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Item 1. Business

2024-03-26 compared with 2023-03-31 · 240 added, 346 removed, 634 unchanged (48% of the section changed)

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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.

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

The Amalgamation was completed on September

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

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

Available Information

We are required to file Annual

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

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

The SEC maintains an Internet website that

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

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

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

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

March 21, 2023, the Company established Enveric Therapeutics, an Australia-based subsidiary, to support the Company’s plans to

advance its lead program, the EVM201 Series, comprised of the next generation synthetic prodrugs of the active metabolite, psilocin (“EVM201

Series”), towards the clinic.

Enveric Therapeutics will oversee the Company’s preclinical, clinical, and regulatory activities

in Australia, including ongoing interactions with the local Human Research Ethics Committees (“HREC”) and the Therapeutic Goods Administration

(“TGA”), Australia’s regulatory authority.

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

“SEC”) on a regular basis, and are required to disclose certain material events in Current Reports on Form 8-K.

The SEC maintains

an Internet website that contains reports, proxy and information statements and other information regarding issuers that file electronically

with the SEC.

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

We also make available, free of charge, our Annual Report

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

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

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

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

We seek to improve the lives of patients suffering from

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

treatment such as pain or skin irritation.

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

following approval through established regulatory pathways.

Agreement with MagicMed Industries Inc.

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 199,025 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 148,083 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.

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

anxiety, and addiction disorders.

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

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

Our lead program, the EVM201 Series,

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

We are developing the first product from the EVM201

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

We are also advancing its second program, the EVM301 Series

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

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

our amalgamation with MagicMed completed in September 2021 (the “Amalgamation”), we have continued to pursue the development

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the right drug candidates needed to address mental health challenges, including anxiety.

We synthesize novel versions

of classic psychedelics, such as psilocybin, N-dimethyltryptamine (DMT), mescaline and MDMA, using a mixture of chemistry and synthetic

biology, resulting in the expansion of the Psybrary™, which includes 15 patent families with over a million potential variations

and hundreds of synthesized molecules.

Within the Psybrary™ we have three different types of molecules, Generation 1 (classic psychedelics),

Generation 2 (pro-drugs), and Generation 3 (new chemical entities).

The Company is working to add novel psychedelic molecular compounds

and derivatives (“Psychedelic Derivatives”) on a regular basis through our work at Enveric Labs in Calgary, Alberta, Canada,

where we have a team of PhD scientists with expertise in synthetic biology and chemistry.

To date we have created over 500 molecules

that are housed in the Psybrary™.

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

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.

and Related Private Placement

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

Biosciences, Inc.

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

(the “Spin-Off”).

The Spin-Off will be subject to various conditions, including Akos meeting the qualifications for

listing on the Nasdaq Stock Market, and if successful, would result in two standalone public companies.

The primary assets and

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

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

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

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

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

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

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

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

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

We synthesize novel versions of classic psychedelics,

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

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

Within the Psybrary™ we have three different types of molecules, Generation 1 (classic psychedelics), Generation 2 (pro-drugs),

and Generation 3 (new chemical entities).

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

Derivatives”) that are housed in the Psybrary™.

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

out-license other molecules from the Psybrary™.

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

(formerly known as Acanna Therapeutics, Inc.), a majority-owned subsidiary of the Company (hereafter referred to as “Akos”),

which was incorporated on April 13, 2022, by way of dividend to Enveric shareholders (the “Spin-Off”).

As of May 12, 2023,

the holders of the Company’s Akos Series A Preferred Stock, par value $0.01 per share (“Akos Series A Preferred Stock”)

have exercised this right to force redemption of all of the Akos Series A Preferred Stock for $1,000 per share, plus accrued but unpaid

dividends of $52,057 for a total of $1,052,057.

The Company made full payment on May 19, 2023.

