What changed in this filing

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Item 1A. Risk Factors

2023-04-26 compared with 2022-04-29 · 139 added, 154 removed, 699 unchanged (30% of the section changed)

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You should carefully consider the risks described An investment in our common stock involves a high degree of risk.

You should carefully consider the risks described below together with all of the other information included in this prospectus before

making an investment decision with regard to our securities.

The statements contained in this prospectus include forward-looking statements

that are subject to risks and uncertainties that could cause actual results to differ materially from those set forth in or implied by

forward-looking statements.

You should carefully consider the risks described below together with all of the other information included in this report before making

an investment decision with regard to our securities.

The statements contained in this report include forward-looking statements that

are subject to risks and uncertainties that could cause actual results to differ materially from those set forth in or implied by forward-looking

The risks set forth below are not the only risks facing us.

Additional risks and uncertainties may exist that

could also adversely affect our business, prospects or operations.

If any of the following risks actually occurs, our business, financial

condition or results of operations could be harmed.

In that case, the trading price of our common stock could decline, and you may lose

all or a significant part of your investment.

Additional risks and uncertainties may exist that could also adversely

affect our business, prospects or operations.

If any of the following risks actually occurs, our business, financial condition or results

of operations could be harmed.

In that case, the trading price of our common stock could decline, and you may lose all or a significant

part of your investment.

Risks Concerning our Business

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you that we can or will be able to operate profitably.

During the year ended January 31, 2022, we generated revenues of $1,422,154,

a loss of $6,372,715 and a negative cash flow from operations of $2,809,223.

As of January 31, 2022, we had a working capital surplus

of $4,686,112, as compared with a working capital deficit of $2,882,794 as of January 31, 2021.

We are subject to the risks common to

start-up, pre-revenue enterprises, including, among other factors, undercapitalization, cash shortages, limitations with respect to personnel,

financial and other resources and lack of revenues.

Drug development companies typically incur substantial losses during the product development

and FDA testing phase of the business and do not generate revenues until after the drug has received FDA approval, which cannot be assured,

and until the company has started to sell the product.

We can give no assurance that we can or will ever be successful in achieving profitability

and the likelihood of our success must be considered in light of our early stage of operations.

We cannot assure you that we will be able

to operate profitably or generate positive cash flow.

If we cannot achieve profitability, we may be forced to cease operations and you

may suffer a total loss of your investment.

During the year ended January 31, 2023, we generated

revenues of $2,079,609, a loss of $4,483,474 and a negative cash flow from operations of $2,987,198.

As of January 31, 2023, we had a

working capital surplus of $1,945,132, as compared with a working capital surplus of $4,686,112 as of January 31, 2022.

We are subject

to the risks common to start-up, pre-revenue enterprises, including, among other factors, undercapitalization, cash shortages, limitations

with respect to personnel, financial and other resources and lack of revenues.

Drug development companies typically incur substantial

losses during the product development and FDA testing phase of the business and do not generate revenues until after the drug has received

FDA approval, which cannot be assured, and until the company has started to sell the product.

We can give no assurance that we can or

will ever be successful in achieving profitability and the likelihood of our success must be considered in light of our early stage of

We cannot assure you that we will be able to operate profitably or generate positive cash flow.

If we cannot achieve profitability,

we may be forced to cease operations and you may suffer a total loss of your investment.

The Russian/Belarus-Ukrainian conflict

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results of operations, and cash flows.

To date, this conflict is predicted to have a destabilizing effect on the world’s economy,

resulting in higher energy prices and inflationary pressures generally in the world’s economy, as well as possible supply chain

restraints, which will have negative effects on the world’s economy generally and to our ongoing operations specifically.

of this conflict, as well as its effects on the world economy are not known at this point.

These factors may lead to a lack of certainty

or other changes in the capital markets and limit or reduce our potential for raising the additional capital that we will require to execute

our business plan in a timely fashion.

To date, this conflict is having a destabilizing effect on the world’s economy, resulting

in higher energy prices and inflationary pressures generally in the world’s economy, as well as possible supply chain restraints,

which negatively affects the world’s economy generally and possibly our ongoing operations specifically.

The duration of this conflict,

as well as its effects on the world economy are not known at this point.

These factors may lead to a lack of certainty or other changes

in the capital markets and limit or reduce our potential for raising the additional capital that we will require to execute our business

plan in a timely fashion.

Our business will

be likely be adversely affected by the COVID-19 pandemic.

likely be adversely affected by the COVID-19 pandemic.

The COVID-19 pandemic and the response to the

pandemic will affect our business in a number of ways, including, but are not limited to, the following:

ability to raise financing for our operations and to enter into a joint venture agreement may be affected by both the willingness and

ability of potential financing sources and potential joint venture partners to invest in an undercapitalized business, particularly at

a time when the potential financing source or joint venture partner may need to devote its resources to existing portfolio companies

or joint ventures which may be in need of financing.

