What changed in this filing

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Item 1. Business

2025-03-28 compared with 2024-03-26 · 222 added, 269 removed, 605 unchanged (45% of the section changed)

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company immediately prior to the completion of a “reverse merger” transaction on May 26, 2015, whereby Ameri100 Acquisition,

Inc., a Delaware corporation and newly created, wholly owned subsidiary, was merged with and into Ameri and Partners Inc.

and Partners”), a Delaware corporation (the “2015 Merger”).

In connection with the 2015 Merger, we changed our name

to AMERI Holdings, Inc.

Inc., a Delaware corporation and newly created, wholly owned subsidiary, was merged with and into Ameri and Partners Inc., a Delaware

corporation (the “2015 Merger”).

In connection with the 2015 Merger, we changed our name to “AMERI Holdings, Inc.”

Ameri business ceased to be part of the Company on December 30, 2020, pursuant to a spin-off transaction.

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a tender offer to purchase all of the outstanding common shares of Jay Pharma Inc., a Canada corporation, for shares of Company common

stock or certain preferred stock (the “Offer”), and changed our name to “Enveric Biosciences, Inc.” Our principal

corporate office is located at Enveric Biosciences, Inc., 4851 Tamiami Trail N, Suite 200, Naples, Florida 34103, telephone (239) 302-1707.

Our internet address is https://www.enveric.com/, and the information included in, or linked to our website is not part of this Annual

Report on Form 10-K.

We have included our website address in this Annual Report on Form 10-K solely as a textual reference.

stock or certain preferred stock, and changed our name to “Enveric Biosciences, Inc.”

May 24, 2021, the Company entered into an Amalgamation Agreement (the “Amalgamation Agreement”) with 1306432 B.C.

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in exchange for securities of the Company by way of an amalgamation under the British Columbia Business Corporations Act, upon the terms

and conditions set forth in the Amalgamation Agreement, such that, upon completion of the Amalgamation (as defined herein), the amalgamated

corporation (“Amalco”) became an indirect wholly-owned subsidiary of the Company.

and conditions set forth in the Amalgamation Agreement, such that, upon completion of the amalgamation, the amalgamated corporation (“Amalco”)

became an indirect wholly-owned subsidiary of the Company.

The amalgamation was completed on September 16, 2021.

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.

March 21, 2023, the Company established Enveric Therapeutics Pty.

Ltd., an Australia-based subsidiary (“Enveric Therapeutics”),

to support the Company’s plans to advance the EVM201 Series, comprised of the next generation synthetic prodrugs of the active

metabolite, psilocin, towards the clinic.

Enveric Therapeutics was established to oversee the Company’s intended preclinical, clinical,

and regulatory activities in Australia, including interactions with the local Human Research Ethics Committees (“HREC”) and

the Therapeutic Goods Administration, Australia’s regulatory authority.

Enveric has since out-licensed the EVM201 Series asset

to MycoMedica Life Sciences, Inc.

and is not currently performing activities in Australia.

are required to file Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q with the Securities and Exchange Commission (the

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as soon as reasonably practicable after those reports and other information is electronically filed with, or furnished to, the SEC.

internet address is https://www.enveric.com/, and the information included in, or linked to our website is not part of this Annual Report

on Form 10-K.

We have included our website address in this Annual Report on Form 10-K solely as a textual reference.

are a biotechnology company dedicated to the development of novel neuroplastogenic small-molecule therapeutics for the treatment of depression,

anxiety, and addiction disorders.

Leveraging our unique discovery and development platform, The Psybrary™, we have created a robust

intellectual property portfolio of new chemical entities for specific mental health indications.

Our lead program, the EVM201 Series,

comprises next generation synthetic prodrugs of the active metabolite, psilocin.

We are developing the first product from the EVM201

Series – EB-002 – for the treatment of psychiatric disorders.

We are also advancing its second program, the EVM301 Series

– EB 003 – expected to offer a first-in-class, new approach to the treatment of difficult-to-address mental health disorders,

mediated by the promotion of neuroplasticity without also inducing hallucinations in the patient.