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

CBD + Celecoxib Conjugate

Osteoarthritis

& Development, Lead Optimization

of two molecular conjugates EV104a and EV104b

Second-generation

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prodrug of psilocin

& Development, Lead Optimization

and in-vivo experimentation

of HREC for FIH study in Australia

Third-generation

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health indication

& Development, Hit-to-Lead Generation

experimentation

Cannabinoid-Infused

Topical Product

Oncology-related

skincare conditions (e.g., radiodermatitis)

Center of Excellence

& Development/Discovery

Exploratory Phase 1/2 trial

and COX-2 inhibitor Conjugation

conjugated New Chemical Entity

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

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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 anxiety, 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:

● Glycosylated

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

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

In addition, Enveric has intellectual

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

The Enveric intellectual

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

treatment of cancer.

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

Derivatives .

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

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

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

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

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

Derivatives – EVM 501 Series.

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

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

Derivatives – EVM 401 Series .

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

derivatives and methods of treatment using MDMA derivatives.

portfolios include the following published and unpublished applications:

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

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

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

Relates to glycosylated

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

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

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

● Halogenated

Psilocybin Derivatives and Methods of Using (WO2022047579)

Relates to halogenated psilocybin

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

cell surface receptor, and methods for treating psychiatric disorders.

● Hydroxylated

Psilocybin Derivatives and Methods of Using (WO2022047580)

Relates to hydroxylated psilocybin

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

cell surface receptor.

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

Relates to nitrated psilocybin

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):

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

hold limited rights to several plant patent applications as an in-licensee of Tikun Olam.

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

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

hold limited rights to use the data included in the Tikun Olam patient database.

Psilocybin Derivatives and Methods of Using (WO2023044556A1)

Psilocybin Derivatives and Methods of Using (WO2022104475A1)

Psilocybin Derivatives and Methods of Using (WO2022115944)

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

Psilocybin Derivatives and Methods of Using (WO2022155751)

Multi-substituent

Psilocybin Derivatives and Methods of Using (WO2022170438)

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

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

Substituted Tryptamine Derivatives and Methods of Using (WO2023/173227A1) - This application relates to several groups of novel

C4-substituted tryptamine derivative compounds and pharmaceutical drug formulations containing C4-ether-substituted tryptamine derivative

compounds, C4-carbonic ester- substituted tryptamine derivative compounds, C4-polyether substituted tryptamine derivative compounds,

and C4-phosphate substituted tryptamine derivative compounds.

These pharmaceutical formulations may be used to treat psychiatric

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

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

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

Derivatives – EVM 501 Series.

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

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

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

Heterocyclic Mescaline Derivatives ( WO2024026568A1)

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

and PCT/CA2023/051670

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

Derivatives – EVM 401 Series.

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

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

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

Mescaline Derivatives and Methods of Using (WO2023/102658)

Isopropylamine

Analogues of Glycosylated Mescaline Derivatives (WO2023/102659)

Phosphorylated

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

Isopropylamine

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

Assisted Drug Discovery

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

patent application)

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

All cannabinoid-related technology, intellectual property, and

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

The Akos cannabinoid portfolios have three focus areas:

molecules for the treatment of pain;

cancer treatment comprising combination treatment;

and topical creams for treating the effects of

cancer radiation.

Cannabinoid-Conjugates .

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

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

Two patent families in-licensed

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

applications.

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

States patent applications, and one pending PCT application.

Conjugate Molecules (WO2020263888A1) (In-licensed)

Molecules (WO2021076197A1) (In-licensed)

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

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

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

applications.

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

Administration

regimes of cannabinoids in combination with chemotherapeutics against cancer (WO2021028646A1

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

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

The patent family includes one pending United States

patent application and one pending PCT application.

for Topical Treatment of Radiation Dermatitis (WO2023154264A1)

Biotech, Inc.

hold limited rights to patent applications owned by Diverse Biotech, Inc.

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

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

for the use of cannabinoids in conjugate form with five existing,

standard-of-care drugs (celecoxib and four selected steroids) via Diverse Biotech’s patent pending conjugate drug delivery platform.

Our rights extend to all fields of use.

engage in targeted research and development to apply such conjugates to alleviate the side effects that cancer patients experience, with

the goal of achieving novel therapeutic outcomes for patients.

Diverse Biotech, Inc.

patent application portfolio includes two patent applications licensed to us.

