because the states are separate jurisdictions, they may separately schedule product candidates. While some states automatically schedule a drug based on federal action, other states schedule drugs through rule making or a legislative action. State scheduling may delay commercial sale of any product for which we obtain federal regulatory approval and adverse scheduling could have a material adverse effect on the commercial attractiveness of such product. We or any partners must also obtain separate state registrations, permits or licenses in order to be able to obtain, handle, and distribute controlled substances for clinical trials or commercial sale, and failure to meet applicable regulatory requirements could lead to enforcement and sanctions by the states in addition to those from the DEA or otherwise arising under federal law.

	●	Clinical trials. Because some of our current and future product candidates contain Schedule I controlled substances, to conduct clinical trials in the United States prior to approval, each of our research sites must submit a research protocol to the DEA and obtain and maintain a DEA researcher registration that will allow those sites to handle and dispense such product candidates and to obtain the product from our importer. If the DEA delays or denies the grant of a researcher registration to one or more research sites, the clinical trial could be significantly delayed, and we could lose clinical trial sites.

	●	Importation. If any of our product candidates is approved and classified as a Schedule II, III or IV substance, an importer can only import it for commercial purposes if it obtains an importer registration and files an application for an import permit for each import. The DEA provides annual assessments/estimates to the International Narcotics Control Board, which guides the DEA in the amounts of controlled substances that the DEA authorizes to be imported. The failure to identify an importer or obtain the necessary import authority, including specific quantities, could affect the availability of our product candidates and have a material adverse effect on our business, results of operations and financial condition. In addition, an application for a Schedule II importer registration must be published in the Federal Register, and there is a waiting period for third-party comments to be submitted. It is always possible that adverse comments may delay the grant of an importer registration.

	●	Manufacture. If, because of a Schedule II classification or voluntarily, we were to conduct manufacturing or repackaging/relabeling in the United States, our contract manufacturers would be subject to the DEA’s annual manufacturing and procurement quota requirements.

	●	Distribution. If any of our product candidates is approved for marketing and scheduled under Schedule II, III or IV, we would also need to identify wholesale distributors with the appropriate DEA registrations and authority to possess and distribute or dispense such products.

	●	delays in reaching a consensus with regulatory authorities on trial design;

	●	delays in reaching agreement on acceptable terms with prospective contract research organization (“CRO”) and clinical trial sites;

	●	delays in sourcing materials and research animals for preclinical testing and correlated testing windows at the appropriate CRO facilities;

	●	delays in opening clinical trial sites or obtaining required IRB or independent ethics committee approval at each clinical trial site;

	●	actual or perceived lack of effectiveness of any product candidate during clinical trials;

	●	discovery of serious or unexpected toxicities or side effects experienced by trial participants or other safety issues, such as drug interactions, including those which cause confounding changes to the levels of other concomitant medications;

	●	slower than expected rates of subject recruitment and enrollment rates in clinical trials;

	●	difficulty in retaining subjects for the entire duration of applicable clinical studies (as study subjects may withdraw at any time due to adverse side effects from the therapy, insufficient efficacy, fatigue with the clinical trial process or for any other reason;

	●	delays or inability in manufacturing or obtaining sufficient quantities of materials for use in clinical trials due to regulatory and manufacturing constraints;

	●	inadequacy of or changes in our manufacturing process or product candidate formulation;

	●	delays in obtaining regulatory authorizations, such as INDs and any others that must be obtained, maintained, and/or satisfied to commence a clinical trial, including “clinical holds” or delays requiring suspension or termination of a trial by a regulatory agency, such as the FDA, before or after a trial is commenced;

	●	changes in applicable regulatory policies and regulation, including changes to requirements imposed on the extent, nature or timing of studies;

	●	delays or failure in reaching agreement on acceptable terms in clinical trial contracts or protocols with prospective clinical trial sites;

	●	uncertainty regarding proper dosing;

	●	delay or failure to supply product for use in clinical trials which conforms to regulatory specification;

	●	unfavorable results from ongoing preclinical studies and clinical trials;

	●	failure of our CROs, or other third-party contractors to comply with all contractual requirements or to perform their services in a timely or acceptable manner;

	●	failure by us, our employees, our CROs or their employees to comply with all applicable FDA or other regulatory requirements relating to the conduct of clinical trials;