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 anxiety.

We synthesize novel versions of classic psychedelics,

such as psilocybin, N,N-Dimethyltryptamine (“DMT”), mescaline and MDMA, using a mixture of chemistry and synthetic biology, resulting in

the expansion of the Psybrary™, which includes 15 patent families with over a million potential variations and hundreds of synthesized

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 has created over 1,000 novel psychedelic molecular compounds and derivatives (“Psychedelic

Derivatives”) that are housed in the Psybrary™.

Our current focus is develop our lead molecules EB-002 and EB-003 and to

out-license other molecules from the Psybrary™.

May 11, 2022, the Company announced plans to transfer and spin-off its cannabinoid clinical development pipeline assets to Akos Biosciences,

(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.

pipeline of product candidates and key ongoing development programs are shown in the tables below:

Second-generation

psychedelic asset:

prodrug of psilocin

of HREC for FIH study in Australia

Third-generation

psychedelic-inspired new chemical entity

health indication

are a party to certain license agreements as described below, and going forward we intend to both develop intellectual property and license

intellectual property from pharmaceutical and biotechnology companies and research institutions which would cover research stage and

clinical stage assets to build a pipeline of product candidates.

current focus of Enveric’s intellectual property is in psychedelics, including multiple portfolios of psychedelic-inspired compounds

anxiety, addiction, and other psychiatric disorders.

Leveraging our unique discovery and development platform, the Psybrary™, which

houses proprietary information on the use and development of existing and novel molecules for specific mental health indications, Enveric

seeks to develop a robust intellectual property portfolio of novel drug candidates.

lead program, the EVM301 Series, and its lead drug candidate, EB-003, are intended to offer a first-in-class, new approach to the treatment

of difficult-to-address mental health disorders, mediated by the promotion of neuroplasticity and without also inducing hallucinations

in the patient.

Enveric unveiled its EVM401 Series on February 25, 2025, which is intended to broaden Enveric’s pipeline with additional

non-hallucinogenic molecules and strengthen its ability to target addiction and neuropsychiatric disorders for patients with limited

Previously, Enveric was developing the EVM201 Series, and its lead drug candidate EB-002 (formerly EB-373), for the treatment

of neuropsychiatric disorders.

The EVM201 Series comprised next generation synthetic prodrugs of the active metabolite, psilocin.

Enveric out-licensed the EVM201 Series program to MycoMedica Life Sciences, who will seek to develop, manufacture, and commercialize

EB-002, in exchange for certain development and milestone payments to Enveric.

Neuroplastogens

our amalgamation with MagicMed in September 2021, we have continued to pursue the development of MagicMed’s proprietary library,

the Psybrary™, which we believe will help us to identify and develop the right drug candidates needed to address mental health

challenges, including depression, anxiety, and addiction disorders.

We synthesize novel phenylalkylamines and indolethylamines, using

a mixture of chemistry and synthetic biology, resulting in the expansion of the Psybrary™, which currently includes 20 patent families

with claims covering a million potential molecular structures, over one thousand of which we have so far synthesized in sufficient quantities

to identify and hundreds of which we have screened for receptor binding and other relevant activities.

Company developed certain intellectual property rights around the trademark PsyAI™ for potential use.

On March 6, 2025, Enveric

announced it is soliciting Requests-For Proposals (“RFPs”) for the license or sale of its PsyAI™ trademark portfolio

as a means of maximizing value for an asset which is no longer strategic given the Company’s focus on drug development.

portfolio of US and Canadian trademark assets is held by its subsidiary, Enveric Biosciences Canada, Inc.

Enveric expects the period

for RFPs to remain open until August 31, 2025, with a decision to follow within three (3) months thereafter.

this stage, we have entered into several non-binding term sheets with strategic partners to out-license certain molecules from the Psybrary™.

Going forward, in order to build a pipeline of product candidates, we intend to both continue to internally develop new drug candidates

with associated intellectual property and to acquire, through in-licensing, additional intellectual property from pharmaceutical and

biotechnology companies and research institutions.

