What changed in this filing

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Item 1. Business

2023-03-31 compared with 2022-03-31 · 296 added, 353 removed, 684 unchanged (49% of the section changed)

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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 (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.

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

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

The Amalgamation was completed on

September 16, 2021.

MagicMed’s principal executive offices are located at 777 Hornby Street, Suite 600, Vancouver, British Columbia,

V6Z 1S and its telephone number is (508) 627-0485.

are an early-development-stage biosciences company developing next-generation mental health and oncology treatments using our clinical

discovery platform to help leverage psychedelic-derived molecules for the mind and synthetic cannabinoids for the body.

We seek to improve

the lives of patients suffering from cancer, initially by developing palliative and supportive care products for people suffering from

certain side effects of cancer and cancer treatment such as anxiety, depression, pain, and skin damage from radiation treatment.

intend to offer such palliative and supportive care products in the United States, following approval through established regulatory

The Amalgamation was completed on September

MagicMed’s principal executive offices are located at 777 Hornby Street, Suite 600, Vancouver, British Columbia, V6Z

1S and its telephone number is (508) 627-0485.

Available Information

We are required to file Annual

Reports on Form 10-K and Quarterly Reports on Form 10-Q with the Securities and Exchange Commission (the “SEC”) on a regular

basis, and are required to disclose certain material events in Current Reports on Form 8-K.

The SEC maintains an Internet website that

contains reports, proxy and information statements and other information regarding issuers that file electronically with the SEC.

SEC’s Internet website is located at http://www.sec.gov.

We also make available, free of charge, our Annual Report on Form 10-K,

Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and amendments to these reports on our website at https://www.enveric.com/

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

We are a biotechnology company dedicated to the development of novel small-molecule

therapeutics for the treatment of anxiety, depression, and addiction disorders.

We seek to improve the lives of patients suffering from

cancer, initially by developing palliative and supportive care products for people suffering from certain side effects of cancer and cancer

treatment such as pain or skin irritation.

We currently intend to offer such palliative and supportive care products in the United States,

following approval through established regulatory pathways.

Agreement with MagicMed Industries Inc.

On May 24, 2021, the Company

entered into the Amalgamation Agreement with HoldCo, Purchaser, and MagicMed, pursuant to which, among other things, the Company, indirectly

through Purchaser, acquired all of the outstanding securities of MagicMed 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), Amalco will be an indirect wholly-owned

May 24, 2021, the Company entered into the Amalgamation Agreement with HoldCo, Purchaser, and MagicMed, pursuant to which, among other

things, the Company, indirectly through Purchaser, acquired all of the outstanding securities of MagicMed 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), Amalco will be an indirect wholly-owned

subsidiary of the Company.

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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 derivatives (“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.

have created over 500 molecules that are housed in the Psybrary.

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-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 derivatives (“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™.

screen newly synthesized molecules in the Psybrary™ through PsyAI™, a proprietary artificial intelligence (AI) tool.

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to focus on bringing more psychedelics-inspired molecules from discovery to the clinical phase.

are also aiming to advance a pipeline of novel cannabinoid combination therapies for the side effects of cancer treatments, such as chemotherapy

and radiotherapy.

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.

intend to evaluate options to out-license our proprietary technology as it moves along the regulatory pathway.

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 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

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 Food and Drug

Administration (“FDA”) pre-market approval process for new drugs.

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

and Related Private Placement

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

Biosciences, Inc.

(“Akos”), a majority owned subsidiary of the Company by way of dividend to the Company’s shareholders

(the “Spin-Off”).

The Spin-Off will be 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.

The primary assets and

liabilities included as part of the Spin-Off are intangible assets.

May 5, 2022, Akos, the Company and an investor entered into a Securities Purchase Agreement (the “Akos Purchase Agreement”),

pursuant to which Akos agreed to sell up to an aggregate of 5,000 shares of its Series A Convertible Preferred Stock (the “Akos

Series A Preferred Stock”), par value $0.01 per share at a price of $1,000 per share, and warrants (the “Akos Warrants”)

to purchase shares of Akos’ common stock (the “Akos Common Stock”), par value $0.01 per share, for an aggregate purchase

price of up to $5,000,000 (the “Akos Private Placement”).

