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Item 1. Business

2024-05-01 compared with 2023-04-26 · 498 added, 386 removed, 78 unchanged (92% of the section changed)

6 unchanged sentences

abuse deterrent transdermal technology that we believe can be incorporated into existing transdermal patches that contain drugs that are

susceptible to abuse and misuse.

We operate in two distinct business segments:

pharmaceuticals and medical devices.

The following is a description of the Company’s revenue types:

service revenues, which include the contracting of research and development related services with the Company’s clients in the life

sciences field on an as-needed basis;

and contract manufacturing revenues, which are derived from the manufacture and production of products

for a number of customers in the health, wellness and pharmaceutical space.

We manage and evaluate our operations, and report our financial

results, through these two business segments.

Our principal offices are located in Orlando, Florida, and we primarily

operate and derive most of our revenues in the United States.

Our lead product under development is AVERSA Fentanyl, an abuse deterrent

fentanyl transdermal system that combines an approved generic fentanyl patch with our AVERSA abuse deterrent technology to reduce the

abuse and misuse of fentanyl patches.

We believe that AVERSA technology can be broadly applied to various transdermal products, and our

plan is to follow the development of our abuse deterrent fentanyl transdermal system with the development of additional transdermal abuse

deterrent products for pharmaceuticals that have a risk or history of abuse.

Specifically, we have expanded our development pipeline to

include AVERSA Buprenorphine and AVERSA Methylphenidate.

In addition, we are developing a portfolio of transdermal pharmaceutical products

to deliver already approved drugs or biologics that are typically delivered by injection but with the potential to improve compliance

and therapeutic outcomes through transdermal delivery.

We have a feasibility agreement with Kindeva Drug Delivery, formerly

3M Drug Delivery (“Kindeva”), for the development of AVERSA Fentanyl using Kindeva’s FDA approved Fentanyl patch.

feasibility agreement is focused on adapting Kindeva’s commercial transdermal manufacturing process to incorporate AVERSA abuse

deterrent technology.

The product development program for AVERSA Fentanyl includes performing

preclinical and clinical studies to demonstrate the abuse deterrent properties of the product.

The program assumes that the fentanyl transdermal

system is already approved and the only change to the approved product will be to incorporate the AVERSA technology into the patch design

with no change being made to the fentanyl drug matrix or its demonstrated safety, patch performance or drug release characteristics.

studies to be performed primarily consist of laboratory-based in vitro manipulation and extraction studies in various extraction media

per FDA guidance.

Clinical evaluation primarily consists of a Phase 1 Human Abuse Liability (HAL) study to demonstrate the abuse potential

of the product per FDA guidance.

The regulatory path for FDA approval is planned to be a 505(b)(2) NDA submission to access the safety

and efficacy information on file for Duragesic ® fentanyl transdermal system as the reference-listed drug and to be able

to obtain approval for abuse deterrent claims as a branded pharmaceutical product.

The product development program for the additional AVERSA pipeline

products, AVERSA Buprenorphine and AVERSA Methylphenidate, are similar to that of AVERSA Fentanyl, assuming that the AVERSA technology

is incorporated into an already approved transdermal patch.

Through January 31, 2023, we had not generated any revenue from our

transdermal consumer patches.

Consumer products are products that can be sold over-the-counter and do not require a prescription.

transdermal patches are considered drugs in the United States and cannot be marketed in the United States without approval from the FDA.

We have not taken any steps to seek to obtain FDA approval for any of our consumer products in development that would permit sales of

those products in the United States, and we have no plans to do so in the near term.

susceptible to abuse and misuse such as opioid and stimulant drugs.

The Company’s revenues are based on providing

services through our subsidiaries Pocono Pharmaceuticals operating as Active Intelligence and 4P Therapeutics.

Pocono Pharmaceuticals provides

contract manufacturing services for health, wellness and over-the-counter pharmaceutical customers and 4P Therapeutics performs contract

research and development related services for pharmaceutical and medical devices customers.

We manage and evaluate our operations, and

report our financial results, through these two separate subsidiaries.

Our principal offices are located in Orlando,

Florida, and our subsidiary, Pocono Pharmaceuticals, has a manufacturing facility in Cherryville, North Carolina.

We primarily operate and derive

most of our revenues in the United States.

Recent Development

On April 19, 2024, the Company completed an $8,400,000

equity financing with European investors (the “Offering”) of 2,100,000 units (“Units”), at a price of $4.00 per

Unit, each Unit consisting of one share of common stock (“Shares”) and a Warrant to purchase two Shares of common stock, the

Warrants having an initial exercise price of $6.43, are exercisable by payment of the exercise price in cash only and expire April 19,

2029, five years from the date of issuance (“Warrants”).

The Offering was made solely to investors resident outside the United

States and was not registered under the Securities Act of 1933, as amended (the “Securities Act”), or the securities laws of

any jurisdiction, including any jurisdiction outside the United States, but was made privately by the Company pursuant to the exemptions

from registration provided in the SEC’s Regulation S and other exemptions under the Securities Act.

AVERSA Abuse Deterrent Transdermal Products

Our lead product under development is AVERSA

Fentanyl, an abuse deterrent fentanyl transdermal system that combines an approved generic fentanyl patch with our AVERSA abuse

deterrent transdermal technology to reduce the abuse and misuse of fentanyl patches.

We believe that our AVERSA technology can be

broadly applied to various transdermal products, and our plan is to follow the development of AVERSA Fentanyl with the development

of additional abuse deterrent transdermal products for pharmaceuticals that have a risk or history of abuse, misuse or accidental

Specifically, we have expanded our development pipeline to include AVERSA Buprenorphine and AVERSA Methylphenidate.

addition, we are developing a portfolio of transdermal pharmaceutical products to deliver already approved drugs or biologics that

are typically delivered by injection but with the potential to improve compliance and therapeutic outcomes through transdermal

In January 2024, we signed a commercial development

and clinical supply agreement with Kindeva Drug Delivery, formerly 3M Drug Delivery (“Kindeva”), for the development of AVERSA

Fentanyl using Kindeva’s FDA-approved fentanyl patch.

This agreement replaced the previous feasibility agreement between the two

companies which was focused on establishing the feasibility of incorporating our AVERSA abuse deterrent transdermal technology into Kindeva’s

commercial transdermal manufacturing process.

The commercial development and clinical supply agreement is focused on developing the commercial

manufacturing process for AVERSA Fentanyl.

The product development program for AVERSA Fentanyl

includes performing preclinical and clinical studies to demonstrate the abuse deterrent properties of the product.

The development program

is based on the fact that the fentanyl transdermal system is already approved and the only change to the approved product will be to

incorporate the AVERSA technology into the patch design with no change being made to the fentanyl drug matrix or its demonstrated safety,

patch performance or drug release characteristics.

Preclinical studies to be performed consist of laboratory-based in vitro manipulation

and chemical extraction studies per FDA guidance.

Clinical evaluation consists of a Phase 1 human abuse potential study to demonstrate

the abuse potential of the product per FDA guidance.

The regulatory path to FDA approval is planned to be a 505(b)(2) NDA submission

to access the safety and efficacy information on file for the Duragesic ® fentanyl transdermal system as the reference-listed

drug and to be able to obtain approval for abuse deterrent claims as a branded pharmaceutical product.