Those two patent applications disclose

conjugate chemistry that combines cannabinoids with existing drugs in conjugate form that we believe will provide differentiation in

use and efficacy from combination therapy of drugs and cannabinoids.

The license extends for as long as Enveric intends to develop and

commercialize the licensed Agents and Products.

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

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;

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:

● Compositions

for Topical Treatment of Radiation Dermatitis:

(US Provisional Applications, unpublished):

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

of radiodermatitis.

● Compositions

for Topical Treatment of Radiation Dermatitis:

(US Provisional Applications, unpublished):

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

of radiodermatitis.

● Cannabinoid

Conjugate Molecules:

(Three US Provisional Applications, unpublished):

Relates to conjugate

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

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

Supply Agreement

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.

The intended target for development of such conjugates is alleviating pain, specifically the

pain of osteoarthritis, rheumatoid arthritis, and cancer, with the goal of achieving improved and novel therapeutic outcomes for patients.

in-licensed Diverse Biotech, Inc.

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

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

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

The license extends for as long

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

The patent applications, should they issue, may expire

as late as 2040.

& Development

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

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

institutions.

view of the urgent need for new and more effective mental health 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

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.

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

towards the clinic.

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

EB-373 is the lead drug candidate from the EVM201 Series currently advancing through preclinical development with the aim of initiating

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

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

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

metabolite of psilocybin.

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

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

EB-003 is a next

generation analog of DMT.

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

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

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

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

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

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

our product candidates.

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

and finalization of commercial plans.

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

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

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

Under the agreement, Avance Clinical will manage the

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

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

next-generation proprietary psilocin prodrug, has been recognized as a New Chemical Entity (NCE) by Australia’s Therapeutic Goods

Administration (TGA) and is currently in preclinical development targeting the treatment of anxiety disorder.

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

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

connection with our product candidates.

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

filings, approval and finalization of commercial plans.

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

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

Under the agreement, Avance Clinical will manage the Phase

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

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

EB-002, a next-generation

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

in preclinical development targeting the treatment of anxiety disorder.

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

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

Advisory Board

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Stahl, M.D., Ph.D.

of Psychopharmacology forthe California Department of State Hospitals

of Psychopharmacology for the California Department of State Hospitals

DeWitt, Ph.D.

Chair, President & CEO of DeuteRx,

President & CEO of DeuteRx, LLC;

COO of Neuromity Therapeutics, Inc.;

Founder of RIFFIT, Inc.

Professor, St.

George’s University of London

Therapeutics R&D

Krystal, M.D.

of Yale Center for Clinical Investigation

Liebowitz, M.D.

of Psychiatry;

Director at Medical Research Network

has served as a Scientific Advisor of Enveric since 2022.

Maurizio Fava is Psychiatrist-in-Chief of the Massachusetts

General Hospital (MGH), executive director of the Clinical Trials Network and Institute, (MGH), associate dean for clinical and translational

research, and the Slater Family Professor of Psychiatry at Harvard Medical School.

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

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

Fava is a world leader in the field of depression.

He has edited eight books and authored or co-authored more than 900 original articles published in medical journals with international

circulation, articles which have been cited more than 95,000 times in the literature and with an H index greater than 150.

and was director of MGH’s Depression Clinical and Research Program from 1990 until 2014.

Fava’s direction, the

Depression Clinical and Research Program became one of the most highly regarded depression programs in the country, a model for academic

programs that link, in a bi-directional fashion, clinical and research work.

In 2007, he also founded and is now the executive director

of the MGH Psychiatry Clinical Trials Network and Institute, the first academic CRO specialized in the coordination of multi-center clinical

trials in psychiatry.

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

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

and with an H index greater than 150.

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

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

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

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

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

Stahl, M.D., Ph.D.

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has served as a Scientific Advisor of Enveric since 2022.

John Krystal is the Robert L.

McNeil, Jr., Professor

of Translational Research;

is the Robert L.

