What changed in this filing

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Item 1. Business

2022-03-31 compared with 2021-04-01 · 607 added, 622 removed, 430 unchanged (74% of the section changed)

were incorporated under the laws of the State of Delaware in February 1994 as Spatializer Audio Laboratories, Inc., which was a shell

company immediately prior to the completion of a “reverse merger”

transaction on May 26, 2015, whereby Ameri100 Acquisition,

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.

(“Ameri

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

As a result of the 2015 Merger, Ameri and Partners became

Ameri’s wholly owned subsidiary with Ameri and Partners’

former stockholders acquiring a majority of the outstanding shares

of Ameri common stock.

The 2015 Merger was consummated under Delaware law pursuant to an Agreement of Merger and Plan of Reorganization,

dated as of May 26, 2015 (the “2015 Merger Agreement”), and in connection with the 2015 Merger, Ameri changed its name to

AMERI Holdings, Inc.

Ameri did business under the brand name “Ameri100”.

Ameri, along with its eleven operating subsidiaries,

provided SAP cloud, digital and enterprise services to clients worldwide.

Ameri business ceased to be part of the Company on December 30, 2020, pursuant to the Spin-Off.

On December 30, 2020, we completed 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, 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 prospectus.

We have included our website address in this prospectus solely

as a textual reference.

are an early-development-stage biosciences company with an initial focus on developing innovative, evidence-based prescription

products and combination therapies containing cannabinoids to address unmet needs in cancer care.

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.

are also aiming to advance a pipeline of novel cannabinoid combination therapies for hard-to-treat cancers, including glioblastoma multiforme

(GBM) and several other indications which are currently being researched.

intend to bring together leading oncology clinicians, researchers, academic and industry partners so as to develop both external proprietary

and Partners”), 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.

On December 30, 2020, we completed

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 .

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

corporation existing under the laws of the Province of British Columbia and a wholly-owned subsidiary of the Company (“HoldCo”),

Ltd., a corporation existing under the laws of the Province of British Columbia and a wholly-owned subsidiary of HoldCo

(“Purchaser”), and MagicMed Industries Inc., a corporation existing under the laws of the Province of British Columbia (“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), the amalgamated

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

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

subsidiary of the Company.

The Amalgamation was completed on September 16, 2021.

the effective time of the Amalgamation (the “Effective Time”), holders of outstanding common shares of MagicMed (the “MagicMed

Shares”) received such number of shares of common stock of the Company (“Company Shares”) representing, together with

the Company Shares issuable upon exercise of the Warrants and the Converted Options (each as defined herein), approximately 36.6% of

the issued and outstanding Company Shares (on a fully diluted basis).

The MagicMed Shares were initially converted into Amalco Redeemable

Preferred Shares (as defined in the Amalgamation Agreement), which immediately following the Amalgamation were redeemed for 0.000001

of a Company Share.

Following such redemption, the shareholders of MagicMed received additional Company Shares equal to the product of

the Exchange Ratio (as defined in the Amalgamation Agreement) multiplied by the number of MagicMed Shares held by each such shareholder.

Additionally, following the Effective Time (i) each outstanding MagicMed stock option was converted into and became an option to purchase

(the “Converted Options”) the number of Company Shares equal to the Exchange Ratio multiplied by the number of MagicMed Shares

subject to such MagicMed stock option, and (ii) each holder of an outstanding MagicMed warrant (including Company Broker Warrants (as

defined in the Amalgamation Agreement), the “Warrants”) received upon exercise of such Warrant that number of Company Shares

which the holder would have been entitled to receive as a result of the Amalgamation if, immediately prior to the date of the Amalgamation

(the “Effective Date”), such holder had been the registered holder of the number of MagicMed Shares to which such holder

would have been entitled if such holder had exercised such holder’s Warrants immediately prior to the Effective Time (the foregoing

collectively, the “Amalgamation”).

In aggregate, holders of MagicMed Shares received 9,951,217 Company Shares representing

approximately 31.7% of the Company Shares following the consummation of the Amalgamation.

The maximum number of Company Shares to be

issued by the Company as in respect of the Warrants and Converted Options shall not exceed 7,404,101 Company Shares.

aggregate number of Company Shares that the Company issued in connection with the Amalgamation (collectively, the “Share Consideration”)

was in excess of 20% of the Company’s pre-transaction outstanding Company Shares.

Accordingly, the Company sought and received

stockholder approval of the issuance of the Share Consideration in the Amalgamation in accordance with the NASDAQ Listing Rules.

to the terms of the Amalgamation Agreement, the Company appointed, effective as of the Effective Time two individuals selected by MagicMed

to the Company Board of Directors, Dr.

Joseph Tucker and Dr.

Brad Thompson.

Amalgamation Agreement contained representations and warranties, closing deliveries and indemnification provisions customary for a transaction

of this nature.

The closing of the Amalgamation was conditioned upon, among other things, (i) the Share Consideration being approved

for listing on Nasdaq, (ii) the effectiveness of a Registration Statement on Form S-4 registering the Share Consideration (the “S-4

Registration Statement”) and (iii) the approval (a) of the MagicMed stockholders of the Amalgamation and (b) of the Company’s

stockholders of each of the Amalgamation and the issuance of the Share Consideration in the Amalgamation.

The closing of the Amalgamation

occurred on September 16, 2021.

Industries develops and commercializes psychedelic-derived pharmaceutical candidates.

MagicMed’s psychedelic derivatives library,

the Psybrary™, is an essential building block from which industry can develop new patented products.

The initial focus of the Psybrary™

is on psilocybin and DMT derivatives, and it is then expected to be expanded to other psychedelics.

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.

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

AI systems is expected to reduce the time and cost of pre-clinical, clinical, and commercial development.

We believe it streamlines pharmaceutical

design by predicting ideal binding structures of molecules, manufacturing capabilities, and pharmacological effects to help determine

ideal drug candidates, tailored to each indication.

Each of these molecules that we believe are patentable can then be further screened

to see how changes to its makeup alter its effects in order to synthesize additional new molecules.

New compounds of sufficient purity

are undergoing pharmacological screening, including non-clinical (receptors/cell lines), preclinical (animal), and ultimately clinical

(human) evaluations.

We intend to utilize our Psybrary™ and the AI tool to categorize and characterize the Psybrary™ substituents

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

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 its proprietary technology as it moves along the regulatory pathway and evaluates the building

of a small, targeted selling organization and will potentially utilize a hybrid approach based on the product indication and the market

developing our product candidates, we intend to focus on cannabinoids derived from hemp, other botanical sources, and synthetic materials

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.

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therapeutic formulations, THC, which is responsible for the psychoactive properties of marijuana, can result in undesirable mood effects.