The product development program for the additional

AVERSA pipeline products, AVERSA Buprenorphine and AVERSA Methylphenidate, are similar to that of AVERSA Fentanyl, assuming that the AVERSA

technology is incorporated into an already approved transdermal patch.

Acquisition of 4P Therapeutics

Pursuant to an acquisition agreement dated April 5, 2018 between us

and 4P Therapeutics, on August 1, 2018, we acquired all of the equity interest in 4P Therapeutics from Steven Damon, the owner of 4P Therapeutics.

The purchase price of $2,250,000, consisting of 62,500 shares of common stock, valued at $1,850,000, and cash of $400,000, and are to

Damon a 6% royalty on any revenue we receive or derive from our utilization or sale of the abuse deterrent intellectual property

that we acquired as a part of the assets 4P Therapeutics, including partner license milestones and development payments.

The royalty is

payable pursuant to the acquisition agreement and continues as long as we generate revenue from our utilization or sale of the abuse deterrent

intellectual property we acquired as part of the acquisition of 4P Therapeutics.

The 62,500 shares were issued to Mr.

Damon (41,750 shares

pre-split) and Dr.

Pursuant to an acquisition agreement dated April

5, 2018 between us and 4P Therapeutics, on August 1, 2018, we acquired all of the equity interest in 4P Therapeutics from Steven Damon,

the owner of 4P Therapeutics.

The purchase price of $2,250,000, consisting of 62,500 shares of common stock, valued at $1,850,000, and

cash of $400,000, and are to pay Mr.

Damon a 6% royalty on any revenue we receive or derive from our utilization or sale of the abuse

deterrent intellectual property that we acquired as a part of the assets 4P Therapeutics, including partner license milestones and development

The royalty is payable pursuant to the acquisition agreement and continues as long as we generate revenue from our utilization

or sale of the abuse deterrent intellectual property we acquired as part of the acquisition of 4P Therapeutics.

The 62,500 shares were

issued to Mr.

Damon (41,750 shares pre-split) and Dr.

Alan Smith (20,750 shares pre-split).

In connection with the acquisition, Mr.

Damon retained any cash and accounts

receivable and assumed any liabilities other than those relating to the ongoing business.

Pursuant to the acquisition agreement, we appointed

Damon to our board of directors in April 2018, when we signed the acquisition agreement, and we agreed to pay Mr.

Damon the compensation

received by independent board members.

As a result of the acquisition, the focus of our business has changed

from the development and marketing outside of the U.S.

of consumer transdermal products to the development of 4P Therapeutics’ portfolio

of pharmaceutical transdermal products.

Our lead product under development is AVERSA ® Fentanyl (abuse deterrent fentanyl

transdermal system) which we plan to develop to deter the abuse and accidental misuse of fentanyl transdermal patches.

Fentanyl is a potent

synthetic opioid that is marketed as a transdermal patch for chronic pain management.

There are currently a number of generic fentanyl

patches on the market but none of them have abuse deterrent properties.

We believe that our AVERSA ® abuse deterrent technology,

containing aversive agents will significantly deter the abuse and accidental misuse of fentanyl from transdermal patches.

With the acquisition of 4P Therapeutics, we acquired a research pipeline

of other transdermal products, including peptides and proteins such as exenatide for type 2 diabetes and FSH for infertility.

are off patent but are currently only available as injections, and we are evaluating the possibility of developing a transdermal delivery

system for these drugs as an alternative to injection but with improved compliance and safety.

In addition, we may develop certain generic

transdermal products where we think we can make an improvement to existing patches and where we believe we can take significant market

share with good profit margins.

The prioritization of our portfolio product candidates will be reviewed on an ongoing basis and will take

into account technical progress, market potential and R&D funding available.

We cannot assure you that we will be able to develop

and obtain FDA approval for any of these potential products or that we can be successful in marketing any such products.

The FDA approval

process can take many years to complete successfully, and we will require substantial funding for each product that goes through the process.

retained any cash and accounts receivable and assumed any liabilities other than those relating to the ongoing business.

the acquisition agreement, we appointed Mr.

Damon to our board of directors in April 2018, when we signed the acquisition agreement.

Damon resigned as a director in January 2022.

As a result of the acquisition, the focus of

our business changed from the development and marketing outside of the U.S.

of consumer transdermal products to the development of 4P

Therapeutics’ portfolio of pharmaceutical transdermal products.

Our lead product under development is AVERSA ® Fentanyl

(abuse deterrent fentanyl transdermal system) which we plan to develop to deter the abuse and accidental misuse of fentanyl transdermal

Fentanyl is a potent synthetic opioid that is marketed as a transdermal patch for chronic pain management.

There are currently

several generic fentanyl patches on the market but none of them have abuse deterrent properties.

We believe that AVERSA Fentanyl, once

approved by the US FDA will significantly deter the abuse and accidental misuse of fentanyl transdermal patches.

With the acquisition of 4P Therapeutics, we acquired

a research pipeline of other transdermal products, including novel transdermal products that involve delivery of peptides and proteins

through the skin.

These drugs are off patent but are currently only available as injections, and we are evaluating the possibility of

developing a transdermal delivery system for these drugs as an alternative to injection but with improved compliance and safety.

we may develop certain generic passive transdermal products where we think we can make an improvement to existing patches and where we

believe we can take significant market share with good profit margins.

The prioritization of our portfolio product candidates will be

reviewed on an ongoing basis and will take into account technical progress, market potential and R&D funding available.

assure you that we will be able to develop and obtain FDA approval for any of these potential products or that we can be successful in

marketing any such products.

The FDA approval process can take many years to complete successfully, and we will require substantial funding

for each product that goes through the process.

We cannot assure you that we will obtain FDA marketing approval for any of our products.

In addition to performing research and development for its own products,

4P Therapeutics performs contract research and development services for a small number of clients in the life sciences field to help support

its ongoing operations.

The work includes conducting early-stage drug and device clinical and preclinical studies and providing clinical-regulatory

and formulation/analytical consulting services.

Neither we nor current clients have any long-term commitments, and either party can terminate

In addition to performing research and development

for its own products, 4P Therapeutics performs contract research and development services for a small number of clients in the life sciences

field to help support its ongoing operations.

The work includes conducting early-stage drug and device clinical and preclinical studies

and providing clinical-regulatory and formulation/analytical consulting services.

Neither we nor current clients have any long-term commitments,

and either party can terminate at any time.

We do not expect to generate significant revenues from these services.

Acquisition of Pocono Coated Products

On August 25, 2020, the Company formed Pocono Pharmaceuticals Inc.(“Pocono”),

a wholly owned subsidiary of the Company.

Effective August 31, 2020, the Company entered into a Purchase Agreement (“Agreement”)

with Pocono Coated Products (“PCP”), a manufacturer of Topical and transdermal products, pursuant to which PCP agreed to sell

the Company certain of the assets and liabilities associated with its Transdermal, Topical, Cosmetic and Nutraceutical business (the “Business”),

including all related equipment, intellectual property and trade secrets, cash balances, receivables, bank accounts and inventory.

net assets were contributed to Pocono.

Included in the transaction, the Company acquired 100% of the membership interests of Active Intelligence

LLC (“Active Intelligence”).

The purchase price for the assets of the Business is (i) $6,000,000 paid in 608,519 shares of

the Company’s common stock, based on the average price for the Company’s common stock for the previous 90 days as of the date

of Closing (the “Shares”);

(ii) a promissory note of the Company in the principal amount of $1,500,000, which has been paid

in full as of October 1, 2021.