McNeil, Jr., Professor of Translational Research;

Professor of Psychiatry, Neuroscience, and Psychology;

Chair of the Department of Psychiatry at Yale University;

Department of Psychiatry at Yale University;

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

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

of Medicine, and the Yale Psychiatry Residency Training Program.

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

alcoholism, PTSD, and depression.

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

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

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

He is a graduate

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

He has published extensively

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

Notably, his laboratory discovered the rapid antidepressant

effects of ketamine in humans.

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

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

He is a member of the U.S.

National Academy of Medicine;

of the Neuroscience Forum of the U.S.

Academy of Medicine;

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

National Academies of Sciences, Engineering, and Medicine;

Fellow of the American Association for

the Advancement of Science (AAAS);

and editor of Biological Psychiatry (IF=13.382).

of the American Association for the Advancement of Science;

and editor of Biological Psychiatry.

Previously, Dr.

Krystal chaired the NIMH Board of

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

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

of Neuropsychopharmacology (CINP).

Liebowitz, M.D.

has served as a Scientific Advisor of Enveric since 2022.

Michael Liebowitz is a Professor of Psychiatry at Columbia

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

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

Liebowitz completed his

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

for atypical depression.

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

anxiety disorders in the United States.

Over the next two decades, Dr.

Liebowitz and colleagues helped refine treatments for panic disorder,

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

comparing medications and behavioral treatments for several anxiety disorders.

Liebowitz developed the Liebowitz Social Anxiety Scale

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

as a research and clinical measure.

and Industry Partners

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

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

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

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.

University of Calgary

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

Krystal chaired the NIMH

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

Advisory Council.

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

College of Neuropsychopharmacology.

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

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

primary academic partner is the University of Calgary which 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

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

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,

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of controlled substances to illicit channels of commerce.

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

V — with varying qualifications for listing in each schedule.

Schedule I substances by definition have a high

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

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

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

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

Pharmaceutical products having a currently accepted

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

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

the lowest relative potential for abuse and dependence.

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

varying qualifications for listing in each schedule.

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

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

Marijuana and psychedelics

such as psilocybin, DMT, mescaline and MDMA are currently Schedule I controlled substances, which means that no preclinical or clinical

studies of product candidates containing these substances may be conducted in the United States without the required DEA registration(s)

and related approvals, as applicable.

Pharmaceutical products having a currently accepted medical use that are otherwise approved for

marketing may be listed as Schedule II, III, IV or V substances, with Schedule II substances presenting the highest potential for abuse

and physical or psychological dependence, and Schedule V substances presenting the lowest relative potential for abuse and dependence.

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

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scientific, research and industrial needs.

This limited aggregate amount of cannabis that the DEA allows to be produced in the U.S.

year is allocated among individual companies, which, in turn, must annually apply to the DEA for individual manufacturing and procurement

The quotas apply equally to the manufacturing of the active pharmaceutical ingredient and production of dosage forms.

may adjust aggregate production quotas a few times per year, and individual manufacturing or procurement quotas from time to time during

the year, although the DEA has substantial discretion in whether or not to make such adjustments for individual companies.

states also maintain separate controlled substance laws and regulations, including licensing, recordkeeping, security, distribution,

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

control of narcotic substances, including cannabis extracts.

Countries may interpret and implement their treaty obligations in a way

that creates a legal obstacle to us obtaining marketing approval for our product candidates in those countries.

These countries may not

be willing or able to amend or otherwise modify their laws and regulations to permit our product candidates to be marketed, or achieving

such amendments to the laws and regulations may take a prolonged period of time.

In that case, we would be unable to market our product

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

continue to build on our leadership expertise.

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

We also work with scientific

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

control of narcotic substances.

Countries may interpret and implement their treaty obligations in a way that creates a legal obstacle

to us obtaining marketing approval for our product candidates in those countries.

These countries may not be willing or able to amend

or otherwise modify their laws and regulations to permit our product candidates to be marketed, or achieving such amendments to the laws

and regulations may take a prolonged period of time.

In that case, we would be unable to market our product candidates in those countries

in the near future or perhaps at all.

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

As of the date

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

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

academic institutions and contract research organizations.

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

1 unchanged sentence

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