Pursuant to the Akos Purchase Agreement, Akos issued 1,000 shares

of the Akos Series A Preferred Stock to investors in exchange for $1,000,000 on May 5, 2022.

the Spin-off is successful, the Company would be spinning off the cannabinoid business to Akos and focus solely on psychedelic-based

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

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of two molecular conjugates EV104a and EV104b

First-generation

psychedelic asset:

psilocybin oral formulation

Related Distress (CRD)

cancer research centers in Canada and US member of the National Comprehensive Cancer Network (NCCN)

Currently under evaluation;

Research & Development / Discovery

Phase 1/2 trial

Second-generation

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prodrug of psilocin

Related Distress (CRD)

& Development, Lead Optimization

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experimentation

Cannabinoid Cream for Topical skin Application

Dermatitis (aka radiodermatitis), a radiotherapy-induced skin dermatitis

leading cancer center, member of the National Comprehensive Cancer Network (NCCN)

& Development / IND-enabling studies in planning

Phase 1/2 clinical trial

Cannabinoid + Chemotherapy Combination Therapy

synthetic CBD extract given alone or in combination with clomiphene, concurrently with dose-dense Temolozomide chemotherapy

or progressive

Medical Center, Davidoff Institute of Oncology

Cannabinoid-Infused

Topical Product

Oncology-related

skincare conditions (e.g., radiodermatitis)

Center of Excellence

& Development/Discovery

Phase 1/2 trial

Exploratory Phase 1/2 trial

and COX-2 inhibitor Conjugation

conjugated New Chemical Entity

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

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Of those, 10 patent applications relate to psilocybin derivatives,

methods of making psilocybin derivatives, and methods for treatment of mental disorders, such as cancer-related distress, PTSD, and other

methods of making psilocybin derivatives, and methods for treatment of mental disorders, such as anxiety, PTSD, and other

psychiatric conditions;

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The portfolio includes the following published and unpublished applications:

● Glycosylated

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

Relates to glycosylated psilocybin derivative compounds that activate

the 5-HT2A cell surface receptor and increase intracellular calcium concentration with a profile different from that of psilocin,

methods for making the compounds, and methods for treating psychiatric disorders.

Psilocybin Derivatives and Methods of Using (WO2022047579) Relates to halogenated psilocybin derivative compounds, methods for

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

Psilocybin Derivatives and Methods of Using (WO2022047580) Relates to hydroxylated psilocybin derivative compounds, methods for

making the compounds,, and methods for modulating a 5-HT2A cell surface receptor.

Relates to glycosylated

psilocybin derivative compounds that activate the 5-HT2A cell surface receptor and increase

intracellular calcium concentration with a profile different from that of psilocin, methods

for making the compounds, and methods for treating psychiatric disorders.

● Halogenated

Psilocybin Derivatives and Methods of Using (WO2022047579):

Relates to halogenated psilocybin

derivative compounds, methods for making the compounds, and methods for modulating a 5-HT2A

cell surface receptor, and methods for treating psychiatric disorders.

● Hydroxylated

Psilocybin Derivatives and Methods of Using (WO2022047580):

Relates to hydroxylated psilocybin

derivative compounds, methods for making the compounds,, and methods for modulating a 5-HT2A

cell surface receptor.

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

Relates to nitrated psilocybin

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receptor, and methods for treating psychiatric disorders.

Derivatives and Methods of Using ( Five PCT Applications, unpublished, and 1 US Provisional Applications, all unpublished):

Each relates 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.

Derivatives and Methods of Using (Five PCT Applications, unpublished, and 1 US Provisional

Applications, all unpublished):

Each relates 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.

for Psilocin and Methods of Using (U.S.

Provisional Application, unpublished):

Relates to prodrugs for psilocin, and methods

for making the prodrug compounds.

to prodrugs for psilocin, and methods for making the prodrug compounds.

Derivatives and Methods of Using (Five US Provisional Applications, all unpublished):

Relates to mescaline derivative compounds,

and methods for making the compounds.

Relates to mescaline derivative compounds, and methods for making the compounds.

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

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for treating the side effects of cancer, including radiodermatitis, pain and other conditions, including the following:

Therapy (US Patent No.11.090,275 and national phase patent filings from WO2017072773 pending in the U.S.

and other countries/regions):

Combinations of compositions comprising CBD and therapeutic pharmaceutical cancer agents (ChEH/AEBS inhibitors, naphthoquinone

or derivatives) for the treatment of cancer.