On August 25, 2020, the Company formed Pocono

Pharmaceuticals Inc.(“Pocono”), a wholly owned subsidiary of the Company.

Effective August 31, 2020, the Company entered into

a Purchase Agreement (“Agreement”) with Pocono Coated Products (“PCP”), a manufacturer of topical and transdermal

products, pursuant to which PCP agreed to sell the Company certain of the assets and liabilities associated with its Transdermal, Topical,

Cosmetic and Nutraceutical business (the “Business”), including all related equipment, intellectual property and trade secrets,

cash balances, receivables, bank accounts and inventory.

The net assets were contributed to Pocono.

Included in the transaction, the Company

acquired 100% of the membership interests of Active Intelligence LLC (“Active Intelligence”).

The purchase price for the assets

of the Business is (i) $6,000,000 paid in 608,519 shares of the Company’s common stock, based on the average price for the Company’s

common stock for the previous 90 days as of the date of Closing;

(ii) a promissory note of the Company in the principal amount of $1,500,000,

which has been paid in full as of October 1, 2021.

Our Organization

We are a Nevada corporation, incorporated on January

2016, we acquired Nutriband Ltd, an Irish company which was formed by Gareth Sheridan, our chief executive officer, in 2012, to enter

the health and wellness market by marketing transdermal patches.

In January 2016, we acquired Nutriband Ltd, an Irish company which was formed by Gareth Sheridan, our chief executive officer,

in 2012, to enter the health and wellness market by marketing transdermal patches.

Our corporate headquarters are located at 121 S.

Orlando, Florida 32801, telephone (407) 377-6695.

Suite 1500, Orlando, Florida 32801, telephone (407) 377-6695.

Our website is www.nutriband.com .

Information contained on or available through

our website or any other website does not constitute a portion of this annual report.

Effects of the COVID-19 Pandemic

Our business may be affected by the COVID-19 pandemic and the response

to the pandemic.

Factors which may affect our business include, but are not limited to, the following:

The decision by investors who would invest in early-stage pharmaceutical companies to limit their financing efforts to companies that are dealing with products or services related to COVID-19 diagnosis or treatment.

The effect of recent stock market declines on the willingness of investors to make an investment in our securities.

The financial health of our potential contract service customers.

Our ability to perform contract services.

Our ability to obtain any goods or services which we may need to perform contract services.

The ability of our foreign distributors to obtain regulatory approval, which may be affected by the regulatory agencies giving a low priority to products such as our consumer patches.

Information contained on or

available through our website or any other website does not constitute a portion of this annual report.

Pharmaceutical Products in Development

We have a pipeline of transdermal pharmaceutical products that are

primarily in the early stages of development.

Our current focus is on the development of AVERSA Fentanyl for which we have a feasibility

agreement with Kindeva Drug Delivery, a contract development and manufacturing organization.

We plan to follow on from this with development

of additional products utilizing the AVERSA abuse deterrent transdermal technology, namely, AVERSA Buprenorphine and AVERSA Methylphenidate.

AVERSA Fentanyl is an abuse deterrent fentanyl patch for the treatment

of chronic pain.

As the United States faces an epidemic of opioid abuse, fentanyl transdermal patches have become an attractive target

for recreational drug abusers due to the high potency of fentanyl and its ease of abuse by the oral route.

We are looking to utilize our

proprietary approach to incorporate aversive agents into the transdermal patch to deter the abuse of fentanyl patches by the oral, buccal

and inhaled routes, which represent as much as 70% of all transdermal fentanyl abuse.

The technology is based on the incorporation of

taste and sensory aversive agents into the patch that are intended to make abuse a very unpleasant experience thereby deterring the recreational

abuse of fentanyl patches.

These aversive agents have high potency, established safety, and the potential to prevent accidental misuse

by children and pets.

The aversive agents are coated onto the backing of the transdermal patch in a controlled release formulation that

provides immediate and sustained release of aversive agents.

This provides several advantages including having a physical separation of

the aversive agents from the drug matrix, availability of aversive agents even after the patch is used and making it difficult to separate

the aversive agents from the drug by extraction.

The aversive agents are not contained in the drug matrix and are not delivered to the

skin during patch wear.

In addition to the fentanyl patch, this technology has broad applicability to any patch where deterring abuse

as well as accidental misuse by children and pets are valuable attributes.

We believe that our abuse deterrent technology can be broadly applied

to various transdermal products and our strategy is to follow the development of our AVERSA Fentanyl with the development of additional

products for pharmaceuticals that have a risk or history of abuse.

For example, we believe that our technology can be utilized in other

transdermal products to deter the abuse of other drugs such as buprenorphine, an opioid used to treat acute pain and chronic pain, and

methylphenidate, a central nervous system stimulant.

We have a pipeline of transdermal

pharmaceutical products that are primarily in the early stages of development.

Our current focus is on developing our AVERSA abuse

deterrent transdermal patch products.

Our lead product is AVERSA Fentanyl for which we have a commercial development agreement with

Kindeva Drug Delivery, a contract development and manufacturing organization.

We plan to follow on from this with the development of

additional products utilizing the AVERSA abuse deterrent transdermal technology, namely, AVERSA Buprenorphine and AVERSA

Methylphenidate.

Transdermal patches containing opioid and stimulant

drugs are designed to provide an alternative route of administration for treatment of conditions such as chronic pain, opioid use disorder

or attention deficit/hyperactivity disorder.

Although transdermal versions offer improved pharmacokinetic delivery as well as patient

convenience with wear times of up to 7 days, they contain an increased drug payload which can often be a target for recreational drug

abusers or subject to accidental pediatric exposure, particularly with infants and toddlers.

Abuse of opioids in general, and in particular

fentanyl abuse and overdose, continues to be an epidemic which can lead to the abuse of prescription transdermal fentanyl and other opioid

containing transdermal products.

AVERSA Fentanyl is an abuse deterrent fentanyl

patch for the treatment of chronic pain.

As the United States faces an epidemic of opioid abuse, fentanyl transdermal patches have become

an attractive target for recreational drug abusers due to the high potency of fentanyl, the high drug content contained in patches designed

for delivery over three days, and its ease of abuse by the oral route.

We are looking to utilize our proprietary approach to incorporate

aversive agents into the transdermal patch to deter the abuse of fentanyl patches by the oral, buccal and inhaled routes, which represent

as much as 70% of all transdermal fentanyl abuse.

The technology is based on the incorporation of taste and sensory aversive agents into

the patch that are intended to make abuse a very unpleasant experience thereby deterring the recreational abuse of fentanyl patches.

aversive agents have high potency, established safety, and the potential to prevent accidental misuse by children and pets.

agents are coated onto the backing of the transdermal patch in a controlled release formulation that provides immediate and sustained

release of aversive agents.

This provides several advantages including having a physical separation of the aversive agents from the drug

matrix, availability of aversive agents even after the patch is used and making it difficult to separate the aversive agents from the

drug by extraction.

The aversive agents are not contained in the drug matrix and are not delivered to the skin during patch wear.

to the fentanyl patch, this technology has broad applicability to any patch where deterring abuse as well as accidental misuse by children

and pets are valuable attributes.

According to the FDA 1 , accidental

exposure to medication is a leading cause of poisoning in children.