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.

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

Because we do not have a product we can

market in the United States, we cannot predict when or whether we will operate profitably.

pandemic could affect our business in a number of ways, including, but are not limited to, the following:

Our ability to raise financing for our operations may be affected by both the willingness and ability of potential financing sources and potential joint venture partners to invest our business.

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 decline on the willingness of investors to make an investment in our securities.

Because we do not have a product we can market

in the United States, we cannot predict when or whether we will operate profitably.

Our lead product, which is our abuse deterrent

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combinations that are considered by the FDA to be drugs, which require approval by the FDA.

In order to obtain FDA approval, it is necessary

to conduct a series of preclinical and clinical tests to confirm that the product is safe and effective.

To obtain FDA approval, it is necessary to

conduct a series of preclinical and clinical tests to confirm that the product is safe and effective.

Even though the medication that

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our preclinical and clinical trials.

Although we believe that we, through 4P

Therapeutics, have the capabilities to conduct preclinical studies and early- stage clinical studies in house, we may need to rely on

third party contract research organizations to conduct our pivotal preclinical and clinical trials.

Our failure or the failure of the

contract research organization to conduct the trials in compliance with FDA regulations could possibly derail our obtaining FDA approval

and could require us to redo any preclinical or clinical trials which we or the contract research organization administered.

We may need to rely on third party contract research

organizations to conduct our preclinical and clinical trials.

Our failure or the failure of the contract research organization to conduct

the trials in compliance with FDA regulations could possibly derail our obtaining FDA approval and could require us to redo any preclinical

or clinical trials which we or the contract research organization administered.

We may encounter delays in completing clinical

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if we receive FDA approval, our success in educating physicians and patients about the benefits, administration and use our product candidates;

our ability to raise additional capital on acceptable terms in order to achieve conduct the necessary clinical trials;

our ability to raise additional capital on acceptable terms to achieve conduct the necessary clinical trials;

the availability, perceived advantages and relative cost of alternative and competing treatments;

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may not be able to generate sufficient revenues through the sale of our products to enable us to continue our business.

Since we do not have commercial manufacturing capability, if

we are unable to establish manufacturing facilities, we may have to enter into a manufacturing agreement with a manufacturer that has

been approved by the FDA.

Any commercial manufacturer of our products and

the manufacturing facilities where we make our commercial products will be subject to FDA inspection.

Part of the process of seeking FDA

approval to market our products is the FDA’s approval of the manufacturing process and facility.

Although we may establish our own

manufacturing facilities, the establishment of a manufacturing facility is very costly, and, unless we obtain funding for that purpose,

it would be necessary for us to engage a contract manufacturer who has experience is manufacturing FDA-approved transdermal products.

By relying on a contract manufacturer, we will be dependent upon the manufacturer, whose interests may be different from ours.

manufacturer will be responsible for product quality and for meeting regulatory requirements.

If the manufacturer does not meet our quality

standards and delivers products that do not meet our specifications, we may both incur liability for breach of our warranty to our customer,

as well as liability for any adverse events, including death, that may result from the use, abuse or accidental misuse of the product.

Regardless of whether we are able to make a claim against the contract manufacturer, our reputation may be harmed and we may lose business

Further, the contract manufacturer may have other customers and may allocate its resources based on the contract manufacturer’s

interest rather than our interest.

Furthermore, we may not be able to assure ourselves that we will get favorable pricing.

If we or any third-party manufacturer fails

to comply with FDA current good manufacturing practices, we may not be able to sell our products until and unless the manufacture becomes

to comply with FDA current good manufacturing practices, we may not be able to sell our products until and unless the manufacture thereof

becomes compliant.

All FDA approved drugs, including our proposed

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Failure to be in compliance with good manufacturing practices could result in the FDA closing the facilities or limiting our use of the

If the FDA implements Risk Evaluation and

Mitigation Strategies policies for any of our proposed products, we will need to comply with such policies before we can obtain FDA approval

or the product.

If the FDA implements Risk Evaluation and Mitigation Strategies

policies for any of our proposed products, we will need to comply with such policies before we can obtain FDA approval or the product.

The Food and Drug Administration Amendments Act

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business, financial condition, result of operations and cash flows.

Before we can market our products outside

of the United States, we will need to obtain regulatory approval in each country in which we propose to sell our products.

Before we can market our products

outside of the United States, we will need to obtain regulatory approval in each country in which we propose to sell our products.

In order to market and sell our products in jurisdictions

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foreign markets for any of our products.

The drug delivery industry is subject to rapid technological

change and, our failure to keep up with technological developments may impair our ability to market our products.

