What changed in this filing

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Item 1. Business

2026-04-29 compared with 2025-04-28 · 212 added, 101 removed, 473 unchanged (40% of the section changed)

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Recent Developments

On October 28, 2025, we announced that we had

successfully completed a meeting with the United States Food and Drug Administration to obtain feedback on the Chemistry, Manufacturing,

and Controls plans for AVERSA™ FENTANYL (abuse deterrent transdermal system) from clinical development through commercialization.

The meeting was held as a videoconference on September 18, 2025 with the Division of Anesthesiology, Addiction Medicine, and Pain Medicine

(DAAP) in the Office of Neuroscience (ON), Center for Drug Evaluation and Research (CDER).

Nutriband received final meeting minutes from

FDA and is incorporating the feedback into the development program as it moves forward to an IND filing in support of a Human Abuse Potential

(HAP) clinical study for the product.

On February 13, 2025, we signed an addendum to

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including opioids and stimulants.

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 exposure.

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.

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 exposure.

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

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.

In January 2024, we signed a commercial development

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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.

Laboratory studies to be performed consist of 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.

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.

On February 13, 2025, we signed an addendum to the Commercial

Development and Clinical Supply Agreement to formalize our exclusive product development partnership and long-term commitment based on

shared development costs in exchange for milestone payments.

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.

Laboratory studies to be performed consist of 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.

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

assuming that the AVERSA™ abuse deterrent technology is incorporated into an already approved transdermal patch.

Acquisition of 4P Therapeutics

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the owner of 4P Therapeutics.

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

Nutriband acquired 4P Therapeutics for $2,250,000 which consisted of 62,500 shares of common stock, valued

at $1,850,000, and cash of $400,000.

The acquisition agreement requires that we 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 payments.

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 62,500 shares were issued to Mr.

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

Alan Smith (20,750 shares

Damon (41,750 shares pre-split) and

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.

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 Mr.

Damon to our board of directors in

April 2018, when we signed the acquisition agreement.

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

Damon resigned as a director in January 2022.

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

We believe that AVERSA Fentanyl, once approved by the

We believe that AVERSA™ Fentanyl, once approved

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

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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.

The value of the assets of the

Business that were acquired was (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

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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.

Our current focus is on developing our portfolio of 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

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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.

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

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market any of products that we develop.

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

The prioritization of our portfolio of product

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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

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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

based on a 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.

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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.

path for AVERSA™ Fentanyl is substantially limited compared to conventional pharmaceutical product development, following a limited

clinical program and NDA regulatory pathway, and 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.

FDA Prescription Drug User Fees

The Federal Food, Drug, and Cosmetic Act (FD&C

Act), as amended by the Prescription Drug User Fee Amendments of 2022 (PDUFA VII), authorizes FDA to collect application fees for certain

applications for the review of human drug and biological products and prescription drug program fees for certain approved products.

rates are calculated by factoring in the agency’s resources against the number of applications it expects to receive over the next

fiscal cycle based on historical trends and is updated on annual basis

For fiscal year 2026, the standard NDA application

fee requiring clinical data is $4,682,003 which is due upon the submission of the NDA.

We intend to seek a small business waiver for the

NDA application fee for our first product.

Under PDUFA, the FDA may grant a waiver to a small business for its first human drug application.

While we believe we meet the criteria because we have fewer than 500 employees and no prior approved products, there is no guarantee the

FDA will grant this waiver.

If the waiver is denied, we would be required to pay the full application fee.

For all of our prescription

pharmaceutical product candidates, failure to pay the fee or obtain a waiver in a timely manner would result in the FDA refusing to file

our application, which would significantly delay our ability to commercialize our products.

After approval, each prescription drug product

will be subject to the PDUFA annual prescription drug program fee.

The program fees are assessed for each prescription drug product that

is identified in a human drug application.

For fiscal year 2026, this fee is $442,213 per product.

Although, there is currently no small

business waiver for this fee, we may choose to petition the FDA for a Barrier to Innovation waiver.

However, there is no guarantee the

FDA will grant such a waiver, and we may be required to pay the full annual fee for each product.

Post-approval requirements

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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

regulations governing the research, development and manufacture of products containing controlled substances such as fentanyl and other

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

development and manufacturing activities.

Europe and Other Countries

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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.

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

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those countries.

Regulatory Meetings

AVERSA™ FENTANYL

On October 28, 2025, we announced that we had

successfully completed a Type C meeting with the United States Food and Drug Administration to obtain feedback on the Chemistry, Manufacturing,

and Controls plans for AVERSA™ FENTANYL (abuse deterrent transdermal system) from clinical development through commercialization.

The meeting was held as a videoconference on September18, 2025 with the Division of Anesthesiology, Addiction Medicine, and Pain Medicine

(DAAP) in the Office of Neuroscience (ON), Center for Drug Evaluation and Research (CDER).

Nutriband received final meeting minutes from

FDA and is incorporating the feedback into the development program as it moves forward to an IND filing in support of a Human Abuse Potential

(HAP) clinical study for the product.

The purpose of the meeting was to specifically

provide feedback on the Chemistry, Manufacturing, and Controls (CMC) plans for the product from submission of an Investigational New Drug

Application (IND) through approval of a 505(b)(2) New Drug Application (NDA).

The main outcomes of the meeting were:

● The FDA confirmed that the regulatory pathway for the product

is a 505(b)(2) NDA and provided guidance on the relied upon reference listed drug and bridging strategy.