Young children, in particular, have died or become seriously ill after

being exposed to a skin patch containing fentanyl, a powerful opioid pain reliever.

Children can overdose on new and used fentanyl patches

by putting them in their mouth or sticking the patches on their skin.

This can cause death by slowing the child’s breathing and decreasing

the levels of oxygen in their blood.

We believe that our abuse deterrent technology

can be broadly applied to various transdermal products and our strategy is to follow the development of our AVERSA Fentanyl with the development

of additional products for pharmaceuticals that have a risk or history of abuse, misuse or accidental exposure.

For example, we believe

that our technology can be utilized in other transdermal products to deter the abuse of other drugs such as buprenorphine, an opioid,

and methylphenidate, a central nervous system stimulant.

Buprenorphine is an opioid used to treat opioid addiction, acute pain and chronic

8 unchanged sentences

systems for buprenorphine and methylphenidate after we make significant progress on our abuse deterrent fentanyl transdermal system.

Our research pipeline consists primarily of drug compounds which have

been previously approved by the FDA and are now off-patent.

In some cases, we are developing a non-injectable version of the drug utilizing

our transdermal technology which represents a new route of administration.

In most cases, we plan to utilize the 505(b) (2) NDA regulatory

pathway provided by the FDA which allows us to reference the safety information on file at FDA for the approved drug or to reference the

published literature instead of having to generate new safety information that would typically be required for new chemical entities.

However, we cannot assure you that the FDA will concur with our approach or that we will be able to receive FDA approval to market any

of products that we develop.

We are also exploring transdermal delivery of proteins and peptides

such as exenatide for type 2 diabetes and follicle stimulating hormone (FSH) for infertility.

Presently, these products are only available

by injection.

We believe that transdermal delivery has the potential to improve compliance, which can lead to improved therapeutic outcomes

associated with these treatments.

In addition, we may seek to develop certain generic transdermal products

where we think we can efficiently make an improvement to existing patches and potentially take significant market share with good profit

The prioritization of our portfolio of product candidates will be reviewed

on an ongoing basis and will take into account technical progress, market potential, available funding and commercial interest.

to take any meaningful steps to the development of any of these products is determined by our ability to provide sufficient funding for

such activities.

As stated above, without additional financing or a joint venture agreement we will not be able to take any steps to the

development of any of these products.

We currently have no branded OTC or consumer products nor do we plan

to launch any OTC or consumer products in the near term as our focus is primarily on our pharmaceutical development pipeline and continuing

the contract services offered by our subsidiaries.

Our research pipeline consists primarily of drug

compounds which have been previously approved by the FDA and are now off-patent.

In some cases, we are developing a non-injectable version

of the drug utilizing our transdermal technology which represents a new route of administration.

We believe that transdermal delivery

has the potential to improve compliance, which can lead to improved therapeutic outcomes associated with these treatments.

In most cases,

we plan to utilize the 505(b) (2) NDA regulatory pathway provided by the FDA which allows us to reference the safety information

on file at FDA for the approved drug or to reference the published literature instead of having to generate new safety information that

would typically be required for new chemical entities.

However, we cannot assure you that the FDA will concur with our approach or that

we will be able to receive FDA approval to market any of products that we develop.

In addition, we may seek to develop certain generic

transdermal products where we think we can efficiently make an improvement to existing patches and potentially take significant market

share with good profit margins.

The prioritization of our portfolio of product

candidates will be reviewed on an ongoing basis and will take into account technical progress, market potential, available funding and

commercial interest.

Our ability to take any meaningful steps to the development of any of these products is determined by our ability

to provide sufficient funding for such activities.

Pharmaceutical Manufacturing and Supply

Manufacturing of our pharmaceutical transdermal products in development

will be performed in compliance with FDA current Good Manufacturing Practices (cGMP) and all applicable local regulations by contract

manufacturers.

All manufacturing processes and facilities will be subject to review by the FDA during development, prior to approval and

during subsequent routine FDA inspections.

We plan to continue to rely on contract manufacturers and, potentially, collaboration partners

to manufacture commercial quantities of our products, if and when approved for marketing by the FDA.

Government Regulation

Manufacturing of our pharmaceutical transdermal

products in development will be performed in compliance with FDA current Good Manufacturing Practices (cGMP) and all applicable local

regulations by contract manufacturers.

All manufacturing processes and facilities will be subject to review by the FDA during development,

prior to approval and during subsequent routine FDA inspections.

We plan to continue to rely on contract manufacturers and, potentially,

collaboration partners to manufacture commercial quantities of our products, if and when approved for marketing by the FDA.

1 https://www.fda.gov/consumers/consumer-updates/accidental-exposures-fentanyl-patches-continue-be-deadly-children

Government Regulation and Regulatory Path

United States

The pharmaceutical business is subject to extensive government regulation.

The pharmaceutical business is subject to extensive

government regulation.

In the United States, we must comply with the rules and regulations of the FDA.

In other countries, we must comply with the laws and regulations

of each country to legally market and sell our products.

Obtaining FDA approval does not mean that the product will be approved in other

In other countries, we must comply

with the laws and regulations of each country to legally market and sell our products.

Obtaining FDA approval does not mean that the product

will be approved in other countries.

Each country may require that additional clinical and nonclinical studies be conducted prior to approval.

The process required by the FDA to receive approval prior to marketing

and distributing a drug in the United States generally involves a preclinical phase followed by three phases of clinical trials.

The definition

of drug is broadly defined and includes the pharmaceutical products we have in development.

Even though the drug used in each of our proposed

products is currently approved by the FDA in other dosage forms, we will still need to conduct a development program that will include

preclinical and clinical trials before we receive FDA marketing approval.

The FDA also has a number of abbreviated approval pathways which,

if we are eligible, could shorten the time for approval.

For example, the regulatory path for the AVERSA products in development is intended

to follow a 505(b)(2) NDA regulatory pathway which reduces the amount of clinical work that needs to be performed to a single trial to

evaluate the abuse potential of the product as the safety and efficacy of the drug has already been established.

However, we cannot be

certain that we will be able to use any abbreviated approval pathway, in which event we will need to comply with the full regulatory pathway

as described below.

The full (although not typical for the AVERSA related products) FDA

regulatory pathway consists of the following phases of development.

The process required by the FDA to receive approval

prior to marketing and distributing a drug in the United States generally involves a preclinical phase followed by three phases of clinical

The definition of drug is broadly defined and includes the pharmaceutical products we have in development.

Even though the drug

used in each of our proposed products is currently approved by the FDA in other dosage forms, we will still need to conduct a development

program that will include preclinical and clinical trials before we receive FDA marketing approval.

The FDA also has a number of abbreviated

approval pathways which, if we are eligible, could shorten the time for approval.

For example, the regulatory path for the AVERSA products

in development is intended to follow a 505(b)(2) NDA regulatory pathway which may reduce the amount of clinical work that needs to be

performed to a single trial to evaluate the abuse potential of the product as the safety and efficacy of the drug has already been established.

However, we cannot be certain that we will be able to use any abbreviated approval pathway, in which event we will need to comply with

the full regulatory pathway as described below.

In general, the full NDA product development program

required for new drugs for FDA approval consists of the following phases of development listed below.

The full NDA pathway is not expected

to be required for products incorporating AVERSA technology into an already approved transdermal patch.

Preclinical phase .

