What changed in this filing

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Item 1A. Risk Factors

2024-05-31 compared with 2023-12-13 · 91 added, 67 removed, 54 unchanged (75% of the section changed)

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described below together with all of the other information included in this report and our Annual Report on Form 10-K, filed with the

Securities and Exchange Commission on April 26, 2023, before making an investment decision with regard to our securities.

The risks set

forth below and in our Form 10-K 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.

Securities and Exchange Commission on May 1, 2024, before making an investment decision with regard to our securities.

The risks set forth

below and in our Form 10-K 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.

Because we are an early-stage company with

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for the foreseeable future.

We face litigation risks in a legal proceeding

that could have an adverse effect on our company.

On September 21, 2023, we were sued by Joseph

Gunnar, LLC, an investment broker-dealer located in New York City (“Gunnar”), in the Supreme Court of the State of New York,

County of New York, Commercial Division, claiming damages resulting from the Company’s termination in July 2023 of an engagement

letter for our use of Gunnar as an underwriter of a public offering of our common stock.

The complaint filed by Gunnar includes claims

for damages based on, inter alia, br each of contract, misrepresentations, inducement and fraud in connection with the termination

of the proposed offering by us.

Our Chief Executive Officer and our President are both named as individual defendants in this case (see

the more detailed description of this case in Item 1.

Legal Proceedings above in this report).

The Company has filed a counterclaim against

Gunnar for breach of contract and further claims for misrepresentations, inducement and fraud related to our termination of the engagement

and Gunnar has filed an Answer to our Counterclaims.

Litigation may be time-consuming, expensive and disruptive to normal business

operations, and the outcome of this litigation is difficult to predict.

The defense of this lawsuit may result in significant expense

and a diversion of management’s time and attention from the operation of our business, which could impede our ability to achieve

our business objectives, and an unfavorable outcome may have an adverse effect on our business, financial condition and results of operations.

Additionally, any amount that we may be required to pay to satisfy a judgment or settlement of this litigation may not be covered by insurance.

Under our By-Laws and the indemnification agreements that we have entered into with our officers and directors, we are required to indemnify

and advance expenses to them in connection with their participation in proceedings arising out of their service to us.

The outcome of

litigation is inherently uncertain.

If one or more legal matters in this litigation were resolved against the Company in a reporting period

for amounts above management’s expectations, the Company’s financial condition and operating results for that reporting period

could be materially adversely affected.

Our stock price has been and is likely

to continue to be volatile and you may not be able to resell shares of our common stock at or above the price you paid, if at all.

The trading price of our common stock has

experienced fluctuations due to the factors discussed in these risk factors section and elsewhere in this report.

In addition, the stock

market in general has, and the NASDAQ Global Market and technology companies in particular have, experienced extreme price and volume

fluctuations.

our potential products are approved for marketing but fail to achieve the broad degree of physician or market acceptance necessary for

commercial success, our operating results and financial condition will be adversely affected.

If any of the products

in our pipeline receives FDA approval thereby allowing us to market the product in the United States, it will be necessary for us to generate

acceptance of our product for the indications covered by the FDA approval.

In order to generate acceptance in the marketplace, we will

need to demonstrate to physicians, patients and payors that our product provides a distinct advantage or better outcome at a price that

reflects the value of our product as compared with existing products.

We will need to develop and implement a marketing program directed

at both physicians and the general public.

Since we do not presently have the resources necessary to develop or implement an in-house

marketing program and we may not have the funds to do so if and when we obtain FDA approval to market our product, we will need to establish

a distribution network though license and distribution agreements with third parties who have the capability to market our product to

physicians, and we will be dependent upon the ability of these third parties to market our products effectively.

We cannot assure you

that we will be able to negotiate license and distribution agreements with terms that are acceptable to us.

Since we do not have an established

track record and our product pipeline is relatively small, we may be at a disadvantage in negotiating the terms of license and distribution

Further, we may have little control over the development and implementation of our licensee’s marketing program, and

our licensees may have interests that are inconsistent with ours with respect to the allocation of resources and implementation of the

marketing program.

We cannot assure you that a marketing program for any of our products can or will be implemented effectively or that

we will be successful in developing physician and emergency service acceptance 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.

Our products use technology

which we developed for the transdermal delivery of drugs.

The field of drug delivery is subject to rapid technological changes.

success will depend upon our ability to keep abreast of the latest developments in the industry and to keep pace with advances in technology

and changing customer requirements.

If we cannot keep pace with such changes and advances, our proposed products could be rendered obsolete,

which would result in our having to cease its operations.

If we obtain FDA

approval, we will face significant competition from better known and better capitalized companies.

If we obtain FDA approval

for any of our products, we expect to face significant competition from existing companies, which are better known and already have developed

relationships with physicians within the healthcare system.

Any product we may develop will compete with existing medications performing

the same medicinal functions, which may include transdermal patches.

We cannot assure you that we will be able to compete successfully.

In addition, even if we are able to commercialize our product candidates, we may not be able to price them competitively with current

standard of care products or their price may drop considerably due to factors outside our control.

If this happens or the price of materials

and manufacture increases dramatically, our ability to continue to operate our business would be materially harmed and we may be unable

to commercialize any products successfully.