The in-licensed assets could include both research stage and clinical stage drug candidates.

we intend to pursue development of the EVM401 Series, our primary focus is to develop our lead asset EB-003 in the EVM301 Series.

development status of EB-003 is shown in the table below:

Product Candidates

Targeted Indications

Expected Next Steps

Mental health indication

Preclinical Development

Psychedelic-inspired drug candidate

are a party to certain license agreements as described below, to build a pipeline of product candidates going forward, we intend to both

continue to internally develop new drug candidates with associated intellectual property and to acquire, through in-licensing, additional

intellectual property from pharmaceutical and biotechnology companies and research institutions.

The in-licensed assets could include

both research stage and clinical stage drug candidates.

current focus of Enveric’s intellectual property is in neuroplastogens, including multiple portfolios of psychedelic-inspired compounds

and formulations and methods of making, using, and treating mental and neurological disorders.

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property related to computer assisted methods of discovering promising novel psychedelic-inspired compounds.

The Enveric intellectual

property estate includes several portfolios of cannabinoid-related patents and patent applications related to the treatment of pain and

treatment of cancer.

own full rights to 22 patent families related to psychedelic inspired compounds.

Derivatives .

A portfolio of ten patent families, represented by five United States patents and 33 pending United States and non-United

States patent applications, related to psilocybin derivatives, methods of making psilocybin derivatives, and methods for treatment of

mental disorders, such as anxiety, post-traumatic-stress disorder (“PTSD”), and other psychiatric conditions.

A portfolio of four patent families, represented by three United States patents, three pending United States applications,

and four pending Patent Cooperation Treaty (“PCT”) applications related to prodrugs of psilocin.

Derivatives – EVM 501 Series.

A portfolio of four patent families represented by four pending United States patent applications

and four PCT applications related to mescaline derivatives and methods of treatment using mescaline derivatives.

Derivatives – EVM 401 Series .

A portfolio of four patent families represented by four pending PCT applications related to MDMA

derivatives and methods of treatment using MDMA derivatives.

portfolios include the following published and unpublished applications:

These ten patent families include applications and patents related to different psilocybin derivative compounds, methods

for making the compounds, methods for modulating a 5-HT2A cell surface receptor, and methods for treating psychiatric disorders:

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

Psilocybin Derivatives and Methods of Using (WO2022047579)

Psilocybin Derivatives and Methods of Using (WO2022047580)

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

Psilocybin Derivatives and Methods of Using (WO2023044556A1)

Psilocybin Derivatives and Methods of Using (WO2022104475A1)

Psilocybin Derivatives and Methods of Using (WO2022115944)

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

Psychedelic-Inspired

own rights to 20 active patent families related to compounds that are phenylalkylamine and indolethylamine derivatives.

The 20 patent

families are represented by a total of 17 issued United States patents and 47 pending United States and non-United States patent applications

for treatment of mental disorders, such as depression, anxiety, addiction, and other neuropsychiatric conditions.

patent portfolio includes the following published and unpublished applications:

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

Multi-substituent

Halogenated Psilocybin

Derivatives and Methods of Using (WO2022/047579)

Hydroxylated Psilocybin

Derivatives and Methods of Using (WO2022/047580)

Nitrated Psilocybin

Derivatives and Methods of Using (WO 2022/047583)

Aminated Psilocybin

Derivatives and Methods of Using (WO2023/044556)

Nitrilated Psilocybin

Derivatives and Methods of Using (WO2022/104475)

Psilocybin Derivatives and Methods of Using (WO2022/115944)

These four patent families include applications and patents related to novel tryptamine derivative compounds which serve

as prodrugs for psilocin, and methods for making and using the prodrugs for treatment of psychiatric disorders.

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

Carboxylic Acid Substituted Tryptamine Derivatives and Methods of Using (WO2023/173196A1)

Carbanothioate Substituted Tryptamine Derivatives and Methods of Using (WO 2023/173197)

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

Derivatives – EVM 501 Series.

These four patent families include applications related to novel mescaline derivative compounds

and pharmaceutical formulations, methods for making and using those compounds and formulations, and methods for treating a neurological

One is published, and three are currently unpublished PCT applications.