Cannabidiol (CBD) and cannabigerol (CBG), on the other hand, are not psychotropic and are therefore more attractive candidates for translation

into therapeutic practice.

In the future, we may utilize cannabinoids that are derived from cannabis plants, which may contain THC;

we only intend to do so in jurisdictions where THC is legal.

These product candidates will then be studied through a typical Food and

Drug Administration (“FDA”) drug approval process.

believe that we offer the following key distinguishing characteristics:

Dedication to Prescription Cancer Supportive Care .

We believe that we are one of the only companies currently developing evidence-based

prescription-only therapies containing cannabinoids that are exclusively focused on the unique unmet needs of cancer patients.

intend to develop such therapies by conforming its product candidates to GMP and obtaining FDA approval for such product candidates.

Patient-Centric

Product Development .

We are focusing on a patient-centric approach to our product development that will uniquely position us

to meet the needs of oncology patients.

Mover Advantage .

We believe we are among the first companies working towards creating a leading brand utilizing cannabinoids

in oncology supportive care.

We seek to build upon our first mover advantage and expertise in cannabinoid research to accelerate

the discovery, development, and commercialization of therapies for persons affected by cancer that are safe, effective, and trusted

by patients and physicians globally.

Collaboration

with Global Research Partner .

We enjoy an exclusive license with our global cannabinoid research partner, Tikun Olam.

exclusive global rights to Tikun Olam’s proprietary treatment database and cannabinoid derivatives for the development of oncology-focused

pharmaceutical products.

We intend to leverage Tikun Olam’s large-scale human datasets and expand upon Tikun Olam’s existing

research by conducting new studies.

Sophisticated

Leadership Team and Scientific Advisors .

We have a world-class leadership team with extensive regulated pharmaceutical industry

backgrounds and deep expertise in oncology, skin and wound care, and clinical research.

In addition, we closely collaborate with

a broad network of leading physicians and scientists at major institutions.

Seeking Growth and Enhancement Opportunities .

We have identified a pathway to business growth and shareholder value creation

based on our planned development programs and eventually plan to leverage the credibility of that expertise into broader offerings.

We will continue to expand our opportunities to add assets that are complementary or accretive to our plans to serve patients through

acquisition and in-licensing.

Market Strategy and Business Approach

have a two-step go-to-market strategy:

Product Candidates :

Develop product candidates that target skincare-related ailments common among cancer patients, such as radiodermatitis,

chemotherapy-induced neuropathy, pruritus, rashes, and dry skin.

Advance novel cannabinoid combination therapies for persons with cancer, starting with programs in glioblastoma multiforme

believe that our existing approach to development, and a future ongoing emphasis on data collection, will differentiate us from our peers

and improve the quality of care we are able to provide.

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

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

Cannabinoid-Infused

Topical Product

related skincare conditions (e.g., radiodermatitis)

Center of Excellence

& Development / Discovery

Exploratory Phase 1/2 trial

+ Chemotherapy Combination Therapy

CBD + Celecoxib Conjugate

Osteoarthritis

& Development, Lead Optimization

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

psychedelic asset:

prodrug of psilocin

Related Distress (CRD)

& Development, Lead Optimization

and in-vivo experimentation

Third-generation

psychedelic-inspired new chemical entity

health indication

& Development, Hit-to-Lead Generation

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

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Phase 1/2 trial

Potential Development Programs

Target Indications

+ Chemotherapy Combination Therapy

in combination with CBD in patients with selected locally advanced or metastatic breast cancer treated with standard adjuvant chemotherapy

Department of Health and Human Services, based on 2013-2015 data, approximately 38% of men and women will be diagnosed with

cancer at some point during their lifetime.

In 2015, there were an estimated 15,112,098 people living with cancer in the U.S.

of new cases of cancer was 439 per 100,000 men and women per year.

widespread demand, the pharmaceutical market lacks products that address the unique supportive care needs of cancer patients.

we believe that research suggests that cannabis, as a palliative treatment for cancer patients, appears to be a well-tolerated option

to help patients cope with malignancy-related symptoms.

For example, researchers from the Soroka Medical Center in Beersheba, Israel

analyzed data gathered at Tikun Olam’s central clinic from cancer patients to whom medical cannabis was given for palliative-care

purposes between March 2015 and February 2017 (Schleiderab, European Journal of Internal Medicine, 2018).

The primary symptoms prior

to treatment reported among the patients to whom medical cannabis was given during the relevant timeframe were sleep problems (78.4%),

pain (77.7%), weakness (72.7%), nausea (64.6%), and lack of appetite (48.9%).

Approximately 51% of the applicable patients reported an

8 out of 10 on the pain scale.

Of the relevant patient population, 17% were given Tikun Olam’s cannabidiol-dominant strain “Avidekel,”

and after six months, 95.9% of patients reported improvement in their condition.

Note, however, that these are anecdotal reports, which

may or may not be indicative of the results that we may see from clinical studies conducted pursuant to an IND.

to a separate survey of 237 oncologists, 80% of these oncologists discussed medical cannabinoids with patients where nearly half recommended

them clinically (Braun IM, J Clin Oncol, 2018).

The same survey found that 67% of the oncologists viewed cannabinoids as a helpful adjunct

to standard pain management strategies, and 65% viewed cannabinoids as equally or more effective than standard treatments for anorexia

and cachexia.

also shows that most cancer patients have a strong interest in learning about cannabinoids during treatment.

According to the Washington

State Survey of Cancer Patients, 74% of surveyed patients wanted information from cancer care providers (Pergam SA, Cancer, 2017).

same survey found that 66% of patients had used cannabis in the past, 24% used in the last year, and 21% used in the last month.

cancer patients tend to be heavy cannabis users.

A survey of active cannabis users who have cancer (Pergam SA, Cancer, 2017) found that

74% used cannabis at least once a week, 56% used cannabis at least daily, and 31% used cannabis multiple times a day.

Active users consumed

cannabis primarily for physical symptoms such as pain and nausea or for psychological reasons such as coping with stress, depression,

and sleep difficulty.

a 2017 report, the National Academy of Sciences noted that, although cannabis has both therapeutic value and public health risks, there

is a systemic lack of research aimed at properly evaluating cannabis-based therapies.

The National Academy of Sciences offered recommendations

that included developing standards and benchmarks to guide cannabis research, addressing research gaps to evaluate the short- and long-term

health effects of cannabis use, improving surveillance capacity to ensure that sufficient data is available, and addressing regulatory

barriers to cannabis research and proposing strategies for supporting a comprehensive cannabis research agenda.

only 30% of oncologists felt sufficiently informed to make recommendations regarding medical cannabis, suggesting a large unmet opportunity

to educate oncologists and provide research that supports the safety and efficacy of Enveric product candidates.

