What changed in NutriBand Inc.'s 2023 10-K compared to 2022?

Across the narrative sections we track, NutriBand Inc. (NTRB) added 220 paragraphs, removed 242, and edited 155 between the 2022 and 2023 10-K filings. The biggest movers are Item 1A. Risk Factors (+79/−88), Item 7. Management's Discussion & Analysis (+75/−63), Item 1. Business (+55/−83).

Did NutriBand Inc. add new Risk Factors in the 2023 10-K?

Yes — Item 1A Risk Factors shows 79 new/edited paragraphs and 88 removed paragraphs versus the 2022 10-K.

What changed in NutriBand Inc.'s MD&A (Item 7) in 2023?

Item 7 Management's Discussion & Analysis shows 75 new/edited paragraphs and 63 removed paragraphs year-over-year. Read the side-by-side diff to see exactly which revenue, margin, and outlook commentary was rewritten.

Where does this NTRB 10-K diff come from?

The source filings are NutriBand Inc.'s official 2022 and 2023 Form 10-K annual reports from SEC EDGAR. 10q10k.net parses each filing, aligns paragraphs by section (Item 1, 1A, 1C, 2, 3, 7, 7A), and highlights every added, removed and edited sentence side-by-side.

What changed in NutriBand Inc.'s 10-K — 2022 vs 2023

Paragraph-level year-over-year comparison of NutriBand Inc.'s 2022 and 2023 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2023 report.

+220 added−242 removedSource: 10-K (2023-04-26) vs 10-K (2022-04-29)

Top changes in NutriBand Inc.'s 2023 10-K

220 paragraphs added · 242 removed · 155 edited across 6 sections

Item 1A. Risk Factors+79 / −88 · 62 edited
Item 7. Management's Discussion & Analysis+75 / −63 · 41 edited
Item 1. Business+55 / −83 · 47 edited
Item 5. Market for Registrant's Common Equity+8 / −5 · 2 edited
Item 2. Properties+2 / −2 · 2 edited

Item 1. Business

Business — how the company describes what it does

47 edited+8 added−36 removed77 unchanged

2022 filing

2023 filing

Biggest changeFactors which may affect our business include, but are not limited to, the following: ● Our 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. ● 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.

Biggest changeFactors 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.

One method is the decentralized procedure where we would apply for the 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.

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 and that the medicine is manufactured in accordance with good manufacturing practices based upon European Union standards.

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.

These drug trials are usually small, containing about 20 to 80 participants, according to the FDA. For drug delivery products incorporating already approved drugs, Phase 1 studies involve measuring blood levels of the drug to understand the pharmacokinetics for a new route of administration. ● Phase two clinical trial .

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 or drug release characteristics.

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

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.

In the case of drug delivery products that utilize an approved drug, Phase 3 trials will typically include a comparison to the already approved reference product. For example a transdermal patch may be compared to an injection. ● New drug application .

In the case of drug delivery products that utilize an approved drug, Phase 3 trials will typically include a comparison to the already approved reference product. For example, a transdermal patch may be compared to an injection. ● New drug application (NDA) .

For example, the regulatory path for the AVERSA products in development is intended follow a 505(b)(2) NDA regulatory pathway which 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.

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.

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. 12

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. 11 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 44 countries including the United States, Europe, Japan, Korea, Russia, Mexico, and Australia and with patents pending in Canada and China.

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. 7 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.

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) and Dr. Alan Smith (20,750 shares). In connection with the acquisition, Mr.

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).

The prioritization of our portfolio product candidates will be reviewed on an ongoing basis and will take into account technical progress, market potential and commercial interest. 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 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.

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 product applications for our transdermal technology to deliver proteins and peptides such as exenatide for type 2 diabetes and follicle stimulating hormone (FSH) for infertility.

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. 3 We are also exploring transdermal delivery of proteins and peptides such as exenatide for type 2 diabetes and follicle stimulating hormone (FSH) for infertility.

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.

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.

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 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.

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.

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 both 4P Therapeutics and Pocono Pharma.

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 first product under development is AVERSA Fentanyl, an abuse deterrent fentanyl transdermal system that combines an existing generic fentanyl patch with our AVERSA technology to reduce the abuse and misuse of fentanyl patches.

Our Business 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.

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 July 31, 2018, we had not generated any revenue from our business, which was the research and development of transdermal consumer patches.

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.

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, and we agreed to pay Mr. Damon the compensation received by independent board members.

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

We plan to follow on from this with development of additional products utilizing the AVERSA abuse deterrent transdermal technology, AVERSA Buprenorphine and AVERSA Methylphenidate. 5 Our lead product under development is our AVERSA Fentanyl product which is an abuse deterrent fentanyl patch for the treatment of chronic pain.

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.

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.

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.

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.

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.

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.

We have received a notice of allowance for the AVERSA trademark for our abuse deterrent technology in the United States. Competition 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 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. Competition The pharmaceutical industry is highly competitive and subject to rapid change as new products are developed and marketed.

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.

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.

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.