23 unchanged sentences

The application includes trial data, preclinical information and details on the drug’s manufacturing process.

If the FDA accepts the application for review, the agency has ten months — or six months if the drug has priority review status — to make a decision, according to the report.

If the FDA accepts the application for review, the agency typically has ten months, or six months if the drug has priority review status, to make a decision whether to approve the drug or not.

The FDA can hold an advisory committee meeting where independent experts assess the data and recommend whether to approve the drug.

From there, the FDA will either approve the drug or give the applicant a complete response letter, which explains why the drug did not get approved and what steps the applicant must take before resubmitting the application for approval.

Before approving an NDA, the FDA may inspect the facilities where the

product is being manufactured or facilities that are significantly involved in the product development and distribution process and will

not approve the product unless they determine that compliance with current good manufacturing practices is satisfactory.

The FDA may deny

approval of an NDA if applicable statutory or regulatory criteria are not satisfied, or may require additional testing or information,

which can delay the approval process.

In pursuing FDA approval there may be various delays and it is possible that approval may never

In addition, new government requirements may be established that could delay or prevent regulatory approval of our product

candidates under development.

If a product is approved, the FDA may impose limitations on the indications

for use for which the product may be marketed, may require that warning statements be included in the product labeling, may require that

additional studies or trials be conducted following approval as a condition of the approval, may impose restrictions and conditions on

product distribution, prescribing or dispensing in the form of a risk management plan, or impose other limitations.

Once a product receives FDA approval, marketing the product for other

indicated uses or making certain manufacturing or other changes related to the product will require FDA review and approval of a supplemental

NDA or a new NDA, which may require additional clinical safety and efficacy data and may require additional review fees.

further post-marketing testing and surveillance to monitor the safety or efficacy of a product may be required.

Also, product approvals

may be withdrawn if compliance with regulatory standards is not maintained or if safety or manufacturing problems occur following initial

With respect to the labeling for our abuse deterrent transdermal fentanyl

system or any other opioid transdermal patch we develop, it is likely that we will need to disclose the risks of improper use or abuse

using language required by the FDA.

Before approving an NDA, the FDA may inspect the

facilities where the product is being manufactured or facilities that are significantly involved in the product development and distribution

process and will not approve the product unless they determine that compliance with current good manufacturing practices is satisfactory.

The FDA may deny approval of an NDA if applicable statutory or regulatory criteria are not satisfied, or may require additional testing

or information, which can delay the approval process.

In pursuing FDA approval there may be various delays and it is possible that approval

may never be granted.

In addition, new government requirements may be established that could delay or prevent regulatory approval of our

product candidates under development.

If a product is approved, the FDA may impose limitations

on the indications for use for which the product may be marketed, may require that warning statements be included in the product labeling,

may require that additional studies or trials be conducted following approval as a condition of the approval, may impose restrictions

and conditions on product distribution, prescribing or dispensing in the form of a risk management plan, or impose other limitations.

Once a product receives FDA approval, marketing

the product for other indicated uses or making certain manufacturing or other changes related to the product will require FDA review and

approval of a supplemental NDA or a new NDA, which may require additional clinical safety and efficacy data and may require additional

In addition, further post-marketing testing and surveillance to monitor the safety or efficacy of a product may be required.

Also, product approvals may be withdrawn if compliance with regulatory standards is not maintained or if safety or manufacturing problems

occur following initial marketing.

With respect to the labeling for our abuse deterrent

transdermal fentanyl system or any other opioid transdermal patch we develop, it is likely that the FDA will require us to disclose the

risks of improper use or abuse using language required by the FDA upon approval.

FDA Approval Pathways

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This is typically the pathway used for new chemical entities.

A 505(b)(2) application is an NDA submitted under Section 505(b)(1) and approved under Section 505(c) of the FD&C Act that contains full reports of investigations of safety and effectiveness, where at least some of the information required for approval comes from studies not conducted by or for the applicant and for which the applicant has not obtained a right of reference or use.

A 505(b)(2) application is a limited NDA submitted under Section 505(b)(1) and approved under Section 505(c) of the FD&C Act that contains full reports of investigations of safety and effectiveness, where at least some of the information required for approval comes from studies not conducted by or for the applicant and for which the applicant has not obtained a right of reference or use.

This is the pathway typically taken for off-patent drugs that are being development into alternate dosage forms or routes of administration.

4 unchanged sentences

This is the pathway taken for generic drugs.

We cannot assure you that we will be able to take advantage of any

of the available abbreviated approval pathways for any of our proposed products.

Nutriband plans to utilize the 505(b)(2) New Drug

Application (NDA) regulatory pathway which limits the development required for products that contain drugs that have already been approved,

and allows applicants to reference data already on file at the FDA.

As a result, the NDA application will be primarily based on a single

Phase 1 human abuse potential clinical study with no Phase 2 or 3 clinical trials needed.

A clinical abuse potential study is typically

performed in recreational drug abusers and is designed to demonstrate that the abuse-deterrent product is less preferable to recreational

drug abusers than conventional fentanyl patches which contain no abuse-deterrent technology.

Following a successful Phase 1 clinical abuse

potential study, Nutriband intends to file a 505(b)(2) NDA to the FDA for marketing approval of AVERSA™ Fentanyl, which has the

potential to be the first and only abuse deterrent patch approved anywhere in the world.

The AVERSA™ Fentanyl NDA has the potential

to receive an expedited review by FDA as has been granted for certain abuse-deterrent oral opioid products, which shortens the regulatory

review period to six months from the conventional 10-month FDA review cycle for NDAs.

Combined, the clinical development and regulatory

path for AVERSA Fentanyl is substantially limited compared to conventional pharmaceutical product development, requiring only a single

clinical trial and, following a limited NDA pathway, undergoing an expedited review by the FDA.

We cannot assure you that we will be able to take

advantage of any of the available abbreviated approval pathways for any of our proposed products.

Post-approval requirements

Any drug products for which we receive FDA approval will be subject

to continuing regulation by the FDA.

Certain requirements include, among other things, record-keeping requirements, reporting of adverse

events with the product, providing the FDA with updated safety and efficacy information on an annual basis or more frequently for specific

events, product sampling and distribution requirements, complying with certain electronic records and signature requirements and complying

with FDA promotion and advertising requirements.

These promotion and advertising requirements include, among others, standards for direct-to-consumer

advertising, prohibitions against promoting drugs for uses or patient populations that are not described in the drug’s approved

labeling, known as “off-label use,” and other promotional activities, such as those considered to be false or misleading.

Failure to comply with FDA regulations can have negative consequences, including the immediate discontinuation of noncomplying materials,

adverse publicity, enforcement letters from the FDA, mandated corrective advertising or communications with doctors, and civil or criminal

Any drug products for which we receive FDA approval

will be subject to continuing regulation by the FDA.

Certain requirements include, among other things, record-keeping requirements, reporting

of adverse events with the product, providing the FDA with updated safety and efficacy information on an annual basis or more frequently

for specific events, product sampling and distribution requirements, complying with certain electronic records and signature requirements

and complying with FDA promotion and advertising requirements.

These promotion and advertising requirements include, among others, standards

for direct-to-consumer advertising, prohibitions against promoting drugs for uses or patient populations that are not described in the

drug’s approved labeling, known as “off-label use,” and other promotional activities, such as those considered to be

false or misleading.