Among the oncologists

who discussed medical cannabis with patients, 78% said that patients were the ones to express interest on most occasions.

for Premium Pricing

plan to conduct extensive clinical research in an effort to establish the safety of its prospective product candidates in cancer patients,

and, eventually, help to identify and/or develop cannabinoid medicines intended to reduce various unwanted side effects that commonly

affect cancer patients, target specific patient sequelae ( e.g.

, cancer pain, anxiety, or nausea), and target specific side effects

to the skin as a result of radiation and chemotherapy treatments.

believe that prescription only medicines containing cannabinoids (including product with hemp-based ingredients) will carry a price premium.

Upon obtaining FDA approval for our product candidates, we are striving to distinguish ourselves from a rising tide of cannabis industry

participants by:

product candidates specific to the side effects of cancer and cancer treatment, with a novel focus on skincare.

evidence-based best practices specific to cancer patients.

clinical research to support the safety and effectiveness of its product candidates in cancer patients.

FDA approval, as most over-the-counter (“OTC”) products sold are not FDA approved.

believe these will be an important differentiator for people with cancer and oncologists who are faced with high patient demand and in

still relatively novel, unproven field of medical cannabis.

Accordingly, we anticipate eventually being able to charge a premium for

those of our prospective product candidates that are successfully commercialized.

Further, more than one-third of cancer patients who

used medical cannabis were new users (K.

Martell, Curr Oncol, 2018), suggesting the potential to establish strong brand loyalty from

cancer patients and oncologists.

Currently Targeted by Enveric

Radiodermatitis

and Other Skin Conditions

therapy is considered an essential component of cancer treatment, with nearly 50% of cancer patients undergoing radiation therapy at

some point during the course of their treatments.

Radiodermatitis, or radiation-induced skin injury, is one of the most common adverse

effects of radiation therapy.

Of those receiving radiation therapy, approximately 90% experience some form of radiodermatitis.

skin is another common adverse side effect of certain cancer therapies.

For example, a recent study of patients being treated with chemotherapy

for breast cancer found that 57.9% of the patients reported dry skin.

Rashes are the most common side effect from targeted cancer therapies

with some treatments.

The incidence of rash varies based on the type of cancer and drug used.

For instance, skin rash occurs in up to

90% of patients treated with Erbitux, while other drugs may only affect half of patients.

Pruritus (itchy skin) is a common adverse side

effect of cancer therapies;

a recent survey of 379 cancer survivors reported that 36% experienced pruritus during treatment.

address the unique skincare needs of persons with cancer, we are seeking to formulate a cannabinoid-based ointment or other topical drug

product for skincare conditions, such as radiodermatitis (among other conditions, as applicable).

Standard of Care

current standard of care for radiodermatitis consists of a combination of preventative routines and symptomatic management based on dermatitis

Preventative skin care routines generally involve keeping the area clean and dry while avoiding skin irritants and unnecessary

friction or skin stress (Salvo, Curr Onvol, 2010;

Wong, Supp Care Canc, 2013).

Applying lanolin-free moisturizer 2-3 times a day throughout

the duration of treatment is also recommended, with some evidence suggesting that topical corticosteroids used after radiotherapy sessions

may provide some benefit as well (Salvo, Curr Onvol, 2010;

Wong, Supp Care Canc, 2013).

the use of these interventions, up to 85% of individuals will experience a moderate to severe skin reaction during their disease course

(Salvo, Curr Oncol, 2010).

This highlights the need for better preventative strategies to reduce the incidence and severity of skin toxicity.

The incomplete success of therapies to date likely relates to the multiple toxic mechanisms of radiation, including direct DNA toxicity,

oxidative stress, and both acute and chronic inflammatory reactions.

Therapies that can address multiple aspects of radiation toxicity

on the cellular level are likely to have the most success as prophylaxis and treatment for these patients.

Current Development Plans

intend to develop products that address unmet medical needs in palliative and supportive care for cancer patients.

The first product

will address radiodermatitis and will enter into clinical trials after an IND submission has been filed.

We then intend to seek FDA approval

via the new-drug-application (NDA 505(b)(1)) pathway.

Multiforme (GBM)

multiforme (GBM) is a highly aggressive and almost universally fatal disease.

Even with the most extensive surgical resections and the

most aggressive radiation and chemotherapy regimens, median overall survival is as low as 15- to 19-months (Stupp, NEJM, 2005).

is likely due, in part, to an intrinsic propensity for treatment resistance and, as a result, the essentially unavoidable event of tumor

The current prognosis for most patients necessitates significant advances in the standard of care to improve both overall

survival and patient quality of life.

believe that CBD has the potential to influence many of the key pathways involved in GBM pathogenesis, from tumor stemness and proliferation

to angiogenesis and local invasion.

GBM tumors express CB2 receptors, through which CBD and other cannabinoids are thought to exert their

anti-cancer efforts (Ellert-Miklaszewska, Adv Exp Med Biol, 2013).

The prospect of CBD used in combination with other pharmacologic interventions

holds promise for the treatment of GBM.

The development of clinical trials to evaluate the efficacy of CBD combination therapies may

represent an important step towards improving the clinical outcomes in a population of patients with few other effective therapeutic

to a study by Kenyon in 2018, seven out of seven patients with GBM experienced a positive clinical response, although four ultimately

succumbed to the disease.

CBD was hypothesized to be able to reduce the growth and survival of GBM cell lines by disrupting the normal

function of the cell, or cell cycle arrest, and the induction of programmed cell death, or apoptosis (Marcu, Mol Cancer Ther, 2010).

Cannabinoids have been shown to promote cancer cell death through the overproduction of a lipid subset, called ceramides, as accumulation

of ceramides in GBM cells may prevent the cell from functioning normally.

Additionally, the generation of unstable oxygen molecules,

or reactive oxygen species, can damage nearby molecules and trigger cell death (Dumitru, Front Mol Neurosci, 2018).

Enveric’s

Prospective Product Candidates

plan to evaluate a novel combination of CBD and an existing chemotherapeutic agent for treating GBM.

We intend to use, as part of the

study, a patent pending formulation developed by a partnership of three Israeli universities led by the Weizmann Institute, and now owned

proposed clinical cancer study plan consists of a Phase 1/2 study in Israel of oral synthetic CBD extract, given alone or in combination

with clomiphene concurrently with dose-dense temolozomide chemotherapy for patients with recurrent or progressive GBM, designed as an

open label, two-arm, randomized prospective study.

An initial dose limiting toxicity (DLT) cohort will be investigated in a phase 1 study

in order to rule out any toxicity related to the combination.

If successful, recruitment would continue, and then 40 patients would be

randomized into two arms, with 20 patients in each arm:

(i) synthetic CBD extract plus clomiphene and temolozomide, and (ii) synthetic

CBD extract plus temolozomide.