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 the fentanyl patch, this technology has broad applicability to any therapeutic patch where deterring abuse as well as accidental misuse by children and pets are valuable attributes.

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.

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. One example of such a product candidate is the development of a generic scopolamine patch.

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. 2 Effects of the COVID-19 Pandemic Our business may be affected by the COVID-19 pandemic and the response to the pandemic.

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.

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.

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. 10 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.

Our Business Our primary business is the development of a portfolio of transdermal pharmaceutical products. Our development pipeline consists of transdermal products that are based on our proprietary AVERSA ® abuse deterrent transdermal technology that can be incorporated into transdermal patches that contain drugs that are susceptible to abuse and misuse.

Our development pipeline consists of transdermal products that are based on our proprietary AVERSA® 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.

An ANDA may not be submitted if studies are necessary to establish the safety and effectiveness of the proposed product. This is the pathway taken for generic drugs.

An ANDA may not be submitted if studies are necessary to establish the safety and effectiveness of the proposed product. This is the pathway taken for generic drugs. 5 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.

This provides several advantages including physical separation of the aversive agents from the drug matrix, availability of aversive agents before and after use as well as 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.

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 feasibility agreement is focused on adapting Kindeva’s commercial transdermal manufacturing process to incorporate AVERSA technology. The product development program for AVERSA Fentanyl includes performing preclinical and clinical studies to demonstrate the abuse deterrent properties of the product.

The product development program for AVERSA Fentanyl includes performing preclinical and clinical studies to demonstrate the abuse deterrent properties of the product.

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 by providing them as transdermal patches. 2 We have signed a feasibility agreement for with Kindeva Drug Delivery, formerly 3M Drug Delivery, for the development of AVERSA Fentanyl using Kindeva’s FDA approved Fentanyl patch.

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 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. 9 Post-approval requirements Any drug products for which we receive FDA approval will be subject to continuing regulation by the FDA.

Post-approval requirements Any drug products for which we receive FDA approval will be subject to continuing regulation by the FDA.

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. 6 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.

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

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.

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. 8 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 compliance with current good manufacturing practices is satisfactory.

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.

Each country may require that additional clinical and nonclinical studies be conducted prior to approval. 7 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 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.

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.

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.

Presently, these products are only available by injection or oral routes. We believe that transdermal delivery has the potential to improve compliance, which can lead to improved therapeutic outcomes associated with these treatments. Exenatide (exendin-4) is a glucagon-like peptide-1 (GLP-1) receptor agonist which is approved to improve glycemic control in patients with type 2 diabetes mellitus.

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.

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.

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. 1 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.

We cannot assure you that we will obtain FDA marketing approval for any of our products. 3 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.

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.

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. Employees As of January 31, 2022, the Company has 13 full time employees, of which five are officers of the Company.

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 United States The pharmaceutical business is subject to extensive government regulation. In the United States, we must comply with the rules and regulations of the FDA.

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.

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.

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ITEM 1. BUSINESS SUMMARY This summary highlights information contained elsewhere in this report This summary does not contain all the information you should consider before investing in the securities.

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ITEM 1. BUSINESS. Overview Nutriband Inc. (the “Company”, “Nutriband”, “we” or “us”), was incorporated in Nevada in January 2016. Our primary business is the development of a portfolio of transdermal pharmaceutical products.

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However, you should read the entire report carefully, including the “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” and our financial statements, including the notes thereto, appearing elsewhere in this report. Our primary business is the development of a portfolio of transdermal pharmaceutical products.

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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.

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Our lead product is our AVERSA ™ technology, an abuse deterrent technology that can be added to a new or existing transdermal patch with the goal of deterring the abuse of certain drugs when delivered transdermally.

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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.

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Our first product under development is our AVERSA fentanyl patch (“AVERSA Fentanyl”) to provide clinicians and patients with an extended-release, transdermal-delivered fentanyl product for use in managing chronic pain requiring around the clock opioid therapy, combined with our AVERSA® technology to reduce the abuse and misuse of fentanyl patches.

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

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Following our acquisition of 4P Therapeutics on August 1, 2018, we are planning to develop, and seek FDA approval of, a number of transdermal pharmaceutical products under development by 4P Therapeutics.

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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.

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With the acquisition of the transdermal, topical, cosmetic and nutraceutical business of Pocono Coated Products, LLC effective August 31, 2020, we manufacture on a contract basis transdermal, topical, coated and consumer products.

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Selected Risks Associated with our Business and Operations Our business is subject to significant risks, which are disclosed in more detail under “Risk Factors,” which begins on page 13, as a result of which an investment in our common stock is highly speculative and could result in the loss of your entire investment.

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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.

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Significant risks include, but are not limited to, the following: ● 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.

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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.

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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.

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

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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. 1 ● 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 will 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.

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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 not be able to protect our rights in our intellectual property, and we may be subject to intellectual property litigation which would be expensive and disruptive of our operations even if we eventually prevail on the merits. ● Unanticipated side effects or other adverse events resulting from the use of our product could require a recall of our products and, even if no recall is required, our reputation could be impaired by side effects. ● We may fail to comply with all applicable laws and regulations relating to our product.