Therapy (EP 18165731.3 and national phase patent filings from WO2019/193112 pending in the U.S.

and other countries/regions):

to regimes of drug administration and drug combinations that include a cannabinoid for use in the treatment of breast cancer, including

triple-negative breast cancer.

in Combination with Chemotherapy (US national phase filing from WO2021/028646):

Relates to regimes of drug administration and

cannabinoid administration for treatment of bladder, brain and spinal cord, colorectal, head and neck, lung, lymphoma, neuroendocrine,

esophageal, ovarian, pancreatic, and prostate cancer.

● Compositions

for Topical Treatment of Radiation Dermatitis:

(US Provisional Applications, unpublished):

Relates to novel compositions of topical

formulations including a novel carrier for treatment of radiodermatitis.

Relates to novel compositions of topical formulations including a novel carrier for treatment

of radiodermatitis.

● Compositions

for Topical Treatment of Radiation Dermatitis:

(US Provisional Applications, unpublished):

Relates to novel compositions of topical

formulations including a complex formula for treatment of radiodermatitis.

Relates to novel compositions of topical formulations including a complex formula for treatment

of radiodermatitis.

● Cannabinoid

Conjugate Molecules:

(Three US Provisional Applications, unpublished):

Relates to conjugate molecules of cannabinoids and novel

forms of cannabinoids linked to celecoxib and other COX-2 inhibitors, and methods for making, for treatment of osteoarthritis.

Relates to conjugate

molecules of cannabinoids and novel forms of cannabinoids linked to celecoxib and other COX-2

inhibitors, and methods for making, for treatment of osteoarthritis.

Supply Agreement

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novel therapies using psychedelic-inspired and cannabinoid-based medications and similar compounds.

Our current research and development

efforts are focused on developing novel molecules structurally related to certain naturally occurring psychedelics with improved pharmaceutical

characteristics.

Some of the naturally occurring psychedelic molecules are currently being investigated by researchers around the world

as potential treatments for a broad range of psychiatric and neurologic disorders.

Additionally, we maintain limited activities dedicated

to investigative work surrounding cannabinoids, including creating and developing novel formulations, and evaluating potential opportunities

to license technologies from pharmaceutical companies and leading research institutions.

Our current research and

development efforts are focused on developing novel molecules structurally related to certain naturally occurring psychedelics with

improved pharmaceutical characteristics.

Some of the naturally occurring psychedelic molecules are currently being investigated by

researchers around the world as potential treatments for a broad range of psychiatric and neurologic disorders.

Additionally, we

maintain activities dedicated to investigative work surrounding cannabinoids which are expected to be spun-out, including creating and developing novel formulations,

and evaluating potential opportunities to license technologies from pharmaceutical companies and leading research

institutions.

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

toward development candidate selection, followed by IND-enabling studies and filing of a US-IND application with the aim of initiating

first-in-human studies.

The primary indication for our psychedelics program addresses a high unmet need in cancer patients who are afflicted

with Cancer Related Distress (CRD).

We intend to assemble a team of principal investigators with clinical experience across multiple

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

plan to submit INDs and, eventually, new drug applications (“NDAs”) to seek FDA approval in connection with the Cancer Related

Distress product candidates.

The selection, timing, duration, and design of any prospective studies are subject to approval and finalization.

towards the clinic.

Enveric’s lead program, EB-373, is a next generation prodrug of psilocin, the active metabolite of psilocybin.

EB-373 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.

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.

On March 23, 2023, we issued a press release announcing the selection of

Australian CRO, Avance Clinical, in preparation for Phase 1 Study of EB-373, our lead candidate targeting the treatment of anxiety disorders.

The Phase 1 clinical trial is expected to initiate in the fourth quarter of 2023.

Under the agreement, Avance Clinical will manage the

Phase 1 clinical trial of EB-373 in coordination with our newly established Australian subsidiary, Enveric Therapeutics Pty, Ltd.

Phase 1 clinical trial is designed as a multi-cohort, dose-ascending study to measure the safety and tolerability of EB-373.

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.

Advisory Board

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Specialization

Zelefsky, M.D.