The primary endpoints would be progression free survival.

The progression of the disease would be determined

from a Response Assessment in Neuro-Oncology (RANO) and a tumor assessment based on MRI scans.

Safety parameters would include serious

adverse events and other adverse events as reported by the patients and caregivers.

of the date of annual report, all pre-clinical studies, and the draft clinical study protocol related to our clinical cancer program,

have been completed.

Tali Siegal has been selected as the primary investigator, and the protocol is currently under review by the

hospital’s internal review board (IRB).

The Israeli Ministry of Health, Center for Cannabis (Yakar) has given preliminary approval,

and Enveric is currently awaiting its primary approval.

intend to conduct a clinical study to validate the efficacy of topical cream or oral medication infused with high-potency CBD and/or

CBG to help prevent and treat the painful discomfort of chemotherapy-induced neuropathy.

Potential Development Projects

Care Product Candidates

the future, we may also develop additional prescription medicines that are derived from natural sources that are targeted to major cancer

treatment side effects, including other skin conditions, cancer-related distress, chemotherapy-induced nausea and vomiting (CINV), lack

of appetite, pain, and insomnia.

many patients, the concept of palliative care often carries a negative connotation, conjuring ideas and fears of the end of life.

the purpose of palliative care is to improve the patient experience and reduce suffering in all areas of life, including physical, emotional,

psychological, and spiritual well-being.

In fact, incorporating palliative care into cancer management has the potential to not only

improve quality of life, but may also prolong survival (Temei, NEJM, 2010;

Ferrell, J Clin Oncol, 2017).

We avoid the negative connotations

of palliative care by using the term “supportive care”.

physical ailments experienced by cancer patients vary widely based on the individual, the type and stage of cancer, and the choice of

Three of the most common and perhaps most debilitating complaints addressed by palliative care are chronic pain, chemotherapy-induced

nausea and vomiting, and severe body wasting (Reeve, JNCI, 2014).

Although efforts have been made to ameliorate these symptoms, many

patients do not achieve adequate relief.

The need for new therapeutics to improve these debilitating symptoms has gained increasing attention

in recent years.

seek to advance novel treatment for cancer based on a combination of cannabidiol (CBD) and chemotherapeutic agents, including clomiphene,

an anti-estrogen binding site (AEBS) inhibitor, which can regulate cell growth, with a potential for activity in multiple cancer cell

lines, including breast cancer, pancreatic cancer, and acute myeloid leukemia.

data suggests that combination therapies may improve the activity of certain chemotherapies or dendritic cell-based cancer immunotherapies,

potentially enabling more potent or longer-lasting therapeutic effects.

In multiple in vitro and in vivo models of solid

tumors and blood cancers, CBD has been shown to reduce tumor size, potential for invasion and metastasis, and development of new tumor-associated

blood vessels.

In combination with CBD, clomiphene has been shown to reduce cell viability and increase rates of programmed cell death

in certain cancer cell lines, while also inhibiting tumor growth in vivo .

cancer cells contain largely the same proteins and other targets as the healthy cells in the body, there are few cancer-specific druggable

chemotherapies often simply target all rapidly proliferating cells in the body.

While chemotherapy can be successful in suppressing

tumors, there are many side effects associated with use;

side effects may increase with higher doses.

The ability to provide the same

or greater therapeutic effect with a smaller overall dose of the chemotherapeutic agent may minimize the risk and severity of side effects

in subjects and allow for the treatment of certain patients with weakened immune systems.

Combination with AEBS Inhibitors

use of cannabis in cancer management has traditionally been relegated to symptomatic management, including as an analgesic, anti-emetic,

and appetite stimulant.

However, more recently, mounting evidence has suggested a therapeutic, anti-tumor effect of certain naturally

occurring cannabinoids.

Specifically, CBD has been shown to reduce tumor size, the potential for invasion and metastasis, and development

of new tumor-associated blood vessels in multiple in vitro and in vivo models of solid tumors and blood cancers (Ladin, Front Pharmacol,

Massi, Br J Pharmacol, 2013).

is also evidence to suggest that CBD used in combination with traditional chemotherapies and a certain class of compounds, the cholesterol

epoxide hydrolase (ChEH) / antiestrogen binding site (AEBS) inhibitors, may be more efficacious than CBD alone (Scott, Int J Oncol, 2017).

AEBS regulates cholesterol metabolism and, consequently, cell growth (Payre, Mol Cancer Ther, 2008).

AEBS inhibitors that we believe may be especially promising are clomiphene citrate and DPPE.

Clomiphene is an estrogen modulator typically

used to treat infertility.

However, in combination with CBD, clomiphene was recently shown to synergistically reduce cell viability and

increase rates of programmed cell death in certain cancer cell lines, while also inhibiting tumor growth in vivo (WO2017072773A1).

DPPE, on the other hand, is a tamoxifen derivative that is thought to sensitize cancer cells to the activities of chemotherapies.

a tumor grows and mutates, cancer cells can become resistant to therapies in several ways –

tumors can overexpress efflux pumps

that remove certain agents from the cell or can upregulate enzymes that metabolize and inactivate chemotherapies.

DPPE was shown to potentiate

the toxicity of multiple chemotherapeutic drugs by both mechanisms (Georges, Biochemical Pharm, 2014;

Brandes, Cancer Chemother Pharmacol,

Combination with Immunotherapies

cells (DCs) process antigen material and present it on the cell surface to the T-cells of the immune system.

A range of cancer immunotherapies

involving DCs have been used to generate tumor-specific immune responses that have had variable success in clinical trials.

may cause DCs to increase their production of IL-12 p70, an interleukin-12 (IL-12) family cytokine that may heighten the immune system’s

response against certain cancers.

IL-12 is closely linked to the activity of the immune system and is produced by DCs.

IL-12 can bring

T-cells and natural killer cells out of dormancy so that a heightened immune response against tumors is possible.

By aiding in the generation

of CD4+ (T helper cells), IL-12 also can also elicit a longer lasting and amplified anti-tumor response.

IL-12 has presented challenges in terms of its toxicity and dosage control and there is a need for generating heightened levels of IL-12,

particularly in immunocompromised patients.

Preclinical research suggests that CBD may induce DCs to increase their production of IL-12

are a party to certain license agreements as described below, and going forward it intends 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.

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.

own full rights to 16 patent applications related to psychedelics.

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

psychiatric conditions;

1 patent application relates to prodrugs of psilocin;

and 5 patent applications related to mescaline derivatives

and methods of using mescaline derivatives.

The portfolio includes the following published and unpublished applications:

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.

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

Relates to nitrated psilocybin

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.

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

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

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.

Olam In-License

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Olam employs evidence-based medicine and other best practices, and its products have been studied in numerous medical trials.