Failure to comply with FDA regulations can have negative consequences, including the immediate discontinuation of

noncomplying materials, adverse publicity, enforcement letters from the FDA, mandated corrective advertising or communications with doctors,

and civil or criminal penalties.

Such enforcement may also lead to scrutiny and enforcement by other government and regulatory bodies.

Although physicians may prescribe legally available drugs for off-label

uses, manufacturers may not encourage, market or promote such off-label uses.

As a result, “off-label promotion” has formed

the basis for litigation under the Federal False Claims Act, violations of which are subject to significant civil fines and penalties.

In addition, manufacturers of prescription products are required to disclose annually to the Center for Medicaid and Medicare any payments

made to physicians and teaching hospitals in the U.S.

Although physicians may prescribe legally available

drugs for off-label uses, manufacturers may not encourage, market or promote such off-label uses.

As a result, “off-label promotion”

has formed the basis for litigation under the Federal False Claims Act, violations of which are subject to significant civil fines and

In addition, manufacturers of prescription products are required to disclose annually to the Center for Medicaid and Medicare

any payments made to physicians and teaching hospitals in the U.S.

under the federal Physician Payment Sunshine Act.

Reportable payments may be direct

or indirect, in cash or kind, for any reason, and are required to be disclosed even if the payments are not related to the approved product.

Reportable payments

may be direct or indirect, in cash or kind, for any reason, and are required to be disclosed even if the payments are not related to the

approved product.

Failure to fully disclose or not in time reporting could lead to penalties up to $1.15 million per year.

The manufacturing of any of our products will be required to comply

with the FDA’s current Good Manufacturing Practices (cGMP) regulations.

These regulations require, among other things, quality control

and quality assurance, as well as the corresponding maintenance of comprehensive records and documentation.

Drug manufacturers and other

entities involved in the manufacture and distribution of approved drugs are also required to register with the FDA their establishments

and list any products they make and to comply with related requirements in certain states.

These entities are further subject to periodic

unannounced inspections by the FDA and certain state agencies for compliance with current good manufacturing practices and other laws.

Accordingly, manufacturers must continue to expend time, money and effort in the area of production and quality control to maintain cGMP

Discovery of problems with a product after approval may result in serious

and extensive restrictions on a product, manufacturer or holder of an approved NDA, as well as lead to potential market disruptions.

restrictions may include recalls, suspension of a product until the FDA is assured that quality standards can be met, and continuing oversight

of manufacturing by the FDA under a “consent decree,” which frequently includes the imposition of costs and continuing inspections

over a period of many years, as well as possible withdrawal of the product from the market.

In addition, changes to the manufacturing

process generally require prior FDA approval before being implemented.

Other types of changes to the approved product, such as adding

new indications and additional labeling claims, are also subject to further FDA review and approval.

The FDA also may require post-marketing testing, or Phase IV testing,

as well as risk minimization action plans and surveillance to monitor the effects of an approved product or place conditions on an approval

that could otherwise restrict the distribution or use of our products.

The manufacturing of any of our products will

be required to comply with the FDA’s current Good Manufacturing Practices (cGMP) regulations.

These regulations require, among other

things, quality control and quality assurance, as well as the corresponding maintenance of comprehensive records and documentation.

manufacturers and other entities involved in the manufacture and distribution of approved drugs are also required to register with the

FDA their establishments and list any products they make and to comply with related requirements in certain states.

These entities are

further subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with current good manufacturing

practices and other laws.

Accordingly, manufacturers must continue to expend time, money and effort in the area of production and quality

control to maintain cGMP compliance.

Discovery of problems with a product after approval

may result in serious and extensive restrictions on a product, manufacturer or holder of an approved NDA, as well as lead to potential

market disruptions.

These restrictions may include recalls, suspension of a product until the FDA is assured that quality standards can

be met, and continuing oversight of manufacturing by the FDA under a “consent decree,” which frequently includes the imposition

of costs and continuing inspections over a period of many years, as well as possible withdrawal of the product from the market.

changes to the manufacturing process generally require prior FDA approval before being implemented.

Other types of changes to the approved

product, such as adding new indications and additional labeling claims, are also subject to further FDA review and approval.

The FDA also may require post-marketing testing,

or Phase IV testing, as well as risk minimization action plans and surveillance to monitor the effects of an approved product or place

conditions on an approval that could otherwise restrict the distribution or use of our products.

Other Government Regulations

We may be subject to government regulations that are applicable to

businesses generally, including those relating to workers’ health and safety, environmental and waste disposal, wage and hour and

labor practices, including sexual harassment laws and regulations, and anti-discrimination laws and regulations.

In addition, we must comply with the laws and regulations governing

the research and manufacture of products containing controlled substances such as fentanyl and other opioids.

We or our contract manufacturer

must be licensed by the Drug Enforcement Agency (DEA) and the state(s) in which we conduct research and development activities.

We may be subject to government regulations that

are applicable to businesses generally, including those relating to workers’ health and safety, environmental and waste disposal,

wage and hour and labor practices, including sexual harassment laws and regulations, and anti-discrimination laws and regulations.

In addition, we must comply with the laws and

regulations governing the research and manufacture of products containing controlled substances such as fentanyl and other opioids.

or our contract manufacturer must be licensed by the Drug Enforcement Agency (DEA) and the state(s) in which we conduct research and development

Europe and Other Countries

If we market our products in any countries other than the United States,

we would be subject to the laws of those countries.

To obtain market access for our products in other countries we must comply with numerous

and varying regulatory requirements of such countries regarding safety and efficacy and governing, among other things, clinical trials

and commercial sales, pricing and distribution of our products.

The European medicines regulatory system is based on a network of around

50 regulatory authorities from the 31 countries in the European Economic Area, the European Commission and the European Medicines

If we market our products in any countries other

than the United States, we would be subject to the laws of those countries.

To obtain market access for our products in other countries

we must comply with numerous and varying regulatory requirements of such countries regarding the demonstration of safety and efficacy

for authorization and governing, among other things, clinical trials and commercial sales, pricing and distribution of our products.

The European medicines regulatory system is based

on a network of around 50 regulatory authorities from the 31 countries in the European Economic Area, the European Commission and

the European Medicines Agency.

All medicines must be authorized before they can be placed on the market in the European Union.

The European system offers different

routes for authorization.

A centralized procedure allows the marketing of a medicine on the basis of a single European Union assessment

and marketing authorization which is valid throughout the European Union.

However, a majority of medicines authorized in the European

Union do not fall within the scope of the centralized procedure, and we do not know whether our proposed products will fall within the

centralized authorization.

We also do not know how the withdrawal of Great Britain from the European Union will affect the procedure for

approval of medicines in the United Kingdom.

If we are not able to use the centralized procedure, we would need to use one of the following

One method is the decentralized procedure where we would apply for simultaneous authorization in more than one European Union

The second method is the mutual-recognition procedure where we would have a medicine authorized in one European Union country

apply for authorization to be recognized in other European Union countries.

In either case, we would be required to complete clinical

trials to demonstrate the safety and efficacy of the medicine and show that the medicine is manufactured in accordance with good manufacturing

practices based upon European Union standards.

In countries other than the United States and the European Union, we

would be required to comply with the applicable laws of those countries, which may require us to perform additional clinical testing.

Failure to obtain regulatory approval in any country would prevent

our product candidates from being marketed in those countries.