Chair, Department of Radiation Oncology, Chief, Brachytherapy Service, Memorial Sloan Kettering Cancer Center

Cancer Rehabilitation and Survivorship, Cedars-Sinai Cancer Center

Medicine & Rehab

Dalgleish, M.D.

George’s University of London

Neuro-Oncologist,

Sunnybrook Research Institute;

Professor, University of Toronto

Neurobiology, Weizmann Institute

Research, Patent Contributor

Hack, M.D., M.P.H.

Professor of Neurosurgery at the University of Pittsburg;

Associate Clinical Professor at the Department of Physical Medicine and

Rehabilitation at Virginia Commonwealth University

Zelefsky, M.D.

has served as a Scientific Advisor of Enveric since April 2019.

Zelefsky, is a board-certified radiation oncologist

and co-leader of Memorial Sloan Kettering’s Genitourinary Disease Management Team, a multidisciplinary group of physicians who

work together to treat patients with urologic malignancies.

Zelefsky is Chief of Memorial Sloan Kettering’s Brachytherapy Service.

The prostate brachytherapy program at Memorial Sloan Kettering, which Dr.

Zelefsky helped develop and enhance since joining the staff

in 1990, is known for its depth of experience and cutting-edge approach in treating men with prostate cancer.

Zelefsky was instrumental

in pioneering the use of IMRT (intensity-modulated radiation therapy, which is computer-guided delivery of high doses of radiation directly

to the tumor) and IGRT (image-guided radiotherapy, radiation beams targeted precisely to the tumor) for treating men with prostate cancer.

Zelefsky is Editor-in-Chief of Brachytherapy, a medical journal that addresses all aspects of this sub-specialty, and Chairman of

the National Patterns of Care Study for Genitourinary Cancers.

He is also a past president of the American Brachytherapy Society.

his work in this field, Dr.

Zelefsky has been honored to receive several awards including the Boyer Award for Excellence in Clinical

research, the Outstanding Teaching Award in the Department of Radiation Oncology at Memorial Sloan Kettering, the 2009 Henschke Medal

(the highest award of the American Brachytherapy Society for achievements in Brachytherapy), and the 2009 Emanuel Van Descheuren Award

for Excellence in Translational Research.

has served as a Scientific Advisor of Enveric since May 2021.

Asher is a physiatrist and Director of Cancer Survivorship

and Rehabilitation at Cedars-Sinai Cancer Center in West-Hollywood, CA.

His deep knowledge of chemotherapy-induced peripheral neuropathy

and clinical and research interests with focus on the rehabilitation of cancer patients to help restore their maximal functional capacity

as well as their quality of life are a key component to bringing safe, effective care to cancer patients who continue to suffer from

their treatment side effects.

Asher has led the development of a number of unique cancer survivorship programs focusing on physical

and psychological resilience.

He currently has several active studies reflecting his passion for improving outcomes for cancer patients

and his expertise in pain management, cancer-related fatigue, cognitive dysfunction, neuropathy and the management of musculoskeletal

Asher’s affiliations with Cedars-Sinai also include serving as Associate Professor in the Departments of Medicine

and Physical Medicine and Rehabilitation.

Asher completed a physical medicine and rehabilitation residency at the UCLA / West Los

Angeles Veterans Affairs program, as well as a cancer rehabilitation fellowship at the MD Anderson Cancer Center.

He is board-certified

by the American Board of Physical Medicine and Rehabilitation and Hospice and Palliative Medicine.

Dalgleish, M.D.

has served as a Scientific Advisor of Enveric since January 2019.

Dalgleish, is an oncologist practicing in the

United Kingdom at St.

Director of the Clinical Trials Network and Institute

Stahl, M.D., Ph.D.

of Psychopharmacology forthe California Department of State Hospitals

DeWitt, Ph.D.

Chair, President & CEO of DeuteRx,

COO of Neuromity Therapeutics, Inc.;

Founder of RIFFIT, Inc.;

Professor, St.

George’s University of London

Dalgleish divides his time between clinical practice and research, and

also serves as an advisor to several biopharmaceutical companies.

Dalgleish studied Medicine at University College London, where

he obtained an MBBS and a BSc in Anatomy.

He also trained in Internal Medicine and Oncology in Brisbane and Sydney.