Heterocyclic Mescaline Derivatives ( WO2024026568A1)

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

and PCT/CA2023/051670

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

Derivatives – EVM 401 Series.

These four patent families include applications related to novel mescaline derivative compounds

and pharmaceutical formulations, methods for making and using those compounds and formulations, and methods for treating a neurological

One is published, and three are currently unpublished PCT applications.

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)

Assisted Drug Discovery

Implemented Methods and Systems for Identifying Tryptamine Derivative Compounds Capable of Interacting with a 5-HT2A Receptor (Provisional

patent application)

own rights to six families of cannabinoid-related intellectual property.

All cannabinoid-related technology, intellectual property, and

agreements are held by Enveric’s subsidiary, Akos Biosciences, Inc.

The Akos cannabinoid portfolios have three focus areas:

molecules for the treatment of pain;

cancer treatment comprising combination treatment;

and topical creams for treating the effects of

cancer radiation.

Cannabinoid-Conjugates .

A portfolio of three patent families discloses and variously claims novel conjugate molecules of cannabinoids linked with either COX-2

inhibitors or steroids for treatment of pain, osteoarthritis, rheumatoid arthritis, and other diseases.

Two patent families in-licensed

from Diverse Biotech (see detail below) comprise of one United States patent and twelve pending United States and non-United States patent

applications.

The third and wholly owned patent family comprises two United States patents, four pending United States and non-United

States patent applications, and one pending PCT application.

Conjugate Molecules (WO2020263888A1) (In-licensed)

Molecules (WO2021076197A1) (In-licensed)

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

A portfolio of two patent families addresses the treatment of cancer using a combination of a cannabinoid and a chemotherapeutic

The two patent families are represented by one United States patent and five pending United States and non-United States patent

Aldehyde and Ketone

Derivatives of Psilocybin and Methods of Using (WO2022/115960)

Prenylated Psilocybin

Derivatives and Methods of Using (WO2022/155751)

Multi-substituent Psilocybin

Derivatives and Methods of Using (WO2022/170438)

N-Heterocycle Substituted

Tryptamine Derivatives and Methods of Using (Unpublished PCT/CA2024/050312)

Tri-Halo-Alkoxy-Substituted

Tryptamine Derivatives (Unpublished PCT/CA2024/050242)

C-4 Substituted Tryptamine

Derivatives and Methods of Using (WO2023/173227)

C-4 Carboxylic Acid

Substituted Tryptamine Derivatives and Methods of Using (WO2023/173196)

C-4 Carbanothioate Substituted

Tryptamine Derivatives and Methods of Using (WO2023/173197)

Salts of C4-Carboxylic

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

Fused Heterocyclic Mescaline

Derivatives ( WO2024/026568A1)

C1-Substituted Isopropylamine

Fused Heterocyclic Mescaline Derivatives (WO2024/086933)

Substituted N- Propylamine

Fused Heterocyclic Mescaline Derivatives (WO2024/103185)

Substituted Ethylamine

Fused Heterocyclic Mescaline Derivatives (WO2024/124353)

Conjugates and Formulations

own rights held by our wholly-owned subsidiary Akos Biosciences, Inc.

to 2 active patent families related to cannabinoids.

family relates to cannabinoid crème formulations for treatment of radiation dermatitis and is licensed to Aries Science &

Technology, LLC, and comprises 1 United States patent and 2 pending non-United States patents applications.

The other patent family relates

to cannabinoid conjugates in combination with COX-2 inhibitors for treatment of pain and joint disease and is the subject of a pending

license term sheet with a third party and comprises 3 United States patents, and 3 pending United States and non-United States patent

applications.

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

A portfolio comprising a single patent family focuses on cremes for the treatment of radiation dermatitis, a frequent

side effect of cancer treatment which needs a higher standard of care for patients.

The patent family includes one pending United States

patent application and one pending PCT application.

for Topical Treatment of Radiation Dermatitis (WO2023154264A1)

for topical treatment of radiation dermatitis (WO2023154264)

Cannabinoid Conjugate

Molecules (WO2023150057)

Biotech, Inc.