In order to market and sell our products in jurisdictions other than the

United States and the European Union, we must obtain separate marketing approvals and comply with numerous and varying regulatory requirements.

The regulatory approval process outside the United States and the European Union generally includes all of the risks associated with obtaining

FDA and European Union approval but can involve additional testing.

In addition, in many countries worldwide, it is required that the product

be approved for reimbursement before the product can be approved for sale in that country.

We may not obtain approvals from regulatory

authorities outside the United States on a timely basis, if at all.

Even if we were to receive approval in the United States or the European

Union, approval by the FDA or the European Medicines Agency does not ensure approval by regulatory authorities in other countries or jurisdictions.

Similarly, approval by one regulatory authority outside the United States would not ensure approval by regulatory authorities in other

countries or jurisdictions.

We may not be able to file for marketing approvals and may not receive necessary approvals to commercialize

our products in any market.

If we are unable to obtain approval of our product candidates by regulatory authorities in other foreign jurisdictions,

the commercial prospects of those product candidates may be significantly diminished and our business prospects could decline.

Outside the United States, particularly in member states of the European

Union, the pricing of prescription drugs is subject to governmental control.

In these countries, pricing negotiations or the successful

completion of health technology assessment procedures with governmental authorities can take considerable time after receipt of marketing

approval for a product.

In addition, there can be considerable pressure by governments and other stakeholders on prices and reimbursement

levels, including as part of cost containment measures.

In addition to regulations in the United States, if we market outside

of the United States, we will be subject to a variety of regulations governing, among other things, clinical trials and any commercial

sales and distribution of our products.

Whether or not we obtain FDA approval for a product, we must obtain the requisite approvals from

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

system offers different routes for authorization.

A centralized procedure allows the marketing of a medicine on the basis of a single

European Union assessment and marketing authorization which is valid throughout the European Union.

However, a majority of medicines authorized

in the European Union do not fall within the scope of the centralized procedure, and we do not know whether our proposed products will

fall within the centralized authorization.

We also do not know how the withdrawal of Great Britain from the European Union will affect

the procedure for approval of medicines in the United Kingdom.

If we are not able to use the centralized procedure, we would need to use

one of the following procedures.

One method is the decentralized procedure where we would apply for simultaneous authorization in more

than one European Union member.

The second method is the mutual-recognition procedure where we would have a medicine authorized in one

European Union country apply for authorization to be recognized in other European Union countries.

In either case, we would be required

to complete clinical trials to demonstrate the safety and efficacy of the medicine and show that the medicine is manufactured in accordance

with good manufacturing practices based upon European Union standards.

In countries other than the United States and

the European Union, we would be required to comply with the applicable laws of those countries, which may require us to perform additional

clinical testing.

Failure to obtain regulatory approval in any country

would prevent our product candidates from being marketed in those countries.

In order to market and sell our products in jurisdictions

other than the United States and the European Union, we must obtain separate marketing approvals and comply with numerous and varying

regulatory requirements.

The regulatory approval process outside the United States and the European Union generally includes all of the

risks associated with obtaining FDA and European Union approval but can involve additional testing.

In addition, in many countries worldwide, it is

required that the product be approved for reimbursement before the product can be approved for sale in that country.

We may not obtain

approvals from regulatory authorities outside the United States on a timely basis, if at all.

Even if we were to receive approval in the

United States or the European Union, approval by the FDA or the European Medicines Agency does not ensure approval by regulatory authorities

in other countries or jurisdictions.

Similarly, approval by one regulatory authority outside the United States would not ensure approval

by regulatory authorities in other countries or jurisdictions.

We may not be able to file for marketing approvals and may not receive

necessary approvals to commercialize our products in any market.

If we are unable to obtain approval of our product candidates by regulatory

authorities in other foreign jurisdictions, the commercial prospects of those product candidates may be significantly diminished and our

business prospects could decline.

Outside the United States, particularly in member

states of the European Union, the pricing of prescription drugs is subject to governmental control.

In these countries, pricing negotiations

or the successful completion of health technology assessment procedures with governmental authorities can take considerable time after

receipt of marketing approval for a product.

In addition, there can be considerable pressure by governments and other stakeholders on

prices and reimbursement levels, including as part of cost containment measures.

In addition to regulations in the United States,

if we market outside of the United States, we will be subject to a variety of regulations governing, among other things, clinical trials

and any commercial sales and distribution of our products.

Whether or not we obtain FDA approval for a product, we must obtain the requisite

approvals from regulatory authorities in foreign countries prior to the commencement of clinical trials or marketing of the product in

those countries.

Intellectual Property

The AVERSA abuse deterrent technology utilized in our AVERSA product

pipeline is covered by an international intellectual property portfolio with patents issued in 45 countries including the United States,

Europe, Japan, Korea, Russia, Mexico, Canada, and Australia and pending in China.

These patents provide patent coverage to 2035.

to build on our proprietary positions in the United States and internationally for our product candidates AVERSA Fentanyl, AVERSA buprenorphine

and AVERSA methylphenidate as well as other products and technology that we may have in development.

Our policy is to pursue, maintain

and defend patent rights developed internally or acquired externally and to protect the technology, inventions and improvements that are

commercially important to the development of our business.

We cannot be sure that patents will be granted with respect to any of our pending

patent applications or with respect to any patent applications filed by us in the future, nor can we be sure that any of our existing

patents or any patents granted to us in the future will be commercially useful in protecting our technology.

We also may rely on trade

secrets to protect our commercial products and product candidates.

Our commercial success also depends in part on our non-infringement

of the patents or proprietary rights of third parties.

Further, we plan to seek trademark protection in the United States

and internationally where available and when appropriate.

The AVERSA abuse deterrent technology

utilized in our AVERSA product pipeline is covered by an international intellectual property portfolio with patents issued in 45

countries including the United States, Europe, Japan, Korea, Russia, Mexico, Canada, and Australia and pending in China and Hong Kong.

patents provide patent coverage to 2035.

We continue to build on our proprietary positions in the United States and internationally

for our product candidates AVERSA Fentanyl, AVERSA Buprenorphine and AVERSA Methylphenidate as well as other products and technology

that we may have in development.

Our policy is to pursue, maintain and defend patent rights developed internally or acquired

externally and to protect the technology, inventions and improvements that are commercially important to the development of our

We cannot be sure that patents will be granted with respect to any of our pending patent applications or with respect to

any patent applications filed by us in the future, nor can we be sure that any of our existing patents or any patents granted to us

in the future will be commercially useful in protecting our technology.

We also may rely on trade secrets to protect our commercial

products and product candidates.

Our commercial success also depends in part on our non-infringement of the patents or proprietary

rights of third parties.

On September 19, 2023, the United States Patent

and Trademark Office (USPTO) granted US Patent No.

11,759,431 for Nutriband’s proprietary AVERSA abuse deterrent technology utilizing

taste aversion to address the primary routes of abuse of opioid based transdermal patches.

The issuance of this patent, entitled, “Abuse

and Misuse Deterrent Transdermal Systems,” further expands Nutriband’s intellectual property protection in the United States for

its portfolio of AVERSA abuse deterrent transdermal products.

Further, we plan to seek trademark protection

in the United States and internationally where available and when appropriate.

We have registered the name Nutriband in the United States.

We have received

a notice of allowance for the AVERSA trademark for our abuse deterrent technology in the United States.