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We may have to change or adapt our operations in the event of changes in national, regional and local government regulations, taxation, controls and political and economic developments that affect our products and the market for our products; ● We may be unable to accurately estimate anticipated expenses, capital requirements and needs for additional financing; ● The terms of our recent financing, including the antidilution provisions of the warrants, may impair our ability to raise funds for our operations during the term of the warrants.

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We have not taken any steps to seek to obtain FDA approval for any of our consumer products in development, and we have no plans to do so in the near term.

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Acquisition of Pocono Coated Products On August 25, 2020, the Company formed Pocono Pharmaceuticals Inc.(“Pocono”), a wholly owned subsidiary of the Company.

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Implications of Being an Emerging Growth Company As a company with less than $1.07 billion in revenue during our last fiscal year, we qualify as an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act.

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An emerging growth company may take advantage of reduced reporting requirements that are otherwise generally applicable to public companies, although as a smaller reporting company we are taking advantage of reduced reporting requirements.

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In particular, as an emerging growth company, we: ● may present only two years of audited financial statements and related disclosure under Management’s Discussion and Analysis of Financial Condition and Results of Operations, or MD&A; ● are not required to provide a detailed narrative disclosure discussing our compensation principles, objectives and elements and analyzing how those elements fit with our principles and objectives, which is commonly referred to as “compensation discussion and analysis”; ● are not required to obtain an attestation and report from our auditors on our management’s assessment of our internal control over financial reporting pursuant to the Sarbanes-Oxley Act of 2002; 4 ● are not required to obtain a non-binding advisory vote from our stockholders on executive compensation or golden parachute arrangements (commonly referred to as the “say-on-pay,” “say-on frequency” and “say-on-golden-parachute” votes); ● are exempt from certain executive compensation disclosure provisions requiring a pay-for-performance graph and chief executive officer pay ratio disclosure; ● are not required to conduct an evaluation of our internal control over financial reporting by our auditors.

Removed

We intend to take advantage of all of these reduced reporting requirements and exemptions. However, since we have already adopted certain new or revised accounting standards under §107 of the JOBS Act, we are not able to take advantage of the delayed phase in of the new or revised accounting standards.

Removed

Under the JOBS Act, we may take advantage of the above-described reduced reporting requirements and exemptions for up to five years after our initial sale of common equity pursuant to a registration statement declared effective under the Securities Act of 1933, as amended, or such earlier time that we no longer meet the definition of an emerging growth company.

Removed

The JOBS Act provides that we would cease to be an “emerging growth company” if we have more than $1.07 billion in annual revenues (as adjusted for inflation), have more than $700 million in market value of our common stock held by non-affiliates, or issue more than $1 billion in principal amount of non-convertible debt over a three-year period.

Removed

Under current Securities and Exchange Commission, or SEC, rules however, we will continue to qualify as a “smaller reporting company” for so long as we have either (i) a public float (i.e., the market value of common equity held by non-affiliates) of less than $250 million as of the last business day of our most recently completed second fiscal quarter or (ii) annual revenues of less than $100 million and a public float of less than $700 million.

Removed

Effects of the COVID-19 Pandemic Our business may be affected by the COVID-19 pandemic and the response to the pandemic.

Removed

Exenatide is currently approved as a twice-daily subcutaneous injection or as a once-weekly injection. However, many patients have a strong aversion to needles, resist initiation of injections even when oral agents are failing to control their diabetes and struggle with compliance after starting therapy.

Removed

We have performed pre-clinical work on the development of a novel transdermal patch for administration of exenatide to match the therapeutic plasma levels achieved by subcutaneous injections of exenatide. However, we need substantial funds before we can continue these efforts.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

62 edited+17 added−26 removed123 unchanged

2022 filing

2023 filing

Biggest changeIn order to market and sell our products in jurisdictions other than the United States, we must obtain separate marketing approvals and comply with numerous and varying regulatory requirements. The regulatory approval process outside the United States generally includes all of the risks associated with obtaining FDA and can involve additional testing.

Biggest changeBefore 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 other than the United States, we must obtain separate marketing approvals and comply with numerous and varying regulatory requirements.

Our business will be likely be adversely affected by the COVID-19 pandemic.

Our business will likely be adversely affected by the COVID-19 pandemic.

Further, stocks with a low trading volume may be more subject to manipulation than a stock that has a significant public float and is actively traded. The price of our stock may fluctuate significantly in response to a number of factors, many of which are beyond our control.

If the additional equity securities were issued at a per share price less than the market price, which is customary in the private placement of equity securities, the holders of the outstanding shares would suffer dilution, which could be significant.

We will need to raise substantial funds in order to develop our products.

In order to raise additional capital, we may in the future offer additional shares of our common stock or other securities convertible into or exchangeable for our common stock at prices that may not which is less than the market price and which may be based on a discount from market at the time of issuance.