In addition, other pharmaceutical companies may be engaged in developing, patenting, manufacturing

and marketing products that compete with those that we are developing.

These potential competitors may include large and experienced companies

that enjoy significant competitive advantages over us, such as greater financial, research and development, manufacturing, personnel and

marketing resources, greater brand recognition and more experience and expertise in obtaining marketing approvals from the FDA and foreign

regulatory authorities.

Our stock price has

been and is likely to continue to be volatile and you may not be able to resell shares of our common stock at or above the price you paid,

The trading price of

our common stock has experienced fluctuations due to the factors discussed in these risk factors section and elsewhere in this report.

In addition, the stock market in general has, and the NASDAQ Global Market and technology companies in particular have, experienced extreme

price and volume fluctuations.

These trading prices and valuations may not be sustainable.

These broad market and industry factors may decrease the market

price of our common stock, regardless of our actual operating performance.

In addition, in the past, following periods of volatility in

the overall market and the market price of a company’s securities, securities class action litigation has often been instituted

against companies (primarily those that are larger than us) that experienced such volatility.

This type of litigation, if instituted against

us, regardless of its outcome, could result in substantial costs and a diversion of our management’s attention and resources.

These broad market and industry factors may

decrease the market price of our common stock, regardless of our actual operating performance.

In addition, in the past, following periods

of volatility in the overall market and the market price of a company’s securities, securities class action litigation has often

been instituted against companies (primarily those that are larger than us) that experienced such volatility.

This type of litigation,

if instituted against us, regardless of its outcome, could result in substantial costs and a diversion of our management’s attention

and resources.

Our business is impacted by the following additional

Our business could be adversely affected by the effects of health pandemics or epidemics, including the recent outbreak of COVID-19, which was declared by the World Health Organization as a global pandemic, and is resulting in travel and other restrictions to reduce the spread of the disease, including state and local orders across the country, which, among other things, direct individuals to shelter at their places of residence, direct businesses and governmental agencies to cease non-essential operations at physical locations, prohibit certain non-essential gatherings, and order cessation of non-essential travel.

The effects of these orders, government-imposed quarantines and measures we would take, such as work-from-home policies, may negatively impact productivity, disrupt our business and could delay our clinical programs and timelines, the magnitude of which will depend, in part, on the length and severity of the restrictions and other limitations on our ability to conduct our business in the ordinary course.

These and similar, and perhaps more severe, disruptions in our operations could negatively impact our business, operating results and financial condition.

Further, quarantines, shelter-in-place and similar government orders, or the perception that such orders, shutdowns or other restrictions on the conduct of business operations could occur, related to COVID-19 or other infectious diseases could impact personnel at third-party manufacturing facilities in the United States and other countries, or the availability or cost of materials, which could disrupt our supply chain.

The FDA regulatory process may take longer and be more expensive than we anticipate without any assurance that we will obtain FDA approval.

If we are not able to obtain FDA approval for our lead product, we may not have the resources to develop any other product, and we may not be able to continue in business.

We may not be able to launch any products for which we receive FDA marketing approval.

We may not be able to establish a distribution network for the marketing and sale of any products for which we receive FDA approval.

We may not be able to establish manufacturing facilities in compliance with FDA good manufacturing practices or to enter into manufacturing agreements for the manufacture of our products in an FDA approved manufacturing facility.

It may be necessary to us to enter into a joint venture or other strategic relationship in order to develop, perform clinical testing for, manufacture or market any of our proposed products.

We may not be able to enter into such a relationship, and any relationship may not be successful, and the other party may have business interests and priorities that are different from ours.

We may be unable to accurately estimate anticipated expenses, capital requirements and needs for additional financing;

FDA regulatory process may take longer and be more expensive than we anticipate without any assurance that we will obtain FDA approval.

we are not able to obtain FDA approval for our lead product, we may not have the resources to develop any other product, and we may not

be able to continue in business.

may not be able to launch any products for which we receive FDA marketing approval.

may not be able to establish a distribution network for the marketing and sale of any products for which we receive FDA approval.

may not be able to establish manufacturing facilities in compliance with FDA good manufacturing practices or to enter into manufacturing

agreements for the manufacture of our products in an FDA approved manufacturing facility.

may be necessary to us to enter into a joint venture or other strategic relationship in order to develop, perform clinical testing for,

manufacture or market any of our proposed products.

We may not be able to enter into such a relationship, and any relationship may not

be successful, and the other party may have business interests and priorities that are different from ours.

may be unable to accurately estimate anticipated expenses, capital requirements and needs for additional financing;

Description of Exhibits

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Section 302 Certification of Chief Financial Officer.

Section 906 Certificate of Chief Executive Officer and Principal Financial Officer.

Section 906 Certification of Chief Executive Officer.

Section 906 Certification of Chief Financial Officer.

Inline XBRL Instance Document.

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NUTRIBAND INC.

December 13, 2023

/s/ Gareth Sheridan

2 unchanged sentences

(Principal Executive Officer)

December 13, 2023

May 31, 202 4

/s/ Gerald Goodman

1 unchanged sentence

Chief Financial Officer

(Principal Financial and Accounting Officer)

(Principal Financial Officer)

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-Q

Item 1A. Risk Factors