	●	scheduling conflicts with participating clinicians and clinical institutions;

	●	failure to design appropriate clinical trial protocols;

	●	regulatory concerns with psychedelics, generally, and the potential for abuse;

	●	insufficient data to support regulatory approval;

	●	inability or unwillingness of medical investigators to follow our clinical protocols;

	●	difficulty in maintaining contact with patients during or after treatment, which may result in incomplete data;

	●	any clinical holds placed on company by regulatory agencies during review process;

	●	delay or failure to supply psychedelic product for use in clinical trials due to cross-border or inter-continental shipment or customs handling and processing of controlled substances; or

	●	difficulty finding clinical trials sites whose investigators possess the requisite credentials to oversee clinical trials involving a Schedule I substance.

	●	issue warning letters;

	●	impose civil or criminal penalties;

	●	suspend regulatory approval;

	●	suspend any of our ongoing clinical trials;

	●	refuse to approve pending applications or supplements to approved applications submitted by us;

	●	impose restrictions on our operations, including by requiring us to enter in to a Corporate Integrity Agreement or closing our contract manufacturers’ facilities, if any; or

	●	seize or detain products or require a product recall.

	●	regulatory authorities may interrupt, delay or halt clinical trials;

	●	regulatory authorities may deny regulatory approval of our future product candidates;

	●	regulatory authorities may require certain labeling statements, such as warnings or contraindications or limitations on the indications for use, and/or impose restrictions on distribution in the form of a Risk Evaluation and Mitigation Strategy (“REMS”) in connection with approval or post-approval;

	●	regulatory authorities may withdraw their approval, require more onerous labeling statements, impose a more restrictive REMS, or require it to recall any product that is approved;

	●	we may be required to change the way the product is administered or conduct additional clinical trials;

	●	our relationships with our collaboration partners may suffer;

	●	we could be sued and held liable for harm caused to patients; or

	●	our reputation may suffer. The reputational risk is heightened with respect to those of our future product candidates that are being developed for pediatric indications.

	●	the announcement of new products, new developments, services or technological innovations by us or our competitors;

	●	actual or anticipated quarterly increases or decreases in revenue, gross margin or earnings, and changes in our business, operations or prospects;

	●	announcements relating to strategic relationships, mergers, acquisitions, partnerships, collaborations, joint ventures, capital commitments, or other events by us or our competitors;

	●	conditions or trends in the life sciences and biopharma industries;

	●	changes in the economic performance or market valuations of other life sciences and biopharma companies;

	●	general market conditions or domestic or international macroeconomic and geopolitical factors unrelated to our performance or financial condition;

	●	sale of our common stock by stockholders, including executives and directors;

	●	volatility and limitations in trading volumes of our common stock;

	●	volatility in the market prices and trading volumes of companies in the life sciences and biopharma industries;

	●	our ability to finance our business;

	●	ability to secure resources and the necessary personnel to pursue our plans;

	●	failures to meet external expectations or management guidance;

	●	changes in our capital structure or dividend policy, future issuances of securities, sales or distributions of large blocks of common stock by stockholders;

	●	our cash position;

	●	announcements and events surrounding financing efforts, including debt and equity securities;

	●	analyst research reports, recommendation and changes in recommendations, price targets, and withdrawals of coverage;

	●	departures and additions of key personnel;

	●	disputes and litigation related to intellectual properties, proprietary rights, and contractual obligations;

	●	investigations by regulators into our operations or those of our competitors;

	●	changes in applicable laws, rules, regulations, or accounting practices and other dynamics; and

	●	other events or factors, many of which may be out of our control.

	●	a limited availability of market quotations for our securities;

	●	a determination that our common stock is a “penny stock” which will require brokers trading in our common stock to adhere to more stringent rules and possibly result in a reduced level of trading activity in the secondary trading market for our securities;

	●	a limited amount of news and analyst coverage for our Company; and

	●	a decreased ability to issue additional securities (including pursuant to short-form registration statements on Form S-3 or obtain additional financing in the future).