Stockholders will incur dilution upon exercise of any outstanding stock options, warrants or upon the issuance of shares of common stock under our present and future stock incentive programs.

In addition, the sale of shares and any future sales of a substantial number of shares of our common stock in the public market, or the perception that such sales may occur, could adversely affect the price of our common stock.

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. ● The integration of any acquisition with our existing business may be difficult and, if we are not able to integrate the business successfully, we may not only be unable to operate the business profitably, but management may be unable to devote the necessary time to the development of our existing business; ● The key employees who operated the acquired business successfully prior to the acquisition may not be happy working for us and may resign, thus leaving the business without the necessary continuity of management. ● Even if the business is successful, our senior executive officers may need to devote significant time to the acquired business, which may distract them from their other management activities. ● If the business does not operate as we expect, we may incur an impairment charge based on the value of the assets acquired. 24 ● The products or proposed products of the acquired company may have regulatory problems with the FDA or any other regulatory agency, including the need for additional and unanticipated testing or the need for a recall or a change in labeling. ● We may have difficulty maintaining the necessary quality control over the acquired business and its products and services. ● To the extent that an acquired company operates at a loss prior to our acquisition, we may not be able to develop profitable operations following the acquisition. ● The acquired company may have liabilities or obligations which were not disclosed to us, or the acquired assets, including any intellectual property, may not have the value we anticipated. ● The assets, including intellectual property, of the acquired company may not have the value that we anticipated. ● We may require significant capital both to acquire and to operate the business, and the capital requirements of the business may be greater than we anticipated.

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. ● The integration of any acquisition with our existing business may be difficult and, if we are not able to integrate the business successfully, we may not only be unable to operate the business profitably, but management may be unable to devote the necessary time to the development of our existing business; ● The key employees who operated the acquired business successfully prior to the acquisition may not be happy working for us and may resign, thus leaving the business without the necessary continuity of management. ● Even if the business is successful, our senior executive officers may need to devote significant time to the acquired business, which may distract them from their other management activities. ● If the business does not operate as we expect, we may incur an impairment charge based on the value of the assets acquired. ● The products or proposed products of the acquired company may have regulatory problems with the FDA or any other regulatory agency, including the need for additional and unanticipated testing or the need for a recall or a change in labeling. ● We may have difficulty maintaining the necessary quality control over the acquired business and its products and services. ● To the extent that an acquired company operates at a loss prior to our acquisition, we may not be able to develop profitable operations following the acquisition. ● The acquired company may have liabilities or obligations which were not disclosed to us, or the acquired assets, including any intellectual property, may not have the value we anticipated. ● The assets, including intellectual property, of the acquired company may not have the value that we anticipated. ● We may require significant capital both to acquire and to operate the business, and the capital requirements of the business may be greater than we anticipated.

The clinical and commercial success of our product candidates depends on a number of factors, many of which are beyond our control, including: ● the FDA’s acceptance of our parameters for regulatory approval relating to our product candidates, including our proposed indications, primary endpoint assessments, primary endpoint measurements and regulatory pathways; ● the FDA’s acceptance of the number, design, size, conduct and implementation of our clinical trials, our trial protocols and the interpretation of data from preclinical studies or clinical trials; ● the FDA’s acceptance of the sufficiency of the data we collect from our preclinical studies and pivotal clinical trials to support the submission of a New Drug Application, known as an NDA, without requiring additional preclinical or clinical trials; ● the FDA’s acceptance of our abuse deterrent labelling relating to our products, including our abuse deterrent fentanyl transdermal system; ● when we submit our NDA upon completion of our clinical trials, the FDA’s willingness to schedule an advisory committee meeting, if applicable, in a timely manner to evaluate and decide on the approval of our NDA; ● the recommendation of the FDA’s advisory committee, if applicable, to approve our application without limiting the approved labelling, specifications, distribution or use of the products, or imposing other restrictions; ● our ability to satisfy any issued raised by the FDA in response to our test data; ● the FDA’s satisfaction with the safety and efficacy of our product candidates; ● the prevalence and severity of adverse events associated with our product candidates; 16 ● the timely and satisfactory performance by third party contractors of their obligations in relation to our clinical trials; ● 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; ● the availability, perceived advantages and relative cost of alternative and competing treatments; ● the effectiveness of our marketing, sales and distribution strategy and operations; ● our ability to develop, validate and maintain a commercially viable manufacturing process that is compliant with current good manufacturing practices; ● our ability to obtain, protect and enforce our intellectual property rights; ● our ability to bring an action timely for patent infringement arising out of the filing of ANDAs by generic companies seeking approval to market generic versions of our products, if applicable, before the expiry of our patents; and ● our ability to avoid third party claims of patent infringement or intellectual property violations.