Tikun Olam’s

patient databases include 12,000+ persons treated across a variety of conditions, with a primary focus on cancer care.

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for the use of cannabinoids with five existing, standard-of-care

drugs via Diverse Biotech’s patent pending conjugate drug delivery platform.

Our rights extend to all fields of use.

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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.

Patents and Patent Applications

own full rights to several families of patent applications covering the use of CBD in combination with current cancer treatments, both

broadly, as well as for specific cancer types, including the following:

Therapy (WO2017072773 and national phase filings in the U.S.

broadly, as well as for specific cancer types;

a portfolio of patent applications directed to formulations including CBD and cannabinoids

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 a therapeutic pharmaceutical cancer agents (ChEH/AEBS inhibitors, naphthoquinone or derivatives) for the treatment of cancer.

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

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):

Relates 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 (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, oesophageal, ovarian, pancreatic

and prostate cancer.

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.

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.

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.

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.

Supply Agreement

February 22, 2021, we entered into an exclusive supply agreement (the “Development and Clinical Supply Agreement”)

with PureForm Global, Inc.

(“PureForm”), a biotechnology company focused on the research, development and commercialization

of synthesized CBD and other cannabinoids not derived from hemp or cannabis, for use in development and commercialization of products

for cancer supportive/palliative care associated with radiodermatitis, chemotherapy induced peripheral neuropathy, and glioblastoma.

Pursuant to the Development and Clinical Supply Agreement, PureForm will be the exclusive provider of synthetic cannabidiol (“API”)

for Enveric’s development plans for cancer treatment and supportive care.

Under the terms of the Development and Clinical

Supply Agreement, PureForm has granted Enveric the exclusive right to purchase API and related products for cancer treatment

and supporting care.

February 22, 2021, we entered into an exclusive supply agreement (the “Development and Clinical Supply Agreement”) with PureForm

(“PureForm”), a biotechnology company focused on the research, development, and commercialization of synthesized

CBD and other cannabinoids not derived from hemp or cannabis, for use in development and commercialization of products for cancer supportive/palliative

care associated with radiodermatitis, chemotherapy induced peripheral neuropathy, and glioblastoma.

Pursuant to the Development and Clinical

Supply Agreement, PureForm will be the exclusive provider of synthetic Cannabidiol (“Synthetic Cannabidiol”) for Enveric’s

development plans for cancer treatment and supportive care.

Under the terms of the Development and Clinical Supply Agreement, PureForm

has granted Enveric the exclusive right to purchase Synthetic Cannabidiol and related products for cancer treatment and supporting care.

& Development

view of the urgent need for new and more effective oncology drugs, we intend to combine innovative science and accelerated clinical development

to create and develop novel therapies using cannabinoid-based medications and similar compounds.

Our past research and development efforts

were limited 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 principal research efforts

to date have been with Soroka Medical Center, MSKCC, Tikun Olam and St.

George’s University of London.

are currently assembling a team of principal investigators with of clinical experience across multiple cancer types to be responsible

for the management, monitoring, and integrity of the clinical research.

The following studies are being evaluated for potential advancement:

Radiodermatitis:

A Phase 1/2 evaluating a CBD-infused formulation for skin.

or Progressive Glioblastoma Multiforme:

A Phase 1/2 study of oral CBD extract in combination with Clomiphene or oral CBD extract

alone given concurrently with dose-dense Temolozomide to patients with recurrent or progressive glioblastoma.

plan to submit INDs and, eventually, NDAs to seek FDA approval in connection with the Radiodermatitis and Recurrent or Progressive Glioblastoma

Multiforme product candidates.

view of the urgent need for new and more effective mental health and palliative oncology treatments, we intend to combine innovative

scientific discoveries and bio-chemical synthesis, along with accelerated clinical development plans to create, develop and progress

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.

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.

Advisory Board

have established a scientific advisory board and regularly seeks advice and input from these experienced clinical leaders on matters

related to its research and development programs.

The members of our scientific advisory board consist of experts across a range of key

disciplines relevant to its programs.

We intend to continue to leverage the broad expertise of its advisors by seeking their counsel

on important topics relating to its product development and clinical development programs.

scientific advisors are not our employees and have commitments to, or consulting or advisory contracts with, other entities that may

have established a scientific advisory board and plan to seek advice and input from these experienced clinical leaders on matters related

to our research and development programs.

The members of our scientific advisory board consist of experts across a range of key disciplines

relevant to our programs.

We intend to continue to leverage the broad expertise of our advisors by seeking their counsel on important

topics relating to our product development and clinical development programs.

scientific advisors are not our employees and do have commitments to, or consulting or advisory contracts with, other entities that may

limit their availability to us.

In addition, its scientific advisors may have arrangements with other companies to assist those companies

In addition, our scientific advisors may have arrangements with other companies to assist those companies

in developing products or technologies that may compete with us.

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devote a limited portion of their time to us.

Enveric’s

current scientific advisors are set forth in the table below:

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

Dagleish, M.D.

George’s University of London

Cancer Rehabilitation and Survivorship, Cedars-Sinai Cancer Center

Medicine & Rehab

Dalgleish, M.D.

George’s University of London

Neuro-Oncologist,

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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.

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

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.

is also a past president of the American Brachytherapy Society.

For 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.

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.

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 has been a Professor of Medical

Oncology at St.

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

George’s Hospital since 1991.

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 studied Medicine at University College London, where he obtained an MBBS and a BSc

Dalgleish, is an oncologist practicing in the

United Kingdom at 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 tumours.

His research unit is focused on

outcomes research.

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

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

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.

has published more than 170 scientific manuscripts.

Professor Vogel earned a 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.

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.

and Industry Partners

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

George’s University of London

George’s University of London brings research capabilities and relevant domain expertise in cancer and cannabinoids.

George’s University of London

George’s University of London brings research capabilities and relevant domain expertise in cancer and cannabinoids.

Soroka Medical Cancer Center

Soroka Medical Cancer Center brings clinical research capabilities and extensive patient access.

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

emphasis on proprietary products.

While we believe that our scientific knowledge and technology and development experience

provide us with competitive advantages, we face potential competition from many different sources, including major pharmaceutical,

specialty pharmaceutical and biotechnology companies, academic institutions, governmental agencies, and public and private research

institutions.

Any product candidates that we successfully develop and commercialize will compete with existing therapies and

new therapies that may become available in the future.

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

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 nonpharmaceutical cannabis-based

formulations to patients.

These therapies have not been approved by the FDA.

In addition, Lutris Pharma has a topical B-Raf

Inhibitor in Phase ½

studies that is intended to treat radiation dermatitis, which is also a potential competitor.

University of Calgary

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

and education.

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

on proprietary products.