The drug delivery industry is subject to

rapid technological change, and our failure to keep up with technological developments may impair our ability to market our products.

Our products use technology which we developed

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or ACA, which is popularly known as Obamacare, and the Medicare Prescription Drug Improvement and Modernization Act of 2003.

district court decision which struck down Obamacare, if upheld, could have a material adverse effect upon reimbursement and payment for

products such as our proposed products.

Changes to the healthcare system enacted as part of any healthcare reform in the United States,

as well as the increased purchasing power of entities that negotiate on behalf of Medicare, Medicaid, and private sector beneficiaries,

may result in increased pricing pressure by influencing, for instance, the reimbursement policies of third-party payors.

Regulatory changes

which have the effect of decreasing the use of opioids has resulted in a decrease in the size of the market for opioid products, including

fentanyl, could impact the market for our abuse deterrent fentanyl transdermal system or any other opioid-based transdermal product we

to the healthcare system enacted as part of any healthcare reform in the United States, as well as the increased purchasing power of entities

that negotiate on behalf of Medicare, Medicaid, and private sector beneficiaries, may result in increased pricing pressure by influencing,

for instance, the reimbursement policies of third-party payors.

Regulatory changes which have the effect of decreasing the use of opioids

has resulted in a decrease in the size of the market for opioid products, including fentanyl, could impact the market for our abuse deterrent

fentanyl transdermal system or any other opioid-based transdermal product we may develop.

It is difficult and costly to protect our

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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, and Australia.

Patent prosecution is still pending in Canada and China.

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 business.

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 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.

the United States, Europe, Japan, Korea, Russia, Mexico, Canada, and Australia.

Patent prosecution is still pending in China.

These 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 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 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.

Our ability to stop third parties from making,

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license our technology and, as noted previously, fend off competitive challenges.

Patent litigation is very expensive and we may not have

sufficient funds to defend our proprietary technology from infringement, either as a plaintiff in an action seeking to stop infringers

Patent litigation is very expensive, and we may not

have sufficient funds to defend our proprietary technology from infringement, either as a plaintiff in an action seeking to stop infringers

from using our technology, or as a defendant in an action against us alleging infringement by us.

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and we may make acquisitions in the future.

In 2017, we issued 1,250,000 shares of common stock, valued at $2,500,000, in connection with

In 2017, we issued 1,400,000 shares of common stock (adjusted for the 1-for-4 reverse stock

split effective June 23, 2019 and the 7-for-6 forward stock split effective August 15, 2022), valued at $2,500,000, in connection with

our proposed acquisition of Advanced Health Brands, Inc., but the stock of Advanced Health Brands was never transferred to us, and the

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$2,500,000 impairment loss in the year ended January 31, 2018.

In September 2018, we entered into an agreement to acquire Carmel Biosciences

Inc., and in November 2018, we terminated the agreement and are in litigation with the purported sellers of the company to us.

We previously

entered into another acquisition agreement which was rescinded shortly after the agreement was executed.

We cannot assure you that any

acquisition we complete will be successful or that any acquisition agreement we may enter into will result in an acquisition.

An acquisition

can be unsuccessful for a number of reasons, including the following:

We initiated litigation against Advance Health Brands and certain of its

stockholders, and as a result recovered all of the original Nutriband share certificates.

We previously entered into another acquisition

agreement which was rescinded shortly after the agreement was executed.

We cannot assure you that any acquisition we complete will be

successful or that any acquisition agreement we may enter into will result in an acquisition.

An acquisition can be unsuccessful for a

number of reasons, including the following:

We may incur significant expenses and devote significant management time to the acquisition, and we may be unable to consummate the acquisition on acceptable terms.

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can be impaired.

We cannot assure you that any acquisition we will make will be successful.

We may not be able to recover the 1,200,000

shares of common stock we issued in connection with our proposed acquisition of Advanced Health Brands.

On May 22, 2017, we entered into an agreement

to acquire Advanced Health Brands, which held six provisional patents for transdermal products.

Pursuant to the agreement, we were to

issue 1,250,000 shares of common stock, valued at $2,500,000, in exchange for the stock of Advanced Health Brands and a related corporation.

In August 2017, when we issued the shares to the Advanced Health Brands stockholders, the Advanced Health Brands stock had not been transferred

Although we did not have title to the shares of Advanced Health Brands stock, we treated the transaction as completed and we announced

that we had acquired Advanced Health Brands, relying on the stockholders’ obligation to transfer the shares to us.

We had appointed

two of the Advanced Health Brands stockholders as directors and executive officers.

In January 2018, we recognized an impairment loss

of $2,500,000 based on both our failure to obtain title to the Advanced Health Brands stock and our conclusion that the provisional patents

that were held by Advanced Health Brands did not have any value to us.

In December 2018 50,000 shares were returned by one of the defendants.