The pharmaceutical industry is highly competitive and subject to rapid

change as new products are developed and marketed.

Potential competitors include large pharmaceutical and biotechnology companies, specialty

pharmaceutical and generic drug companies, and medical technology companies.

We believe the key competitive factors that will affect the

development and commercial success of our products are product performance including safety and efficacy, level of patient compliance,

healthcare professional acceptance, and the extent of insurance reimbursement of our products.

As our development pipeline includes products that contain opioids

(AVERSA Fentanyl and AVERSA Buprenorphine), we continually monitor the market for opioid products, particularly in the United States.

Pharmaceutical companies engaged in the distribution and sale of opioids, in particular for the treatment of chronic pain, are promoting

responsible opioid use.

In 2022, the CDC revised its clinical practice guideline for prescribing opioids to ease the restrictions on prescribers

and encourage responsible opioid use particularly for patients with moderate to severe pain.

Our opioid products potentially offer a unique

proposition to meet the unmet needs of patients by deterring the abuse and misuse of opioids while making opioids accessible to those

patients who need them.

If approved, our AVERSA pipeline products will compete with the currently marketed products that do not contain

abuse deterrent features as well as other products that may employ different abuse deterrent technology.

We may also have to compete with

products that do not contain opioids or other drugs that are susceptible to abuse.

We are not aware of any abuse deterrent transdermal

products that are in development or being marketed at this time.

If we obtain regulatory approval to market our products, we cannot assure

you that we will be successful in the marketplace.

We have filed an intent to use Trademark application for AVERSA.

The USPTO will require us to show the mark used in commerce prior

to fully registering the trademark.

On March 8, 2024, Nutriband presented data on

the incidence of transdermal patch abuse and accidental pediatric exposure as a scientific poster at the 2024 American Academy of Pain

Medicine (AAPM) Annual Meeting 2 .

The American Academy of Pain Medicine (AAPM) is dedicated to advancing multidisciplinary

pain care, education, advocacy, and research.

The company engaged Rocky Mountain Poison &

Drug Safety (RMPDS), a division of Denver Health and Hospital Authority, Denver, Colorado, to determine the incidence of abuse and accidental

pediatric exposure of transdermal patches containing drugs of abuse (fentanyl, buprenorphine, and methylphenidate) in the United States

based on poison center data for the surveillance period 2018-2022.

RMPDS utilized the Researched Abuse, Diversion and Addiction-Related

Surveillance (RADARS®) System, a surveillance system that collects real-world safety and effectiveness data about prescription drugs

(https://www.radars.org/).

The data indicate that transdermal patch abuse

and accidental pediatric exposures to patches continues to be a serious problem resulting in major medical outcomes and death, suggesting

an unmet need for safer abuse-deterrent versions of transdermal patches containing drugs with a risk of abuse, misuse or accidental exposure.

Key findings from the study showed that major medical outcome or death resulted from a notable proportion of fentanyl and buprenorphine

patch intentional and accidental pediatric exposures with two deaths reported due to abuse of fentanyl transdermal patches.

The oral route

accounted for the majority of fentanyl patch abuse with 62.5% of all intentional abuse/misuse event reports for fentanyl patches (85.3%

of non-dermal routes of abuse).

Furthermore, there was a notable proportion of accidental pediatric exposures to transdermal formulations

that resulted in major medical outcomes (fentanyl patches:

10.1%, buprenorphine patches:

Abuse and overdose are a real problem

with transdermal fentanyl as well as other transdermal opioid and stimulant products.

In addition, there continues to be an alarming amount

of accidental pediatric exposures, resulting in major negative health outcomes.

We believe our AVERSA abuse-deterrent technology will

have a substantial impact on both of these unfortunate and preventable situations and will help reduce the risk of harm from opioid and

stimulant patches by providing taste aversion agents in every patch.

Market Assessment

The company engaged leading healthcare consulting company Health Advances

to assess the market opportunity and commercial strategy for AVERSA Fentanyl and AVERSA Buprenorphine.

AVERSA Fentanyl is the lead AVERSA product under development and has

the potential to be the world’s first fentanyl transdermal systems with abuse deterrent properties.

Once approved by the United States

FDA, Aversa Fentanyl will be priced competitively with the non-abuse deterrent patch and has the potential to reach peak annual US sales

of $80-200 million according to the assessment performed by Health Advances in January 2022.

This assessment did not include the impact

of the revised CDC Opioid Prescribing Guidelines which were published in November 2022 that encouraged prescribers to implement comprehensive

and holistic pain management including responsible opioid use particularly for patients with moderate to severe chronic pain.

Health Advances

was able to confirm the significant unmet patient need for AVERSA Fentanyl based on rigorous primary and secondary market research accompanied

with deep experience in the abuse deterrence pain space.

Nutriband is also considering developing the product for strategic international

markets as protected by its global abuse deterrent patent portfolio.

2 Olsen, H, Mogusu, E, Black, JC, Sumbundu, K, Dart, RC.

Poison center exposure calls involving

fentanyl, buprenorphine, and methylphenidate transdermal patches in the United States.

Poster presented at the 40th Annual Meeting

of the American Academy of Pain Medicine;

2024 Mar 7-10;

Scottsdale, Arizona.

https://www.radars.org/system/publications/39.%20Olsen.pdf

AVERSA Buprenorphine is the second AVERSA product under development

and has the potential to be the world’s first buprenorphine transdermal systems with abuse deterrent properties.

Once approved by the

United States FDA, Aversa Buprenorphine will be priced competitively with non-abuse deterrent options and has the potential to reach peak

annual US sales of $70-130 million according to the assessment performed by Health Advances in October 2023.

Health Advances was able

to confirm the significant unmet patient need for Aversa™ Buprenorphine based on rigorous primary and secondary market research

accompanied with deep experience in the abuse deterrence pain space.

Nutriband is also considering developing the product for strategic

international markets as protected by its global abuse deterrent patent portfolio.

The pharmaceutical industry is highly competitive

and subject to rapid change as new products are developed and marketed.

Potential competitors include large pharmaceutical and biotechnology

companies, specialty pharmaceutical and generic drug companies, and medical technology companies.

We believe the key competitive factors

that will affect the development and commercial success of our products are product performance including safety and efficacy, level of

patient compliance, healthcare professional acceptance, and the extent of insurance reimbursement of our products.

As our development pipeline includes products

that contain opioids (AVERSA Fentanyl and AVERSA Buprenorphine), we continually monitor the market for opioid products, particularly in

the United States.

Pharmaceutical companies engaged in the distribution and sale of opioids, in particular for the treatment of chronic

pain, are promoting responsible opioid use.

In 2022, the CDC revised its clinical practice guideline for prescribing opioids to ease the

restrictions on prescribers and encourage responsible opioid use particularly for patients with moderate to severe pain.

Our abuse deterrent

opioid products potentially offer a unique proposition to meet the unmet needs of patients by deterring the abuse and misuse of opioids

while making opioids accessible to those patients who need them.

If approved, our AVERSA pipeline products will compete with the currently

marketed products that do not contain abuse deterrent features as well as other products that may employ different abuse deterrent technology.

We may also have to compete with products that do not contain opioids or other drugs that are susceptible to abuse.

We are not aware of

any abuse deterrent transdermal products that are in development or being marketed at this time.

If we obtain regulatory approval to market

our products, we cannot assure you that we will be successful in the marketplace.

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