While we believe that our scientific knowledge and technology and development experience provide us with competitive

advantages, we face potential competition from many different sources, including major pharmaceutical, specialty pharmaceutical and biotechnology

companies, academic institutions, governmental agencies, and public and private research institutions.

Any product candidates that we

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.

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.

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

respect to CBD, a number of nonapproved and non-standardized CBD preparations derived from crude herbal cannabis have been made

available in limited quantities by producers of “medical marijuana”

We do not believe prescription cannabinoids

are the same as distributing or legalizing crude herbal cannabis, or preparations derived from crude herbal cannabis, and therefore

we do not believe they are competitive with, crude herbal cannabis.

We believe that only a cannabinoid medication, one that is

standardized in composition, formulation and dose, administered by means of an appropriate delivery system, and tested in properly

controlled pre-clinical and clinical studies, can meet the standards of regulatory authorities around the world, including those

We also believe that these regulatory processes provide important protections for patients, and that any cannabinoid

medication must be subjected to, and satisfy, such rigorous scrutiny.

commercial opportunities could be reduced or eliminated if its 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.

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

Cannabinoid Cream for Topical skin Application,

faces competition from Lutric Pharma, which has a topical B-Raf Inhibitor in Phase 1/2 studies that is intended to treat radiation dermatitis.

respect to CBD, a number of non-approved and non-standardized CBD preparations derived from crude herbal cannabis have been made available

in limited quantities by producers of “medical marijuana” in the U.S.

We do not believe prescription cannabinoids are the

same as distributing or legalizing crude herbal cannabis, or preparations derived from crude herbal cannabis, and therefore we do not

believe they are competitive with, crude herbal cannabis.

We believe that only a cannabinoid medication, one that is standardized in

composition, formulation and dose, administered by means of an appropriate delivery system, and tested in properly controlled pre-clinical

and clinical studies, can meet the standards of regulatory authorities around the world, including those of the FDA.

We also believe

that these regulatory processes provide important protections for patients, and that any cannabinoid medication must be subjected to,

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.

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.

Regulation and Product Approvals

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The FDA also has the authority to revoke or withhold approvals of new drug applications.

approval is required before any “new drug,”

can be marketed.

approval is required before any “new drug,” can be marketed.

Our products are new drugs and require prior FDA approval.

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In addition to providing required safety and effectiveness data for FDA approval, a

drug manufacturer’s practices and procedures must comply with current Good Manufacturing Practices (“cGMPs”), which

apply to manufacturing, receiving, holding and shipping, and include, among other things, demonstration of product purity, consistent

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We are subject to periodic inspection by the FDA and the Drug

Enforcement Administration (“DEA”), which inspections may or may not be announced in advance.

intellectual property kept and developed in our Psybrary™ is focused solely on developing and commercializing non-hallucinogenic

synthetic derivatives of psychedelic substances.

While we use psychedelic inspired compounds and classic psychedelics as our starting

point for our research and identification of compounds, we do not have any direct or indirect involvement in the illegal selling, production

or distribution of any substances in the jurisdictions in which we operate.

Enveric is a neuro-pharmaceutical scientific company and

as such we do not advocate for the legalization of psychedelic substances nor do we deal with psychedelic substances except within laboratory

and clinical trial settings conducted within approved regulatory frameworks.

Our products will not be commercialized prior to applicable

regulatory approval and this approval will only be granted if clinical evidence of safety and efficacy for the specific intended use

is successfully developed.

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.

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 new drug applications (“NDA”),

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.

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.

Pharmaceutical

product development in the U.S.

typically involves pre-clinical laboratory and animal tests and the submission to the FDA of an Investigational

New Drug applications (“IND”), which must become effective before clinical testing may commence.

For commercial approval,

the sponsor must submit adequate tests by all methods reasonably applicable to show that the drug is safe for use under the conditions

prescribed, recommended or suggested in the proposed labeling.

The sponsor must also submit substantial evidence, generally consisting

of adequate, well-controlled clinical trials to establish that the drug will have the effect it purports or is represented to have under

the conditions of use prescribed, recommended or suggested in the proposed labeling.

In certain cases, the FDA may determine that a drug

is effective based on one clinical study plus confirmatory evidence.

Satisfaction of FDA pre-market approval requirements typically takes

many years and the actual time required may vary substantially based upon the type, complexity and novelty of the product or disease.

typically involves pre-clinical laboratory and animal tests and the submission to the FDA of an IND,

which must become effective before clinical testing may commence.

For commercial approval, the sponsor must submit adequate tests by

all methods reasonably applicable to show that the drug is safe for use under the conditions prescribed, recommended or suggested in

the proposed labeling.

The sponsor must also submit substantial evidence, generally consisting of adequate, well-controlled clinical

trials to establish that the drug will have the effect it purports or is represented to have under the conditions of use prescribed,

recommended or suggested in the proposed labeling.

In certain cases, the FDA may determine that a drug is effective based on one clinical

study plus confirmatory evidence.

Satisfaction of FDA pre-market approval requirements typically takes many years and the actual time

required may vary substantially based upon the type, complexity and novelty of the product or disease.

tests include laboratory evaluation of product chemistry, formulation and toxicity, as well as animal trials to assess the characteristics

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The conduct of the pre-clinical tests must comply with federal regulations and requirements,

including the FDA’s good laboratory practices regulations and the U.S.

Department of Agriculture’s (USDA’s) regulations

including the FDA’s good laboratory practices regulations and the U.S.

Department of Agriculture’s (USDA’s) regulations

implementing the Animal Welfare Act.

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

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

pre-clinical tests, such as animal tests of reproductive toxicity and carcinogenicity, may continue after the IND is submitted.

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

has not imposed a clinical hold on the IND or otherwise commented or questioned the IND within this 30-day period, the clinical trial

proposed in the IND may begin.

trials involve the administration of the investigational new drug to healthy volunteers or patients under the supervision of a qualified

investigator.

Clinical trials must be conducted:

(i) in compliance with federal regulations, (ii) in compliance with GCP, an international

standard meant to protect the rights and health of patients and to define the roles of clinical trial sponsors, administrators and monitors,

and (iii) under protocols detailing the objectives of the trial, the parameters to be used in monitoring safety and the effectiveness

criteria to be evaluated.

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.

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

trials must be conducted:

(i) in compliance with federal regulations, (ii) in compliance with GCP (“Good Clinical Practice”),

an international standard meant to protect the rights and health of patients and to define the roles of clinical trial sponsors, administrators

and monitors, and (iii) under protocols detailing the objectives of the trial, the parameters to be used in monitoring safety and the

effectiveness criteria to be evaluated.

Each protocol involving testing on U.S.

patients and subsequent protocol amendments must be submitted to the

FDA as part of the IND.

patients and subsequent protocol amendments must be submitted

to the FDA as part of the IND application.