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in-licensed Diverse Biotech, Inc.

portfolio includes two patent families comprising one issued and 12 pending national applications.

patents and applications disclose conjugate chemistry that combines cannabinoids with existing drugs in conjugate form that we believe

will provide differentiation in use and efficacy from combination therapy of drugs and cannabinoids.

The license extends for as long

as Enveric intends to develop and commercialize the licensed Agents and Products.

The patent applications, should they issue, may expire

as late as 2040.

portfolio includes two patent families comprising 2 issued United States patents and 13 pending United

States and non-United States applications.

Those patents and applications disclose conjugate chemistry that combines cannabinoids with

existing drugs in conjugate form that we believe will provide differentiation in use and efficacy from combination therapy of drugs and

cannabinoids.

The license extends for as long as Enveric intends to develop and commercialize the licensed Agents and Products.

applications, should they issue, may expire as late as 2040.

& Development

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neurologic disorders.

are currently pursuing drug discovery and pre-clinical activities in order to advance a number of novel psychedelic-inspired molecules

are currently pursuing drug discovery and preclinical activities in order to advance a number of novel psychedelic-inspired molecules

towards the clinic.

Enveric’s lead programs are EB-002 and EB-003.

EB-002 is a next generation prodrug of psilocin, the active

metabolite of psilocybin.

It is the lead drug candidate from the EVM201 Series currently advancing through preclinical development with

the aim of initiating first-in-human studies, followed by clinical trials targeting the treatment of anxiety disorders.

EB-003 is a next

generation analog of DMT.

It is the lead drug candidate from the EVM301 Series currently advancing through preclinical

development with the aim of initiating first-in-human studies, followed by clinical trials targeting the treatment of depression disorders.

intend to assemble a team of principal investigators with clinical experience across multiple mental health and central nervous system

indications to be responsible for the management, monitoring, and integrity of the clinical research.

plan to submit filings with regulatory agencies including Clinical Trial Applications (“CTA”), Investigational New Drug (“IND”)

applications and, eventually, new drug applications (“NDA”) to seek approval with the US FDA and other jurisdictions, in

connection with our product candidates.

The selection, timing, duration, and design of any prospective studies are subject to regulatory

filings, approval and finalization of commercial plans.

March 23, 2023, we issued a press release announcing the selection of Australian CRO, Avance Clinical, in preparation for Phase 1 Study

of EB-002, our lead candidate targeting the treatment of anxiety disorders.

Under the agreement, Avance Clinical will manage the Phase

1 clinical trial of EB-002 in coordination with our newly established Australian subsidiary, Enveric Therapeutics Pty, Ltd.

1 clinical trial is designed as a multi-cohort, dose-ascending study to measure the safety and tolerability of EB-002.

EB-002, a next-generation

proprietary psilocin prodrug, has been recognized as a New Chemical Entity (“NCE”) by Australia’s TGA and is currently

in preclinical development targeting the treatment of anxiety disorder.

December 28, 2023, we issued a press release announcing the selection of EB-003 as the lead development candidate from our EVM 301 Series.

Our next step is to advance EB-003 into formal pre-clinical studies in support of a future IND filing.

Enveric’s lead development candidate is EB-003.

EB-003 is a novel derivative of DMT.

It is the lead drug candidate

from the EVM301 Series currently advancing through preclinical studies with the aim of initiating first-in-human studies to assess safety

and tolerability including non-hallucinogenic properties, followed by clinical trials targeting the treatment of depression or other

neuropsychiatric disorders.

intend to assemble a team of clinical experts and principal investigators with experience across multiple mental health and central nervous

system indications to be responsible for the management, monitoring, and integrity of the clinical research.

plan to submit filings including Clinical Trial Applications (“CTA”), Investigational New Drug (“IND”) applications

and, eventually, new drug applications (“NDA”) to seek approval with the US FDA and with responsible regulatory agencies

in other jurisdictions, in connection with our product candidates.