Following an interest

in how viruses caused cancer, he commenced an MD with Professor Robin Weiss, FRS at the Institute of Cancer Research and Royal Marsden

Following five years as a clinical scientist at the MRC’s clinical research center in Northwick Park, he was appointed

to the Foundation Chair in Oncology at St.

George’s University of London in 1991.

There his main interest has been the immunology

of cancer and the development of immunotherapies to treat, in particular, melanoma.

Dalgleish has been a Professor of Medical Oncology

George’s University of London and Consultant Physician at St.

George’s Hospital since 1991.

He has served as the President

of the Clinical Immunology and Allergy Section of the Royal Society of Medicine and is a Fellow of The Royal College of Physicians.

Dalgleish is the author or co-author of peer reviewed scientific papers and over 70 chapters in medical books.

He is the co-editor of

five medical books.

He has been on numerous grant committees and is currently on the European Commission Cancer Board.

has served as a Scientific Advisor of Enveric since April 2019.

James Perry is a neuro-oncologist at Sunnybrook’s

Odette Cancer Centre and Hurvitz Brain Sciences Program.

Perry is also a Professor of medicine at the University of Toronto and the

central nervous system cancers lead at Cancer Care Ontario.

Perry is a clinician-investigator interested in the design, conduct and

analysis of clinical trials testing innovative therapies for primary brain tumors.

His research unit is focused on outcomes research.

He is the chair of the Canadian Brain Tumor Consortium (CBTC), a national not-for-profit investigator network.

He has held leadership

roles in multiple international collaborative clinical trials.

has served as a Scientific Advisor of Enveric since February 2018.

Professor Vogel is currently a Professor Emeritus

at the Weizmann Institute of science serving as the Head of the Adelson Center for the Biology of Addictive Diseases at Tel-Aviv University.

Professor Vogel previously served as the Chairman of the Department of Neurobiology at the Weizmann Institute.

He has published more

than 170 scientific manuscripts.

Professor Vogel earned an M.Sc.

in Biochemistry and a Ph.D.

from the Weizmann Institute of Science.

He performed his post-doctorate studies at the National Institutes of Health (Bethesda, MD) in the Laboratory of Marshall Nirenberg,

a Nobel Prize winner.

Hack, M.D., M.P.H.

has served as a Scientific Advisor of Enveric since November 2021.

Hack is an Adjunct Professor

of Neurosurgery at the University of Pittsburgh, and an Associate Clinical Professor with the Department of Physical Medicine

and Rehabilitation at Virginia Commonwealth University.

Prior to entering active service in 1987, when he accepted a position in clinical

research at the U.S.

Army Medical Research Institute of Infectious Diseases, Dr.

worked both in General Practice as

well as in several functions in the private biomedical industry.

After assignments at Fort Detrick and Fort Knox, he served, amongst

other appointments, as the Command Surgeon for the Central Command-Kuwait from 2001 to 2002 and the Multinational Force Iraq from 2004

From 2008 to 2014 he served as the Director of the Combat Casualty Care Research Program in Ft.

Detrick, MD, coordinating leading

edge research including a portfolio directed at Traumatic Brain Injury.

Hack has received numerous military awards, including the

Bronze Star and two Legions of Merit.

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.

Maurizio Fava is 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.

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 work.

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.

has served as a Scientific Advisor of Enveric since 2022.

Stephen Stahl has held faculty positions at Stanford

University, the University of California at Los Angeles, the Institute of Psychiatry London, the Institute of Neurology London, and,

currently, as Clinical Professor of Psychiatry and Neuroscience at the University of California Riverside, Adjunct Professor of Psychiatry

at the University of California San Diego and as Honorary Fellow in Psychiatry at the University of Cambridge.

Stahl serves as editor-in-chief

of CNS Spectrums and is Senior Academic Advisor and Director of Psychopharmacology for the California Department of State Hospitals (DSH)

where he has a leadership role in addressing violence and decriminalization of the seriously mentally ill.

Author of over 575 articles

and chapters with an H index of 69, and more than 2000 scientific presentations and abstracts, Dr.

Stahl is an internationally renowned

clinician, researcher, and teacher in psychiatry with subspecialty expertise in psychopharmacology.