The clinical and commercial success of our product candidates depends on a number of factors, many of which are beyond our control, including: ● the FDA’s acceptance of our parameters for regulatory approval relating to our product candidates, including our proposed indications, primary endpoint assessments, primary endpoint measurements and regulatory pathways; ● the FDA’s acceptance of the number, design, size, conduct and implementation of our clinical trials, our trial protocols and the interpretation of data from preclinical studies or clinical trials; ● the FDA’s acceptance of the sufficiency of the data we collect from our preclinical studies and pivotal clinical trials to support the submission of a New Drug Application, known as an NDA, without requiring additional preclinical or clinical trials; ● the FDA’s acceptance of our abuse deterrent labelling relating to our products, including our abuse deterrent fentanyl transdermal system; ● when we submit our NDA upon completion of our clinical trials, the FDA’s willingness to schedule an advisory committee meeting, if applicable, in a timely manner to evaluate and decide on the approval of our NDA; ● the recommendation of the FDA’s advisory committee, if applicable, to approve our application without limiting the approved labelling, specifications, distribution or use of the products, or imposing other restrictions; ● our ability to satisfy any issued raised by the FDA in response to our test data; ● the FDA’s satisfaction with the safety and efficacy of our product candidates; ● the prevalence and severity of adverse events associated with our product candidates; ● the timely and satisfactory performance by third party contractors of their obligations in relation to our clinical trials; ● 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 to achieve conduct the necessary clinical trials; ● the availability, perceived advantages and relative cost of alternative and competing treatments; ● the effectiveness of our marketing, sales and distribution strategy and operations; ● our ability to develop, validate and maintain a commercially viable manufacturing process that is compliant with current good manufacturing practices; ● our ability to obtain, protect and enforce our intellectual property rights; ● our ability to bring an action timely for patent infringement arising out of the filing of ANDAs by generic companies seeking approval to market generic versions of our products, if applicable, before the expiry of our patents; and ● our ability to avoid third party claims of patent infringement or intellectual property violations.

As a result, they have the effective power using their contacts with a limited number of other shareholders to elect all of our directors and to approve any action requiring stockholder approval. 29 Raising funds by issuing equity or convertible debt securities could dilute the net tangible book value of the common stock and impose restrictions on our working capital.

As a result, they have the effective power using their contacts with a limited number of other shareholders to elect all of our directors and to approve any action requiring stockholder approval. Raising funds by issuing equity or convertible debt securities could dilute the net tangible book value of the common stock and impose restrictions on our working capital.

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. If we do not have sufficient product liability insurance, we may be subject to claims that are in excess of our net worth.

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. 14 If we do not have sufficient product liability insurance, we may be subject to claims that are in excess of our net worth.

Because we are an early-stage company, our reputation, and our ability to market products, could be affected more severely than a major pharmaceutical company. 18 In addition, the use of our products could be associated with serious and unexpected adverse events, or with less serious reactions at a greater than expected frequency.

Because we are an early-stage company, our reputation, and our ability to market products, could be affected more severely than a major pharmaceutical company. In addition, the use of our products could be associated with serious and unexpected adverse events, or with less serious reactions at a greater than expected frequency.

We cannot predict the effect, if any, that market sales of those shares of common stock or the availability of those shares of common stock for sale will have on the market price of our common stock. We may issue preferred stock whose terms could adversely affect the voting power or value of our common stock.

We cannot predict the effect, if any, that market sales of those shares of common stock or the availability of those shares of common stock for sale will have on the market price of our common stock. 22 We may issue preferred stock whose terms could adversely affect the voting power or value of our common stock.

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.

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. 21 If we seek to market any products in our pipeline in countries other than the United States, we will need to comply with the regulations of each country in which we seek to market our products.

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. 15 If we seek to market any products in our pipeline in countries other than the United States, we will need to comply with the regulations of each country in which we seek to market our products.

The AVERSA abuse deterrent technology utilized in our AVERSA product pipeline is covered by an international intellectual property portfolio with patents issued in 44 countries including the United States, Europe, Japan, Korea, Russia, Mexico, and Australia. Patent prosecution is still pending in Canada and China. These patents provide patent coverage to 2035.

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. Patent prosecution is still pending in China. These patents provide patent coverage to 2035.

Further, if we are able to raise funds from the sale of debt securities, the lenders may impose restrictions on our operations and may impair our working capital as we service any such debt obligations. Stockholders may experience significant dilution as a result of future equity offerings and other issuances of our common stock or other securities.

Further, if we are able to raise funds from the sale of debt securities, the lenders may impose restrictions on our operations and may impair our working capital as we service any such debt obligations. Stockholders may experience significant dilution from future equity offerings and other issuances of our common stock or other securities.

Because of our executive officers’ stock ownership and stock ownership of certain other stockholders that have invested in the company, these stockholders have the power to elect all directors and to approve any action requiring stockholder approval. Our officers and directors as a group beneficially own approximately 32% of our common stock.

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

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

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.

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.