FDA may order the temporary, or permanent, discontinuation of a clinical trial at any time or impose other sanctions if it believes that

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An IRB may also require the clinical trial at the site to be halted, either temporarily or permanently,

for failure to comply with the IRB’s requirements or may impose other conditions.

trials to support NDAs for marketing approval are typically conducted in three sequential phases, but the phases may overlap.

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and optimum dosage, and to identify common adverse effects and safety risks.

If a compound demonstrates evidence of effectiveness and

an acceptable safety profile in Phase 2 evaluations, Phase 3 trials are undertaken to obtain the additional information about clinical

efficacy and safety in a larger number of patients, typically at geographically dispersed clinical trial sites, to permit the FDA to

evaluate the overall benefit-risk relationship of the drug and to provide adequate information for the labeling of the drug.

cases, the FDA requires two adequate and well-controlled Phase 3 clinical trials to demonstrate the efficacy of the drug.

however, determine that a drug is effective based on one clinical study plus confirmatory evidence.

Only a small percentage of investigational

drugs complete all three phases and obtain marketing approval.

In some cases, the FDA may require post-market studies, known as Phase

4 studies, to be conducted as a condition of approval in order to gather additional information on the drug’s effect in various

populations and any side effects associated with long-term use.

Depending on the risks posed by the drugs, other post-market requirements

may be imposed.

a compound demonstrates evidence of effectiveness and an acceptable safety profile in Phase 2 evaluations, Phase 3 trials are undertaken

to obtain the additional information about clinical efficacy and safety in a larger number of patients, typically at geographically dispersed

clinical trial sites, to permit the FDA to evaluate the overall benefit-risk relationship of the drug and to provide adequate information

for the labeling of the drug.

In most cases, the FDA requires two adequate and well-controlled Phase 3 clinical trials to demonstrate

the efficacy of the drug.

The FDA may, however, determine that a drug is effective based on one clinical study plus confirmatory evidence.

Only a small percentage of investigational drugs complete all three phases and obtain marketing approval.

In some cases, the FDA may

require post-market studies, known as Phase 4 studies, to be conducted as a condition of approval in order to gather additional information

on the drug’s effect in various populations and any side effects associated with long-term use.

Depending on the risks posed by

the drugs, other post-market requirements may be imposed.

completion of the required clinical testing, an NDA is prepared and submitted to the FDA.

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The NDA must include the results of all pre-clinical, clinical, and other testing and

a compilation of data relating to the product’s pharmacology, chemistry, manufacture, and controls.

The cost of preparing and submitting

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Under federal law, the submission of most NDAs is additionally subject to a substantial application user fee.

FDA has 60 days from its receipt of an NDA to determine whether the application will be accepted for filing based on the agency’s

threshold determination that it is sufficiently complete to permit substantive review.

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pursuant to the Prescription Drug User Fee Act have effectively extended the initial review cycle beyond 180 days.

The FDA’s current

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 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 (NME).

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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in order for the FDA to reconsider the application.

If, or when, those deficiencies have been addressed to the FDA’s satisfaction

in a resubmission of the NDA, the FDA will issue an approval letter.

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Moreover, product approval may require substantial post-approval testing and

surveillance to monitor the drug’s safety or efficacy.

Once granted, product approvals may be withdrawn if compliance with regulatory

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Protocol Assessment

company may reach an agreement with the FDA under the Special Protocol Assessment, or “SPA”, process as to the required design

and size of clinical trials intended to form the primary basis of an efficacy claim.

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Exclusivity and Pediatric Use

Best Pharmaceuticals for Children Act, or “BPCA”, provides NDA holders a six-month period of exclusivity attached to any

other exclusivity listed with the FDA — patent or non-patent — for a drug, if certain conditions

Best Pharmaceuticals for Children Act, or “BPCA”, provides NDA holders a six-month period of exclusivity attached to any

other exclusivity listed with the FDA — patent or non-patent — for a drug, if certain conditions

Conditions for pediatric exclusivity include a determination by the FDA that information relating to the use of a new drug in

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BPCA are treated as priority applications.

addition, under the Pediatric Research Equity Act, or “PREA”, NDAs or supplements to NDAs must contain data to assess the

safety and effectiveness of the drug for the claimed indications in all relevant pediatric subpopulations and to support dosing and administration

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keep a deferral current or fails to submit a request for approval of a pediatric formulation.

federal Controlled Substances Act of 1970, or “CSA”, and its implementing regulations establish a “closed system”

of regulations for controlled substances.

The CSA imposes registration, security, recordkeeping and reporting, storage, manufacturing,

distribution, importation and other requirements under the oversight of the DEA.

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

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.

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manufacturers of that substance.

Once registered, manufacturing facilities must maintain records documenting the manufacture, receipt

and distribution of all controlled substances.

Manufacturers must submit periodic reports to the DEA of the distribution of Schedules

I and II controlled substances, Schedule III narcotic substances, and other designated substances.

Registrants must also report any controlled

substance thefts or significant losses, and must obtain authorization to destroy or dispose of controlled substances.

As with applications

for registration as a bulk manufacturer, an application for an importer registration for a Schedule I or II substance must also be published

in the Federal Register, which remains open for 30 days for comments.

Imports of Schedules I and II controlled substances for commercial

purposes are generally restricted to substances not already available from a domestic supplier or where there is not adequate competition

among domestic suppliers.

In addition to an importer or exporter registration, importers and exporters must obtain a permit for every

import or export of a Schedules I and II substance or Schedules III, IV and V narcotic, and submit import or export declarations for

Schedules III, IV and V non-narcotics.

In some cases, Schedule III non-narcotic substances may be subject to the import/export permit

requirement, if necessary to ensure that the U.S.

complies with its obligations under international drug control treaties.

registered, manufacturing facilities must maintain records documenting the manufacture, receipt and distribution of all controlled substances.

Manufacturers must submit periodic reports to the DEA of the distribution of Schedules I and II controlled substances, Schedule III narcotic

substances, and other designated substances.

Registrants must also report any controlled substance thefts or significant losses, and

must obtain authorization to destroy or dispose of controlled substances.

with applications for registration as a bulk manufacturer, an application for an importer registration for a Schedule I or II substance

must also be published in the Federal Register, which remains open for 30 days for comments.

Imports of Schedules I and II controlled

substances for commercial purposes are generally restricted to substances not already available from a domestic supplier or where there

is not adequate competition among domestic suppliers.

In addition to an importer or exporter registration, importers and exporters must

obtain a permit for every import or export of a Schedules I and II substance or Schedules III, IV and V narcotic, and submit import or

export declarations for Schedules III, IV and V non-narcotics.