Stahl has written over 50 textbooks

and edited 15 others, including the best-selling and award-winning textbook, Stahl’s Essential Psychopharmacology, now in its fifth

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.

John Krystal is the Robert L.

McNeil, Jr., Professor

of Translational Research;

Professor of Psychiatry, Neuroscience, and Psychology;

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.

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.

National Academy of Medicine;

of the Neuroscience Forum of the U.S.

National Academies of Sciences, Engineering, and Medicine;

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

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.

and Industry Partners

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current academic and industry partners are set forth in the table below:

brings proprietary products and data, clinical research experience, and access to resources in Israel.

George’s University of London

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University of Calgary

University of Calgary, through its Hotchkiss Brain Institute, brings excellence into advancing brain and mental health research

and education.

University of Calgary, through its Hotchkiss Brain Institute, brings excellence into advancing brain and mental health research and

biotechnology and pharmaceutical industries are characterized by rapidly advancing technologies, intense competition, and a strong emphasis

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

diagnosis of Cancer Related Distress (CRD) has been characterized by neuropsychological (emotional, behavioral and cognitive), social,

spiritual, and physical ailments.

The diagnosis and treatment of cancer are associated with psychological distress which encompasses

serious consequences that interfere with one’s ability to cope effectively and comply with treatment to ensure optimal outcome.

Such distress extends along a continuum, ranging from common normal feelings of vulnerability, sadness, and fear to problems that can

become disabling, such as depression, anxiety, panic, social isolation, and existential and spiritual crisis.

growing awareness and body of literature surrounding CRD came to be defined in recent years;

however, no approved treatment is available

and there remains significant unmet need to treat CRD.

Addressing CRD is among our goals in developing novel and viable Psychedelic

Derivatives for mental illnesses and unmet medical needs includes.

are currently working to advance a pipeline of novel cannabinoid combination therapies for hard-to-treat cancers, including glioblastoma

multiforme (GBM) and several other indications.

For the treatment of

Glioblastoma Multiforme (GBM), we believe that only one drug product (Epidiolex, developed by GW Pharmaceuticals) is a potential late-stage

competitor to our GBM product candidate, EV101:

Cannabinoid + Chemotherapy Combination Therapy.

Other than Epidiolex, we are aware

of exploratory research into the effects of cannabinoid drug formulations.

We are also aware of discovery research within the pharmaceutical

industry into synthetic agonists and antagonists of CB1 and CB2 receptors, as well as companies that supply synthetic cannabinoids and

cannabis extracts to researchers for pre-clinical and clinical investigation, and various companies that cultivate cannabis plants with

a view to supplying herbal cannabis or non-pharmaceutical cannabis-based formulations to patients.

These therapies have not been approved

suffering from GBM in the U.S.

are treated with a variety of FDA-approved products, including, but not limited to, Bevacizumab, Carmustine

Implant, Lomustine, and Temozolomide.

Our potential competitors regarding the GBM product candidate include pharmaceutical and biopharmaceutical

companies such as Pfizer, Genentech, Arbor Pharmaceuticals, Next Source Pharmaceuticals, and Merck, among others, depending on when the

candidate is approved for commercialization, if ever (and what, if any, new therapies are approved in the interim).

Such competitors

may have significantly greater financial resources and expertise in research and development, manufacturing, preclinical testing, conducting

clinical trials, obtaining regulatory approvals, and marketing approved medicines than we do.

These competitors also compete with us

in recruiting and retaining qualified scientific and management personnel and establishing clinical trial sites and patient registration

for clinical trials, as well as in acquiring technologies complementary to, or necessary for, our programs.

radiation dermatitis (also referred to as radiodermatitis) product candidate, EV102:

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and satisfy, such rigorous scrutiny.

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

more effective, have fewer or less severe side effects, are more convenient or are less expensive than any product candidates that we

Our competitors also may obtain approval from the FDA or other regulatory agencies for their medicines more rapidly than

us, which could result in our competitors establishing a strong market position before we are able to enter the market.

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

have fewer or less severe side effects, are more convenient or are less expensive than any product candidates that we may develop.

competitors also may obtain approval from the FDA or other regulatory agencies for their medicines more rapidly than us, which could

result in our competitors establishing a strong market position before we are able to enter the market.

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

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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.

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.