Our failure to obtain funds on reasonable terms may impair the value of the acquisition. ● The acquired company may not operate at the revenue level or with the gross margin shown in the financial statements or projections. ● Patents may not be granted for patent applications which the acquired company filed or patents may be successfully challenged. ● There may be conflicts in management styles that prevent us from integrating the acquired company with us. ● The former equity owners or officers may compete in violation of their non-competition covenants or the non-competition covenants may be held to be unenforceable. ● The business of the acquired company may have problems of which management was unaware and which do not become evident until after the acquisition and we may require significant funding to remedy the problem. ● The indemnification obligations of the seller under the purchase agreement, if any, may be inadequate to compensate us for any loss, damage or expense which we may sustain, including undisclosed claims or liabilities. ● To the extent that the acquired company is dependent upon its management to maintain relationships with existing customers, we may have difficulty in retaining the business of these customers if there is a change in management. ● Government agencies may seek damages after we make the acquisition for conduct which occurred prior to the acquisition and we may not have adequate recourse against the seller.

At any point, the FDA could ask us to perform additional tests or to refine and redo a test that we had previously completed. The process of obtaining FDA approval could take many years, with no assurance that the FDA will approve the product. The FDA also will need to approve the manufacturing process and the manufacturing facility.

These factors include, but are not limited to, the following, in addition to the risks described above and general market and economic conditions: ● the market’s reaction to our financial condition and its perception of our ability to raise necessary funding or enter into a joint venture, given the economic environment resulting from the COVID-19 pandemic, as well as its perception of the possible terms of any financing or joint venture; ● the market’s perception as to our ability to generate positive cash flow or earnings; ● changes in our or any securities analysts’ estimate of our financial performance; ● the perception of our ability to raise the necessary financing to complete the product development activities including preclinical and clinical testing required for FDA approval and our ability to generate revenue and cash flow from our products; ● the anticipated or actual results of our operations; ● changes in market valuations of other companies in our industry; ● litigation or changes in regulations and insurance company reimbursement policies affecting prescription drugs; ● concern that our internal controls are ineffective; ● any discrepancy between anticipated or projected results and actual results of our operations; ● actions by third parties to either sell or purchase stock in quantities which would have a significant effect on our stock price; and ● other factors not within our control. 27 Raising funds by issuing equity or convertible debt securities could dilute the net tangible book value of the common stock and impose restrictions on our working capital.

These factors include, but are not limited to, the following, in addition to the risks described above and general market and economic conditions: ● the market’s reaction to our financial condition and its perception of our ability to raise necessary funding or enter into a joint venture, given the economic environment resulting from the COVID-19 pandemic, as well as its perception of the possible terms of any financing or joint venture; ● the market’s perception as to our ability to generate positive cash flow or earnings; 19 ● changes in our or any securities analysts’ estimate of our financial performance; ● the perception of our ability to raise the necessary financing to complete the product development activities including preclinical and clinical testing required for FDA approval and our ability to generate revenue and cash flow from our products; ● the anticipated or actual results of our operations; ● changes in market valuations of other companies in our industry; ● litigation or changes in regulations and insurance company reimbursement policies affecting prescription drugs; ● concern that our internal controls are ineffective; ● any discrepancy between anticipated or projected results and actual results of our operations; ● actions by third parties to either sell or purchase stock in quantities which would have a significant effect on our stock price; and ● other factors not within our control.

For example: ● others may be able to make compositions or formulations that are similar to our product s but that are not covered by the claims of our patents; ● other persons may have filed patents covering inventions, technology or processes that we use, with the result that we may infringe upon the prior patents; ● others may independently develop similar or alternative technologies or duplicate any of our technologies; ● our pending patent applications may not result in the grant of patents; ● any patents which may be issued may not provide us with any competitive advantages, or may be held invalid or unenforceable as a result of legal challenges by third parties; ● our inability to fund any litigation to defend our proprietary rights, either in defense of an action against us or a plaintiff to seek to prevent infringement. ● our failure to develop additional proprietary technologies that are patentable.

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: ● Our 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. ● 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. 13 Because we do not have a product we can market in the United States, we cannot predict when or whether we will operate profitably.

The COVID-19 pandemic and the response to the 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. 9 Because we do not have a product we can market in the United States, we cannot predict when or whether we will operate profitably.

As a result, any reported prices may not reflect the price at which you would be able to sell shares of common stock if you want to sell any shares you own or buy if you wish to buy shares.

The trading volume in our stock is low, which may result in volatility in our stock price. As a result, any reported prices may not reflect the price at which you would be able to sell shares of common stock if you want to sell any shares you own or buy if you wish to buy shares.

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.

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.

In addition to consenting to the cease-and-desist orders, the officers have each agreed to pay a $25,000 civil penalty to resolve the investigation. The administrative order does not impose a civil penalty or any other monetary relief against us.

In the event of a de-listing, we would take actions to restore our compliance with Nasdaq’s listing requirements, but we can provide no assurance that any such action taken by us would allow our Common Stock to become listed again, stabilize the market price or improve the liquidity of our Common Stock, prevent our Common Stock from dropping below the Nasdaq minimum bid price requirement or prevent future non-compliance with Nasdaq’s listing requirements.

In 2017, we issued 1,250,000 shares of common stock, 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 value of the intellectual property we were to have acquired did not have the value we anticipated, with the result that we incurred a $2,500,000 impairment loss in the year ended January 31, 2018.