The selection, timing, duration, and design of any prospective studies

are subject to regulatory filings, approval and finalization of commercial plans.

next step is to advance EB-003 into formal preclinical development studies in support of a future IND filing.

Advisory Board

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of Psychopharmacology for the California Department of State Hospitals

DeWitt, Ph.D.

President & CEO of DeuteRx, LLC;

COO of Neuromity Therapeutics, Inc.;

Founder of RIFFIT, Inc.

Therapeutics R&D

Krystal, M.D.

of Yale Center for Clinical Investigation

Liebowitz, M.D.

of Psychiatry;

Director at Medical Research Network

has served as a Scientific Advisor of Enveric since 2022.

Fava is Psychiatrist-in-Chief of the Massachusetts General Hospital (“MGH”), executive director of the Clinical Trials Network

and Institute, associate dean for clinical and translational research, and the Slater Family Professor of Psychiatry at Harvard Medical

Maurizio Fava is Chair, Mass General Brigham Academic Centers

Psychiatry Department, Psychiatrist-in-Chief of the Massachusetts General Hospital (MGH), executive director of the Clinical Trials Network

and Institute, (MGH), associate dean for clinical and translational research, and the Slater Family Professor of Psychiatry at Harvard

Medical School.

Fava is a world leader in the field of depression.

He has edited eight books and authored or co-authored more than 900 original

articles published in medical journals with international circulation, articles which have been cited more than 95,000 times in the literature

and with an H index greater than 150.

Fava founded and was director of MGH’s Depression Clinical and Research Program from 1990

Fava’s direction, the Depression Clinical and Research Program became one of the most highly regarded depression

programs in the country, a model for academic programs that link, in a bi-directional fashion, clinical and research work.

also founded and is now the executive director of the MGH Psychiatry Clinical Trials Network and Institute, the first academic CRO specialized

in the coordination of multi-center clinical trials in psychiatry.

He has edited eight books and authored or co-authored more than

900 original articles published in medical journals with international circulation, articles which have been cited more than 95,000 times

in the literature and with an H index greater than 150.

Fava founded and was director of MGH’s Depression Clinical and Research

Program from 1990 until 2014.

Fava’s direction, the Depression Clinical and Research Program became one of the most highly

regarded depression programs in the country, a model for academic programs that link, in a bi-directional fashion, clinical and research

In 2007, he also founded and is now the executive director of the MGH Psychiatry Clinical Trials Network and Institute, the first

academic CRO specialized in the coordination of multi-center clinical trials in psychiatry.

Stahl, M.D., Ph.D.

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edition, and the best-selling and award-winning clinical manual, Essential Psychopharmacology Prescriber’s Guide, now in its seventh

has served as a Scientific Advisor of Enveric since 2022.

Sheila DeWitt is a Life Sciences Executive & Serial

Entrepreneur with over 30 years of experience in pharmaceutical and biotechnology companies.

She is currently the Chair, President &

CEO of DeuteRx, LLC, the COO and Board Member of Neuromity Therapeutics, Inc., and a Founder and Board Member of RIFFIT, Inc.

collaborates with Poxel SA and Salarius Therapeutics, Inc.

on deuterated drug candidates.

DeWitt has founded and/or led the start-up

or turnaround of nine biotechnology companies or business units.

DeWitt earned her B.A.

in Chemistry from Cornell University and

in Synthetic Organic Chemistry from Duke University.

She is internationally recognized for her pioneering contributions to pharmaceutical

R&D in the areas of combinatorial chemistry, predictive ADMET, nanotechnology, computational chemistry, and deuterated drugs and

has received numerous awards in recognition for her innovation and entrepreneurship.

She has authored over 60 publications and abstracts,

created and delivered over 20 short courses or symposia, and is an inventor on over 100 patents and/or patent applications.

Krystal, M.D.

has served as a Scientific Advisor of Enveric since 2022.

is the Robert L.

McNeil, Jr., Professor of Translational Research;

John Krystal is the Robert L.

McNeil, Jr., Professor

of Translational Research;

Professor of Psychiatry, Neuroscience, and Psychology;

Department of Psychiatry at Yale University;

Chair of the Department of Psychiatry at Yale University;

and Chief of Psychiatry and Behavioral Health at Yale-New Haven Hospital.