We have commenced legal actions against Advanced Health Brands and its stockholders in Florida and New York.

In the Florida action, the

court ruled against us.

On February 1, 2019, we appealed the court’s order.

Pursuant to a settlement agreement with one of the defendants,

that defendant returned the 50,000 shares which had been issued to her, and the shares were cancelled as of January 31, 2019.

20, 2020, the Florida district court of appeal reversed the lower court ruling in the Florida state court action that dismissed our complaint

with prejudice, and gave us leave to file an amended complaint.

The New York action was recently commenced against the stockholders of

Advanced Health Brands, and the defendants filed a motion to dismiss the action.

We cannot assure you that we will prevail in either action,

that we will be able to recover either the 1,200,000 shares of common stock or any monetary damages from the Advanced Health Brands stockholders

or that we will not incur any liability as a result of either our issuance of the shares or our failure to provide the necessary documentation

to permit the Advanced Health Brands stockholders to sell their shares pursuant to Rule 144 or from our treating and announcing the acquisition

as completed or based on other claims.

We cannot assure you that any acquisition we complete will be successful.

We are dependent on third party distributors

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Alan Smith, our chief operating officer who is president of 4P Therapeutics.

Sheridan and Mr.

Melnik have employment agreements with us, the employment agreements does not guarantee that the officer

will continue with us.

We do not have an employment agreement with Dr.

The loss of Mr.

These officers have employment agreements with us, but the employment agreements do not guarantee that the officer will continue with

The loss of any one of Mr.

Sheridan, Mr.

Melnik or Dr.

materially impair our ability to conduct our business.

Smith would materially impair our ability to conduct our business.

If we are unable to attract, train and retain

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The settlement may affect the market for and the market price of our common stock.

There are risks associated with our February

2023 dual listing of our common stock on the MERJ Upstream Exchange, which is available solely for our non-U.S.

resident stockholders.

Listing shares of the Company on Upstream is only

suitable for investors who are familiar with and willing to accept the high risk associated with speculative investments.

no assurance in that marketplace that the valuation of any particular company’s securities is accurate or in agreement with the

market or industry comparative valuations.

Investors must be able to afford market volatility and afford the loss of their investment.

Companies listed on Upstream are subject to significant ongoing corporate obligations including, but not limited to disclosure, filings,

and notification requirements, as well as compliance with applicable quantitative and qualitative listing standards.

The following are

specific risks in connection with our stockholders listing their shares on Upstream:

● Regulatory Risk :

Different countries have different

rules and regulations governing securities trading, and investors who trade on foreign exchanges may be subject to unfamiliar or complex

In some cases, foreign regulators may have different reporting requirements or different standards for disclosure than US

regulators, which can make it difficult for investors to make informed decisions.

In addition, these rules and regulations may be imposed

on regulated companies in an unpredictable manner and adversely affect the trading environment on the particular exchange.

● There are risks to the investment of our shareholders who

have listed their shares of common stock on Upstream in the event that Upstream and associated entities in its trading activities are

not properly registered with the SEC as a broker or dealer, national securities exchange and/or clearing agency.

● Market Risk :

Non-US markets may be subject to different

economic, political, or social conditions than US markets of which we are not aware, and which could negatively affect the performance

of securities traded in those markets.

Investors who trade on non-US exchanges may be exposed to higher levels of volatility and uncertainty

than they would be if they traded solely on US exchanges.

● Liquidity Risk :

Dual listed securities traded on non-US

exchanges may have lower liquidity than comparable securities traded on US exchanges, which can make it more difficult for investors

to buy or sell those securities at the desired price.

● Operational Risk :

Trading on overseas exchanges may

also expose investors to operational risks, such as delays or errors in the settlement of trades or difficulties in accessing trading

platforms or loss of securities resulting from a failure of the exchanges operating and securities transfer operations.

● Media Risk Negative news reported in the media concerning

events reported with respect to the market for our securities on a foreign exchange or international markets generally could hurt the

market for our Company’s stock.

To the extent our stockholders that choose to have their Nutriband common stock traded in digital

token form on Upstream experience trading difficulties, low trading prices due to foreign market conditions or a loss on their securities

due to market conditions or exchange operational issues, there is the risk that reports in the media could hurt our stock prices in the

Nasdaq Stock Market and harm our reputation, adversely affecting our ability to raise capital in the U.S.

and international markets.

The market price for our common stock may

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Stockholders may experience significant

dilution as a result of future equity offerings and other issuances of our common stock or other securities.

dilution from future equity offerings and other issuances of our common stock or other securities.

We will need to raise substantial funds in order

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stock and do not intend to pay cash dividends on our common stock in the foreseeable future.

UNRESOLVED STAFF COMMENTS.

Not applicable.

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 1A. Risk Factors