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 value of the intellectual property we were to have acquired did not have the value we anticipated, with the result that we incurred a $2,500,000 impairment loss in the year ended January 31, 2018.

Patient enrollment is also a significant factor in the timely completion of clinical trials and is affected by many factors, including the size and nature of the patient population, the proximity of patients to clinical sites, the eligibility criteria for the trial, the design of the clinical trial, competing clinical trials and clinicians’ and patients’ perceptions as to the potential advantages of the drug being studied in relation to available alternatives, including any new drugs or treatments that may be approved for the indications we are investigating. 15 We may also encounter delays if a clinical trial is suspended or terminated by us, by the independent review boards of the institutions in which such trials are being conducted, by the trial’s data safety monitoring board, or by the FDA.

We have not paid any cash dividends on our common stock and do not intend to pay cash dividends on our common stock in the foreseeable future. 30 ITEM 1B. UNRESOLVED STAFF COMMENTS. Not applicable.

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

We anticipate that we will require funds in addition to the net proceeds from this offering for our business. If we were to raise capital by issuing equity securities, either alone or in connection with a non-equity financing, the net tangible book value of the then outstanding common stock could decline.

If we were to raise capital by issuing equity securities, either alone or in connection with a non-equity financing, the net tangible book value of the then outstanding common stock could decline.

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.

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.

Certain countries allow companies to fix their own prices for medicines but monitor the pricing. 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.

If a manufacturer fails to comply with all applicable regulations, the FDA can prohibit us from distributing products manufactured in those facilities, whether they are a contract manufacturer or own facility. Failure to be in compliance with good manufacturing practices could result in the FDA closing the facilities or limiting our use of the facilities.

Failure to be in compliance with good manufacturing practices could result in the FDA closing the facilities or limiting our use of the facilities. 17 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.

If we are not able to obtain necessary financing to develop, obtain FDA marketing approval and market this product successfully, we may not have the resources to develop additional products, and we may not be able to continue in business. 14 Before we can market in the United States any product which is classified by the FDA as a drug, we must obtain FDA marketing approval.

Pursuant to Section 404 of the Sarbanes-Oxley Act, we are required to file a report by our management on our internal control over financial reporting. Our disclosure controls and our internal controls over financial reporting are not effective.

Risks Concerning our Securities Our lack of internal controls over financial reporting may affect the market for and price of our common stock. Pursuant to Section 404 of the Sarbanes-Oxley Act, we are required to file a report by our management on our internal control over financial reporting.

Our future success depends, to a significant extent, on our ability to attract, train and retain key management, technical, regulatory and financial personnel. Recruiting and retaining capable personnel with experience in pharmaceutical product development is vital to our success. There is substantial competition for qualified personnel, and, competition is likely to increase.

If we are unable to attract, train and retain technical and financial personnel, our business may be materially and adversely affected. Our future success depends, to a significant extent, on our ability to attract, train and retain key management, technical, regulatory and financial personnel. Recruiting and retaining capable personnel with experience in pharmaceutical product development is vital to our success.

Numerous proposals that would effect changes in the United States healthcare system have been introduced or proposed in Congress and in some state legislatures, including reducing reimbursement for prescription products and reducing the levels at which consumers and healthcare providers are reimbursed for purchases of pharmaceutical products. 22 Cost reduction initiatives and changes in coverage implemented through legislation or regulation could decrease utilization of and reimbursement for any approved products, which in turn would affect the price we can receive for those products.

If we obtain FDA approval to market our products, we expect to spend considerable time and money complying with federal and state laws and regulations governing their sale, and, if we are unable to fully comply with such laws and regulations, we could face substantial penalties.

A serious adverse finding concerning the risk of any of our products by any regulatory authority could adversely affect our reputation, business and financial results. 13 If we obtain FDA approval to market our products, we expect to spend considerable time and money complying with federal and state laws and regulations governing their sale, and, if we are unable to fully comply with such laws and regulations, we could face substantial penalties.

We plan to sell our transdermal consumer products to distributors in those countries in which the products can be sold in compliance with all applicable regulations without our spending significant monies for preclinical and clinical studies to obtain regulatory approval. We are dependent upon our chief executive officer, our president and our chief operating officer.

We do not plan to seek FDA approval or market these products in the United States at this time. We plan to sell our transdermal consumer products to distributors in those countries in which the products can be sold in compliance with all applicable regulations without our spending significant monies for preclinical and clinical studies to obtain regulatory approval.

Our failure to comply with any of these federal and state health care laws and regulations, or health care laws in foreign jurisdictions, could have a material adverse effect on our business, financial condition, result of operations and cash flows. 19 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.

Even if we were to receive approval in the United States, approval by the FDA for marketing in the United States does not ensure approval by regulatory authorities in other countries. Similarly, approval by one regulatory authority outside the United States would not ensure approval by regulatory authorities in other countries.

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, approval by the FDA for marketing in the United States does not ensure approval by regulatory authorities in other countries.