	●	employee-related expenses, including salaries, benefits and share-based compensation expense;

	●	expenses incurred under agreements with contract research organizations, contract manufacturing organizations, and consultants and other entities engaged to support our product research and development activities;

	●	the cost of acquiring, developing and manufacturing materials and lab supplies used in research and development activities;

	●	facility, equipment, depreciation and other expenses, which include, without limitation direct and allocated expenses for rent, maintenance of our facilities and equipment, insurance and other supplies;

	●	costs associated with preclinical activities and regulatory operations, including, without limitation, patent related costs;

	●	consulting and professional fees associated with research and development activities.

	For the Years Ended December 31,
	2023			2022
Operating expenses
General and administrative	$	8,852,021		$	11,605,761
Research and development		7,252,437			8,027,773
Impairment of intangible assets and goodwill		—			7,453,662
Depreciation and amortization		343,982			327,910
Total operating expenses		16,448,440			27,415,106

Loss from operations		(16,448,440	)		(27,415,106	)

Other (expense) income
Inducement expense, net		(1,848,235	)		—
Change in fair value of warrant liabilities		94,396			4,315,236
Change in fair value of investment option liability		208,752			3,472,726
Change in fair value of derivative liability		727,000			(325,000	)
Interest income (expense), net		3,708			(5,249	)
Total other (expense) income		(814,379	)		7,457,713

Net loss before income taxes	$	(17,262,819	)	$	(19,957,393	)

Income tax (expense) benefit		(28,913	)		1,486,060

Net loss	$	(17,291,732	)	$	(18,471,333	)

	●	We were unable to document, formalize, implement and revise where necessary controls, policies and procedure documentation to evidence a system of controls, including testing of such controls that is consistent with our current personnel and available resources;

	●	We failed to document, maintain and test effective control activities over our control environment, risk assessment, information technology and monitoring components;

	●	We had insufficient segregation of duties, oversight of work performed and lack of compensating controls in our finance and accounting functions, including, without limitation, the processing, review and authorization of all routine and non-routine transactions, due to limited personnel and resources.

	●	We engaged third party subject matter experts to assist in the design and documentation of an internal control environment meeting those requirements and criteria established in the COSO 2013 Internal Control Integrated Framework;

	●	We engaged information technology experts who designed and implemented a secure, cloud based, server and IT environment with controlled access, monitoring, help desk and a user training protocol;

	●	We installed and implemented third party software that provides improved control, approvals and segregation of duties over the purchase to pay operation cycle;

	●	We engaged third party subject matter experts who are providing independent supervision of accounting staff, transaction processing, reconciliations and financial statement preparation, resulting in improved segregation of duties;

Reports of Independent Registered Accounting Firm (PCAOB Firm ID: Marcum LLP #688)	F-1
Consolidated Balance Sheets	F-2
Consolidated Statements of Operations and Comprehensive Loss	F-3
Consolidated Statements of Changes in Mezzanine Equity and Shareholders’ Equity	F-4
Consolidated Statements of Cash Flows	F-6
Notes to Consolidated Financial Statements	F-7

Exhibit No.		Description

2.1		Share Purchase Agreement, dated January 10, 2020, by and between AMERI Holdings, Inc. and Ameri100, Inc. (incorporated by reference to Exhibit 2.1 to the Company’s Current Report on Form 8-K, filed with the Commission on January 13, 2020)

2.2		Tender Offer Support Agreement and Termination of Amalgamation Agreement, dated August 12, 2020, by and among AMERI Holdings, Inc., Jay Pharma Merger Sub, Inc., Jay Pharma Inc., 1236567 B.C. Unlimited Liability Company and Barry Kostiner, as the Ameri representative (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K, filed with the Commission on August 12, 2020)

2.3		Amendment No. 1 To Tender Offer Support Agreement and Termination of Amalgamation Agreement, dated December 18, 2020, by and among Ameri, Jay Pharma Merger Sub, Inc., Jay Pharma Inc., 1236567 B.C. Unlimited Liability Company and Barry Kostiner, as the Ameri representative (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K, filed with the Commission on December 18, 2020)

2.4		Amalgamation Agreement, dated May 24, 2021, by and among Enveric Biosciences, Inc., 1306432 B.C. LTD., 1306436 B.C. LTD., and MagicMed Industries, Inc. (incorporated by reference to Exhibit 2.1 to the Company’s Current Report on Form 8-K, filed with the Commission on May 24, 2021)

3.1		Certificate of Amendment to Amended and Restated Certificate of Incorporation of Enveric Biosciences, Inc. (incorporated by reference to Exhibit 3.2 to the Company’s Current Report on Form 8-K, filed with the Commission on January 6, 2021)