He is a graduate

of the University of Chicago, Yale School of Medicine, and the Yale Psychiatry Residency Training Program.

He has published extensively

on the neurobiology and treatment of schizophrenia, alcoholism, PTSD, and depression.

Notably, his laboratory discovered the rapid antidepressant

effects of ketamine in humans.

Krystal directs/co-directs the Yale Center for Clinical Investigation, NIAAA Center for the Translational

Neuroscience of Alcoholism, and Clinical Neuroscience Division of the National Center for PTSD (VA).

He is a graduate of the University of Chicago, Yale School

of Medicine, and the Yale Psychiatry Residency Training Program.

He has published extensively on the neurobiology and treatment of schizophrenia,

alcoholism, PTSD, and depression.

Notably, his laboratory discovered the rapid antidepressant effects of ketamine in humans.

directs/co-directs the Yale Center for Clinical Investigation (CTSA), NIAAA Center for the Translational Neuroscience of Alcoholism,

and Clinical Neuroscience Division of the National Center for PTSD (VA).

He is a member of the U.S.

Academy of Medicine;

co-director of the Neuroscience Forum of the U.S.

National Academy of Medicine;

of the Neuroscience Forum of the U.S.

National Academies of Sciences, Engineering, and Medicine;

of the American Association for the Advancement of Science;

and editor of Biological Psychiatry.

Fellow of the American Association for

the Advancement of Science (AAAS);

and editor of Biological Psychiatry (IF=13.382).

Previously, Dr.

Krystal chaired the NIMH

Board of Scientific Counselors and has served as a member of the NIMH National Mental Health Advisory Council and the NIAAA National Alcohol

Advisory Council.

He also previously served as the president of the American College of Neuropsychopharmacology and the International

College of Neuropsychopharmacology.

have also established relationships with certain academic partners, whom we believe have the potential to accelerate product development,

Krystal chaired the NIMH Board of

Scientific Counselors and has served as a member of the NIMH National Mental Health Advisory Council and the NIAAA National Alcohol Advisory

He also previously served as the president of the American College of Neuropsychopharmacology (ACNP) and the International College

of Neuropsychopharmacology (CINP).

Liebowitz, M.D.

has served as a Scientific Advisor of Enveric since 2022.

Michael Liebowitz is a Professor of Psychiatry at Columbia

University and New York State Psychiatric Institute (NYSPI) and is currently Director at Medical Research Network where he is engaged

in clinical trials for depression, anxiety, binge eating, ADHD, PTSD, and borderline personality disorders.

Liebowitz completed his

fellowship in psychopharmacology at the Depression Evaluation Service at NYSPI, where he helped develop and validate the DSM criteria

for atypical depression.

Liebowitz established the Anxiety Disorders Clinic at NYSPI, the first research clinic to specialize in

anxiety disorders in the United States.

Over the next two decades, Dr.

Liebowitz and colleagues helped refine treatments for panic disorder,

broadened the diagnostic criteria and established medication treatment for social anxiety disorder, and collaborated in clinical trials

comparing medications and behavioral treatments for several anxiety disorders.

Liebowitz developed the Liebowitz Social Anxiety Scale

(LSAS) which has been the primary outcome measure for several registration programs in social anxiety disorder and is used worldwide

as a research and clinical measure.

have also established relationships with certain academic partners, who we believe have the potential to accelerate our product development,

market entry, data collection, analysis and advancement of clinical trials.

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successfully develop and commercialize will compete with existing therapies and new therapies that may become available in the future.

intend to focus on the development of novel and viable Psychedelic Derivatives for mental illnesses and unmet medical needs, and partner

with pharmaceutical and other drug development and biotechnology companies in developing and commercializing psychedelic-derived drugs

for diverse psychological and neuropsychiatric indications, of which will be fundamentally composed of the Psychedelic Derivatives contained

in the Psybrary™.

While we believe that our technology, knowledge and experience as well as the scientific resources at our disposal

provide us with significant competitive advantages, we face potential competition from many different sources.