New Drug Approval Process

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requirements may subject a company to a variety of administrative

or judicial sanctions, such as imposition of clinical holds, FDA refusal to approve pending NDAs, warning letters, product recalls,

product seizures, total or partial suspension of production or distribution, injunctions, fines, refusals of government contracts, restitution,

or judicial sanctions, such as imposition of clinical holds, FDA refusal to approve pending NDAs, warning letters, product recalls, product

seizures, total or partial suspension of production or distribution, injunctions, fines, refusals of government contracts, restitution,

disgorgement, civil penalties and criminal prosecution.

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implementing the Animal Welfare Act.

The results of pre-clinical testing are submitted to the FDA as part of an IND application

along with other information, including information about product chemistry, manufacturing and controls, and a proposed clinical trial

Long-term pre-clinical tests, such as animal tests of reproductive toxicity and carcinogenicity, may continue after the IND

application is submitted.

30-day waiting period after the submission of each IND application is required prior to the commencement of clinical testing in

If the FDA has not imposed a clinical hold on the IND application or otherwise commented or questioned the IND application

within this 30-day period, the clinical trial proposed in the IND application may begin.

The results of pre-clinical testing are submitted to the FDA as part of an IND application along

with other information, including information about product chemistry, manufacturing and controls, and a proposed clinical trial protocol.

Long-term pre-clinical tests, such as animal tests of reproductive toxicity and carcinogenicity, may continue after the IND application

is submitted.

30-day waiting period after the submission of each IND application is required prior to the commencement of clinical testing in humans.

If the FDA has not imposed a clinical hold on the IND application or otherwise commented or questioned the IND application within this

30-day period, the clinical trial proposed in the IND application may begin.

trials involve the administration of the IND to healthy volunteers or patients under the supervision of a qualified investigator.

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performance goals call for the FDA to complete review of 90 percent of standard (non-priority) NDAs within 10 months of receipt and within

six months for priority NDAs, but two additional months of review are added to standard and priority NDAs for a new molecular

entity (NME).

six months for priority NDAs, but two additional months of review are added to standard and priority NDAs for a new molecular entity

FDA may also refer applications for novel drug products, or drug products that present difficult questions of safety or efficacy, to

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distribution, importation and other requirements under the oversight of the Drug Enforcement Agency (“DEA”).

is the federal agency responsible for regulating controlled substances, and requires those individuals or entities that manufacture,

import, export, distribute, research, or dispense controlled substances to comply with the regulatory requirements in order to prevent

the diversion of controlled substances to illicit channels of commerce.

DEA categorizes controlled substances into one of five schedules — Schedule I, II, III, IV or V — with

varying qualifications for listing in each schedule.

Schedule I substances by definition have a high potential for abuse, have no currently

accepted medical use in treatment in the U.S., and lack accepted safety for use under medical supervision.

Marijuana is currently a Schedule

I controlled substance, which means that no preclinical or clinical studies of product candidates containing marijuana may be conducted

in the United States without the required DEA registration(s) and related approvals, as applicable.

Pharmaceutical products having a

currently accepted medical use that are otherwise approved for marketing may be listed as Schedule II, III, IV or V substances, with

Schedule II substances presenting the highest potential for abuse and physical or psychological dependence, and Schedule V substances

presenting the lowest relative potential for abuse and dependence.

The DEA is the

federal agency responsible for regulating controlled substances, and requires those individuals or entities that manufacture, import,

export, distribute, research, or dispense controlled substances to comply with the regulatory requirements in order to prevent the diversion

of controlled substances to illicit channels of commerce.

DEA categorizes controlled substances into one of five schedules — Schedule I, II, III, IV or

V — with varying qualifications for listing in each schedule.

Schedule I substances by definition have a high

potential for abuse, have no currently accepted medical use in treatment in the U.S., and lack accepted safety for use under medical

Marijuana and psychedelics such as psilocybin, DMT, mescaline and MDMA are currently Schedule I controlled substances,

which means that no preclinical or clinical studies of product candidates containing these substances may be conducted in the United States

without the required DEA registration(s) and related approvals, as applicable.