● FDA provided expectations and constructive feedback on the

registration batch plan and manufacturing process validation strategy for NDA submission.

● FDA discussed various considerations and advice for the finalization

of the product specifications and stability testing plans for the clinical and commercial products.

● FDA provided feedback on the planned laboratory-based in

vitro manipulation and extraction studies (Category 1) to be conducted to fully characterize the product’s abuse-deterrent properties,

including the degree of effort required by an abuser to bypass or defeat those properties.

In addition, the Division acknowledged that fentanyl

patch abuse, misuse and accidental exposure is an important issue to address and offered their support and guidance during the development

program through additional meetings as needed.

In the past, the FDA has put out several warnings on the risks of fentanyl patch accidental

exposure, particularly in children, but to date there have not been any abuse deterrent fentanyl patches approved in the U.S, or in any

other country to our knowledge.

Nutriband’s abuse deterrent fentanyl patch has the potential to be the first abuse deterrent patch

approved worldwide.

To date, Nutriband has not had any guidance meetings

with regulatory authorities in any other country besides the United States for AVERSA™ Fentanyl or any other product in development,

but plans to engage international authorities as necessary, potentially with international development and sales/marketing partners, to

enable our product candidates to be launched in all major medical markets in the world.

Intellectual Property

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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.

Nutriband, or its subsidiaries, own the following

United States patents:

Patent Number

Title/Description

February 15, 2022

Abuse and Misuse Deterrent Transdermal Systems

September 19.

Abuse and Misuse Deterrent Transdermal Systems

On June 3, 2025 the United States Patent and Trademark

Office (USPTO) issued patent number 12,318,492 entitled “Abuse and Misuse Deterrent Transdermal Systems,” which contains expanded

claims to protect the commercial embodiment of Nutriband’s AVERSA™ abuse deterrent transdermal technology.

The issuance of

this patent further expands Nutriband’s intellectual property protection in the United States for its Aversa™ abuse deterrent

On October 3, 2025, Nutriband filed a new provisional

patent application with the U.S.

Patent and Trademark Office (USPTO) to further strengthen Nutriband’s intellectual property protection

for its AVERSA™ abuse deterrent transdermal technology.

The provisional patent application covers improved aversive formulations

and coating application methods to enhance the abuse deterrent properties of Nutriband’s AVERSA™ transdermal technology and

make it even more difficult to defeat.

If this provisional patent application is converted into a non-provisional patent application and

a new patent is subsequently granted, it could significantly extend the patent protection for products that utilize Nutriband’s

AVERSA™ abuse deterrent technology as the statutory patent term of a US patent is 20 years from the non-provisional filing date

which would extend patent coverage to 2046.

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

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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.

Our commercial success also depends in part on our

non-infringement of the patents or proprietary rights of third parties.

In addition to the protection afforded by patents,

we rely on trade secret protection and confidentiality agreements to protect proprietary know-how that is not patentable, including processes

for which patents are difficult to enforce and any other processes that involve proprietary know-how, information or technology that is

not covered by patents.

Although all of our employees, consultants, advisors and any third parties who have access to our proprietary

know-how, information or technology are required to enter into confidentiality agreements, we cannot provide any assurances that our trade

secrets and other confidential proprietary information will not be disclosed or that competitors will not otherwise gain access to our

trade secrets or independently develop substantially equivalent information and techniques.

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 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.

We have filed

a trademark application for the AVERSA™ wordmark in the United States with the United States Patent and Trademark Office (USPTO).

The USPTO will require us to file a Statement of Use (SOU) and show the mark used in interstate commerce prior to fully registering the

Nutriband, or its subsidiaries, own the following

United States trademarks:

Trademark Number

Serial 98371035

Serial 98371053

Serial 98371062

Serial 98117984

On October 10, 2025, we announced that we signed

an agreement with Brand Institute, Inc, the global leader in pharmaceutical and healthcare-related brand name and identity development

services to develop the worldwide commercial brand name and visual identity for its AVERSA™ Fentanyl product.

Developing a proprietary

brand name for a prescription drug product is a critical element in the drug product development process because the end users (doctors,

pharmacists, patients) must be able to easily distinguish a proprietary name from other drug names that are phonetically similar (sound-alike

names) or similar in their spelling or appearance (look-alike names).

In addition, if the drug name is otherwise confusing or misleading,

the patient might receive the wrong product and the subsequent medication error could lead to significant harm to the patient.

Brand Institute

has been responsible for a majority of the abuse deterrent opioid product brand names approved by FDA.

Scientific Publications

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Medicine (AAPM) Annual Meeting 2 .

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

pain care, education, advocacy, and research.

Academy of Pain Medicine (AAPM) is dedicated to advancing multidisciplinary pain care, education, advocacy, and research.

The company engaged Rocky Mountain Poison &

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

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

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

The data indicate that transdermal patch abuse

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company Health Advances to assess the market opportunity and commercial strategy for AVERSA™ Fentanyl and AVERSA™ Buprenorphine.

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

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 Fentanyl is the lead AVERSA product under

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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.

is also considering developing the product for strategic international markets as protected by its global abuse deterrent patent portfolio.

In addition, the market forecast did not take into account the price increases for marketed

generic fentanyl patches that have occurred since 2021.

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

AVERSA Buprenorphine is the second AVERSA product

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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