Any product candidates

we successfully identify will compete not only with existing therapies but also new therapies that may become available in the future.

intend to focus on the development of novel and viable psychedelic-inspired drug candidates for mental illnesses and unmet medical needs,

and partner with pharmaceutical and other drug development and biotechnology companies in developing and commercializing psychedelic-inspired

medicines for diverse psychological and neuropsychiatric indications, which will be fundamentally composed of the psychedelic-inspired

drug candidates contained in the Psybrary™.

While we believe that our technology, knowledge and experience as well as the scientific

resources at our disposal provide us with significant competitive advantages, we face potential competition from many different sources.

Any product candidates we successfully identify will compete not only with existing therapies but also new therapies that may become

available in the future

commercial opportunities could be reduced or eliminated if our competitors develop and commercialize medicines that are safer, more effective,

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our Psybrary™ and the intellectual property kept and developed therein, our success depends on our ability to protect our intellectual

property and our ability to achieve and maintain key partnerships aimed at the development, licensing and marketing of Psychedelic Derivatives

without infringing on the proprietary rights of others.

Patent positions within the pharmaceutical field can be highly uncertain and

involve complex legal, scientific and factual questions for which important legal principles remain unresolved.

Patents issued to us

may be challenged, invalidated or circumvented.

property and our ability to achieve and maintain key partnerships aimed at the development, licensing and marketing of psychedelic-inspired

medicines without infringing on the proprietary rights of others.

Patent positions within the pharmaceutical field can be highly uncertain

and involve complex legal, scientific and factual questions for which important legal principles remain unresolved.

Patents issued to

us may be challenged, invalidated or circumvented.

Regulation and Product Approvals

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execution of our strategy is in part contingent upon compliance with regulatory requirements enacted by governmental authorities and

obtaining regulatory approvals for the development and license of its Psychedelic Derivatives.

The psychedelic therapy industry is a

new and emerging industry with ambiguous existing regulations and uncertainty as to future regulations;

we cannot predict the impact

of the ever-evolving compliance regime in respect of this industry.

The impact of compliance regimes, any delays in obtaining, or failure

to obtain regulatory approvals may significantly delay or impact our development of markets, our business, Psychedelic Derivatives, and

licensing initiatives and could have a material adverse effect on our business, financial condition and operating results.

obtaining regulatory approvals for the development and license of our psychedelic-inspired drug candidates.

The psychedelic-inspired

medicine industry is a new and emerging industry with ambiguous existing regulations and uncertainty as to future regulations;

predict the impact of the ever-evolving compliance regime in respect of this industry.

The impact of compliance regimes, any delays in

obtaining, or failure to obtain regulatory approvals may significantly delay or impact our development of markets, our business, psychedelic-inspired

medicines, and licensing initiatives and could have a material adverse effect on our business, financial condition and operating results.

New Drug Approval Process

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of patients at the European Union level.

Since the U.K.

exited the E.U., it no longer falls under these regulations, however, it has

been decided it will follow EMA as it is transitioning to regulations as defined by the Medicines and Healthcare products Regulatory

Agency (MHRA).

The MHRA has temporary arrangements in place to partially align with EU regulations around medical technology including

the sale of CE-marked medical devices until June 2023 and approval of EU-authorized medicines using a mutual recognition procedure until

the end of 2023.

the centralized procedure in the European Union, the maximum time frame for the evaluation of a marketing authorization application by

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in the near future or perhaps at all.

have consolidated our employee base to save capital and focus on development of our leading candidates EB-002 and EB-003.

As of the date

of this report, we employ 7 full-time employees.

We also work with scientific advisors, consultants and service providers, mainly through

academic institutions and contract research organizations.

have consolidated our employee base to save capital and focus on development of our leading candidates EB-003.

As of the date of this

report, we employ five full-time employees and one part-time employee.

We also work with scientific advisors, consultants and service

providers, mainly through academic institutions and contract research organizations.

have never had a work stoppage and none of its employees are covered by collective bargaining agreements or represented by a labor union.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business