In some cases, Schedule III non-narcotic substances may be subject to

the import/export permit requirement, if necessary to ensure that the U.S.

complies with its obligations under international drug control

drugs manufactured in the U.S., the DEA establishes annually an aggregate quota for the amount of substances within Schedules I and II

that may be manufactured or produced in the U.S.

based on the DEA’s estimate of the quantity needed to meet legitimate medical,

scientific, research and industrial needs.

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and distribution of our product candidates, if approved.

or not we obtain FDA approval for a product, it must obtain the requisite approvals from regulatory authorities in non-U.S.

or not we obtain FDA approval for a product, we must obtain the requisite approvals from regulatory authorities in non-U.S.

prior to the commencement of clinical trials or marketing of the product in those countries.

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products is also responsible for controlled substances.

Responsibility is, however, split in some member states, such as the U.K.

any company manufacturing or distributing a medicinal product containing a controlled substance in the European Union will need to hold

a controlled substances license from the competent national authority and will be subject to specific record-keeping and security obligations.

Separate import or export certificates are required for each shipment into or out of the member state.

Responsibility is, however, split in some member states.

Generally, any company

manufacturing or distributing a medicinal product containing a controlled substance in the European Union will need to hold a controlled

substances license from the competent national authority and will be subject to specific record-keeping and security obligations.

import or export certificates are required for each shipment into or out of the member state.

Trials and Marketing Approval

or not we obtain FDA approval for a product, we would need to obtain the necessary approvals by the comparable regulatory authorities

of foreign countries before we can commence clinical trials or marketing of the product in those countries.

The approval process varies

from country to country and can involve additional product testing and additional administrative review periods.

The time required to

obtain approval in other countries might differ from and be longer than that required to obtain FDA approval.

Regulatory approval in

one country does not ensure regulatory approval in another, but a failure or delay in obtaining regulatory approval in one country may

negatively impact the regulatory process in others.

countries outside of the U.S.

have a process that requires the submission of a clinical trial application much like an IND prior to the

commencement of human clinical trials.

In Europe, for example, a clinical trial application, or “CTA”, must be submitted

to the competent national health authority and to independent ethics committees in each country in which a company intends to conduct

clinical trials.

Once the CTA is approved in accordance with a country’s requirements and a company has received favorable ethics

committee approval, clinical trial development may proceed in that country.

have a process that requires the submission of a clinical trial application much like an IND application

prior to the commencement of human clinical trials.

In Europe, for example, a clinical trial application, or “CTA”, must

be submitted to the competent national health authority and to independent ethics committees in each country in which a company intends

to conduct clinical trials.

Once the CTA is approved in accordance with a country’s requirements and a company has received favorable

ethics committee approval, clinical trial development may proceed in that country.

requirements and process governing the conduct of clinical trials, product licensing, pricing, and reimbursement vary from country to

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In all cases, the clinical trials must be conducted in accordance with the International

Conference on Harmonization, or “ICH”, guidelines on GCP and other applicable regulatory requirements.

obtain regulatory approval to place a drug on the market in European Union countries, Enveric must submit a marketing authorization application.

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valid throughout the European Union and, by extension (after national implementing decisions) in Iceland, Liechtenstein and Norway, which,

together with the European Union.

member states, comprise the European Economic Area, or “EEA”.

together with the European Union Member States, comprise the European Economic Area, or “EEA”.

Applicants file marketing

authorization applications with the EMA, where they are reviewed by a relevant scientific committee, in most cases the Committee for

Medicinal Products for Human Use (the “CHMP”).

The EMA forwards CHMP opinions to the European Commission, which uses them

as the basis for deciding whether to grant a marketing authorization.

This procedure results in a single marketing authorization granted

by the European Commission that is valid across the European Union, as well as in Iceland, Liechtenstein and Norway.

authorization applications with the EMA (European Medicines Agency), where they are reviewed by a relevant scientific committee, in most

cases the Committee for Medicinal Products for Human Use (the “CHMP”).

The EMA forwards CHMP opinions to the European Commission,

which uses them as the basis for deciding whether to grant a marketing authorization.

This procedure results in a single marketing authorization

granted by the European Commission that is valid across the European Union, as well as in Iceland, Liechtenstein and Norway.

The centralized

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a new active substance indicated for the treatment of certain diseases, such as HIV/AIDS, cancer, diabetes, neurodegenerative diseases,

autoimmune and other immune dysfunctions and viral diseases, (iii) officially designated “orphan drugs”

(drugs used for rare

autoimmune and other immune dysfunctions and viral diseases, (iii) officially designated “orphan drugs” (drugs used for rare

human diseases), and (iv) advanced-therapy medicines, such as gene-therapy, somatic cell-therapy or tissue-engineered medicines.

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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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Recognition Procedure

mutual recognition procedure, or “MRP”, for the approval of human drugs is an alternative approach to facilitate individual

national marketing authorizations within the European Union.

Basically, 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 member states.

characteristic of the MRP is that the procedure builds on an already-existing marketing authorization in a member state of the European

Union that is used as a reference in order to obtain marketing authorizations in other European Union member states.

In the MRP, 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 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

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 process.

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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Medicinal Products

EMA’s Committee for Orphan Medicinal Products (“COMP”) may recommend orphan medicinal product designation to promote

the development of products that are intended for the diagnosis, prevention or treatment of life-threatening or chronically debilitating

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product is sufficiently profitable not to justify maintenance of market exclusivity.

the European Union, companies developing a new medicinal product must agree to a Pediatric Investigation Plan, or “PIP”,

with the EMA and must conduct pediatric clinical trials in accordance with that PIP unless a waiver applies, for example, because the

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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, it 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.

continue to build on our leadership expertise.

We employ two full-time and one part-time employee.

We also work with scientific

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

We continue to build on our

leadership expertise.

We employ 23 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.

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

Other than as described below,

we do not have any pending litigation that, separately or in the aggregate, would, in the opinion of management, have a material

adverse effect on its results of operations, financial condition or cash flows.

January 21, 2021, we received a stockholder litigation demand letter from the law firm of Purcell Julie & Lefkowitz LLP,

on behalf of James Self, a purported stockholder of our Company.

The letter demands that we (i) deem ineffective the December

30, 2020 amendment to its Amended and Restated Certificate of Incorporation in which we effected a reverse stock split due to

the manner in which non-votes by brokers were tabulated, (ii) seek appropriate relief for damages allegedly suffered by the

company and its stockholders or seek a valid stockholder approval of the amendment and reverse stock split, and (iii) adopt

adequate internal controls to prevent a recurrence of the alleged misconduct.

We dispute that the amendment was ineffective

or that there were any inadequate internal controls related to the same.

However, to eliminate any questions about the

amendment, we intend to seek to ratify the amendment at a special stockholders’

meeting pursuant to Section 204 of the

Delaware General Corporation Law.

This special stockholders’

meeting is scheduled to occur on May 14, 2021.

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