3.2		Certificate of Designations of Series B Preferred Stock of Enveric Biosciences, Inc. (incorporated by reference to Exhibit 3.3 to the Company’s Current Report on Form 8-K, filed with the Commission on January 6, 2021)

3.3		Amended and Restated Bylaws of Enveric Biosciences, Inc. (incorporated by reference to Exhibit 3.4 to the Company’s Current Report on Form 8-K, filed with the Commission on January 6, 2021)

3.4		Amendment to the Amended and Restated Bylaws of Enveric Biosciences, Inc. (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K, filed with the Commission on November 18, 2021)

3.5		Certificate of Designation of the Series C Preferred Stock of the Company, dated May 4, 2022 (incorporated by reference to Exhibit 3.1 to the Company’s Registration Statement on Form 8-A, filed with the Securities and Exchange Commission on May 4, 2022, File No. 000-26460)

3.6		Certificate of Amendment of Certificate of Designation of the Series C Preferred Stock of the Company, dated May 17, 2022 (incorporated by reference to Exhibit 3.2 to the Company’s Registration Statement on Form 8-A/A, filed with the Securities and Exchange Commission on May 17, 2022, File No. 000 26460)

3.7		Certificate of Amendment of Amended and Restated Certificate of Incorporation of Enveric Biosciences, Inc. (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K, filed with the Commission on July 14, 2022)

4.1		Description of Securities (incorporated by reference to Exhibit 4.1 of the Company’s Annual Report on Form 10-K, filed with the Securities and Exchange Commission on March 31, 2023)

4.2		Form of Pre-Funded Warrant (issued in connection with January 2021 Registered Direct Offering) (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K, filed with the Commission on January 12, 2021)

4.3		Form of Warrant (issued in connection with January 2021 Registered Direct Offering) (incorporated by reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K, filed with the Commission on January 12, 2021)

4.4		Form of Warrant (issued in connection with February 2021 Registered Direct Offering) (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K, filed with the Commission on February 11, 2021)

4.5		Form of Series B Warrant (incorporated by reference to Exhibit 4.5 to the Company’s Annual Report on Form 10-K filed with the Commission on April 1, 2021)

4.6		Form of MagicMed Warrant Certificate (incorporated by reference to Exhibit 4.1 of the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on September 17, 2021)

4.7		Form of Common Stock Purchase Warrant (in connection with February 2022 Offering) (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K, filed with the Commission on February 15, 2022)

4.8		Form of RD Pre-Funded Warrant (in connection with July 2022 Offering) (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K, filed with the Commission on July 26, 2022)

4.9		Form of PIPE Pre-Funded Warrant (in connection with July 2022 Offering) (incorporated by reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K, filed with the Commission on July 26, 2022)

4.10		Form of RD Preferred Investment Option (in connection with July 2022 Offering) (incorporated by reference to Exhibit 4.3 to the Company’s Current Report on Form 8-K, filed with the Commission on July 26, 2022)

4.11		Form of PIPE Preferred Investment Option (in connection with July 2022 Offering) (incorporated by reference to Exhibit 4.4 to the Company’s Current Report on Form 8-K, filed with the Commission on July 26, 2022)

4.12		Form of Wainwright Warrant (in connection with July 2022 Offering) (incorporated by reference to Exhibit 4.5 to the Company’s Current Report on Form 8-K, filed with the Commission on July 26, 2022)

4.13		Form of Inducement Warrant (in connection with December 2023 Offering) (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K, filed with the Commission on December 29, 2023)

10.1		Employment Agreement between Kevin Coveney and the Company, effective March 13, 2023 (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K, filed with the Commission on February 28, 2023)

10.2		Form of Securities Purchase Agreement (entered into in connection with the May 5, 2022 Private Placement) (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K, filed with the Commission on May 11, 2022)

10.3		Certificate of the Designations, Preferences and Rights of Akos Series A Convertible Preferred Stock (incorporated by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K, filed with the Commission on May 11, 2022)

10.4		Form of Registration Rights Agreement (entered into in connection with the May 5, 2022 Private Placement) (incorporated by reference to Exhibit 10.3 to the Company’s Current Report on Form 8-K, filed with the Commission on May 11, 2022)