Pharmaceutical products having a currently accepted

medical use that are otherwise approved for marketing may be listed as Schedule II, III, IV or V substances, with Schedule II

substances presenting the highest potential for abuse and physical or psychological dependence, and Schedule V substances presenting

the lowest relative potential for abuse and dependence.

that manufacture, distribute, import, or export any controlled substance must register annually with the DEA.

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national marketing authorizations within the European Union.

Fundamentally, the MRP may be applied for all human drugs for which

the centralized procedure is not obligatory.

The MRP is applicable to the majority of conventional medicinal products, and must be used

if the product has already been authorized in one or more European Union member states.

MRP functions by building on an already-existing marketing authorization

in a member state of the European Union which is used as a reference in order to obtain marketing authorizations in other European

Union member states.

Under the MRP, if a marketing authorization for a drug already exists in one or more member states

of the European Union and subsequently marketing authorization applications are made in other European Union member states by referring

to the initial marketing authorization.

The member state in which the marketing authorization was first granted will then act as the

reference member state.

The member states where the marketing authorization is subsequently applied for act as concerned member states.

The concerned member states are required to grant an authorization recognizing the existing authorization in the reference member state,

unless they identify a serious risk to public health.

Fundamentally, the MRP may be applied for all human drugs for which the

centralized procedure is not obligatory.

The MRP is applicable to the majority of conventional medicinal products, and must be used if

the product has already been authorized in one or more European Union member states.

MRP functions by building on an already-existing marketing authorization in a member state of the European Union which is used as a reference

in order to obtain marketing authorizations in other European Union member states.

Under the MRP, if a marketing authorization for a

drug already exists in one or more member states of the European Union and subsequently marketing authorization applications are made

in other European Union member states by referring to the initial marketing authorization.

The member state in which the marketing authorization

was first granted will then act as the reference member state.

The member states where the marketing authorization is subsequently applied

for act as concerned member states.

The concerned member states are required to grant an authorization recognizing the existing authorization

in the reference member state, unless they identify a serious risk to public health.

MRP is based on the principle of the mutual recognition by European Union member states of their respective national marketing authorizations.

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of the agreement.

any European Union member state refuse to recognize the marketing authorization by the reference member state, on the grounds

of potential serious risk to public health, the issue will be referred to a coordination group.

Within a time frame of 60 days, member

states shall, within the coordination group, make all efforts to reach a consensus.

If this fails, the procedure is submitted to an EMA

scientific committee for arbitration.

The opinion of this EMA Committee is then forwarded to the European Commission, for the start of

the decision-making process.

As in the centralized procedure, this process entails consulting various European Commission Directorates

General and the Standing Committee on Human Medicinal Products.

any European Union member state refuse to recognize the marketing authorization by the reference member state, on the grounds of potential

serious risk to public health, the issue will be referred to a coordination group.

Within a time frame of 60 days, member states shall,

within the coordination group, make all efforts to reach a consensus.

If this fails, the procedure is submitted to an EMA scientific

committee for arbitration.

The opinion of this EMA Committee is then forwarded to the European Commission, for the start of the decision-making

As in the centralized procedure, this process entails consulting various European Commission Directorates General and the Standing

Committee on Human Medicinal Products.

the European Union, marketing authorization applications for generic medicinal products do not need to include the results of pre-clinical

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is subject to specific conditions and is not automatically available when data in compliance with the PIP are developed and submitted.

we fail to comply with applicable foreign regulatory requirements, we may be subject to, among other things, fines, suspension

of clinical trials, suspension or withdrawal of regulatory approvals, product recalls, seizure of products, operating restrictions and

criminal prosecution.

we fail to comply with applicable foreign regulatory requirements, we may be subject to, among other things, fines, suspension of clinical

trials, suspension or withdrawal of regulatory approvals, product recalls, seizure of products, operating restrictions and criminal prosecution.

addition, most countries are parties to the Single Convention on Narcotic Drugs 1961, which governs international trade and domestic

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candidates in those countries in the near future or perhaps at all.

We continue to build on our

leadership expertise.

continue to build on our leadership expertise.

We employ 25 full-time employees and 1 part-time employee.

We also work with scientific advisors,

consultants and service providers, mainly through academic institutions and contract research organizations.

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.

We believe that we have good relationships with our employees.

time to time, we may be a party to litigation that arises in the ordinary course of its business.

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 its results of operations,

financial condition or cash flows.

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