We are dependent upon Gareth Sheridan, our chief executive officer, Serguei Melnik, our president and Dr. Alan Smith, our chief operating officer who is president of 4P Therapeutics. Although Mr. Sheridan and Mr. Melnik have employment agreements with us, the employment agreements does not guarantee that the officer will continue with us.

We are dependent upon our chief executive officer, our president and our chief operating officer. We are dependent upon Gareth Sheridan, our chief executive officer, Serguei Melnik, our president and Dr. Alan Smith, our chief operating officer who is president of 4P Therapeutics.

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. 23 The degree of future protection for our proprietary rights is uncertain because legal means afford only limited protection and may not adequately protect our rights or permit us to gain or keep our competitive advantage.

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.

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.

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.

Our ability to finance our operations and generate revenues depends on the clinical and commercial success of our abuse deterrent fentanyl transdermal system and our other related product candidates and failure to achieve such success will negatively impact our business.

In addition, many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of our product candidates. 11 Our ability to finance our operations and generate revenues depends on the clinical and commercial success of our abuse deterrent fentanyl transdermal system and our other related product candidates and failure to achieve such success will negatively impact our business.

We cannot assure you we will be able to attract or retain the personnel we require. Our financial condition is likely to impair our ability to attract qualified candidates.

There is substantial competition for qualified personnel, and competition is likely to increase. We cannot assure you we will be able to attract or retain the personnel we require. Our financial condition is likely to impair our ability to attract qualified candidates. If we are unable to attract and retain qualified employees, our business may be materially and adversely affected.

Our proposed transdermal products are drug-device 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.

We cannot market our consumer transdermal patch products in the United States without first obtaining FDA approval. We do not plan to seek FDA approval or market these products in the United States at this time.

We do not currently sell or market our consumer transdermal products domestically, or for our international sales, directly to international consumers, and we rely on distributors to sell and market these products. We cannot market our consumer transdermal patch products in the United States without first obtaining FDA approval.

We cannot assure you that we will not face significant liability as a result of such side effects and we may not have sufficient product liability insurance to cover any damages that may be assessed against us. 20 Because of our lack of funds, we may have to enter into a joint venture or strategic relationship or licensing agreement with a third party to develop and seek to obtain FDA approval of our potential products.

Accordingly, even if we obtain FDA approval to market our products, we may not be able to generate sufficient revenues through the sale of our products to enable us to continue our business.

Accordingly, even if we obtain FDA approval to market our products, we may not be able to generate sufficient revenues through the sale of our products to enable us to continue our business. 12 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 thereof becomes compliant.

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 foreign jurisdictions, the commercial prospects of those product candidates may be significantly diminished and our business prospects could be impaired.

If we are unable to obtain approval of our product candidates by regulatory authorities in foreign jurisdictions, the commercial prospects of those product candidates may be significantly diminished and our business prospects could be impaired. Outside the United States, particularly in member states of the European Union, the pricing of prescription drugs is subject to governmental control.

If we seek to expand our business through acquisition, we may not be successful in identifying acquisition targets or integrating their businesses with our existing business. We have recently expanded our business by acquisition, and we may make acquisitions in the future.

We have recently expanded our business by acquisition, and we may make acquisitions in the future.

We may need to rely on a contract research organization to conduct 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.

The FDA also will need to approve the manufacturing process and the manufacturing facility. 10 We may need to rely on a contract research organization to conduct our preclinical and clinical trials. We may need to rely on third party contract research organizations to conduct our preclinical and clinical trials.

In addition, there can be considerable pressure by governments and other stakeholders on prices and reimbursement levels, including as part of cost containment measures. Certain countries allow companies to fix their own prices for medicines but monitor the pricing.

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, 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.

The regulatory approval process outside the United States generally includes all of the risks associated with obtaining FDA and 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 are dependent on third party distributors for the international marketing of our consumer products and complying with applicable laws. We do not currently sell or market our consumer transdermal products domestically, or for our international sales, directly to international consumers, and we rely on distributors to sell and market these products.

We cannot assure you that any acquisition we complete will be successful. We are dependent on third party distributors for the international marketing of our consumer products and complying with applicable laws.

We do not have an employment agreement with Dr. Smith. The loss of Mr. Sheridan, Mr. Melnik or Dr. Smith would materially impair our ability to conduct our business. If we are unable to attract, train and retain technical and financial personnel, our business may be materially and adversely affected.

These officers have employment agreements with us, but the employment agreements do not guarantee that the officer will continue with us. The loss of any one of Mr. Sheridan, Mr. Melnik or Dr. Smith would materially impair our ability to conduct our business.

Removed

Added

Before we can market in the United States any product which is classified by the FDA as a drug, we must obtain FDA marketing approval. Our proposed transdermal products are drug-device combinations that are considered by the FDA to be drugs, which require approval by the FDA.

Removed

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.

Added

We may also encounter delays if a clinical trial is suspended or terminated by us, by the independent review boards of the institutions in which such trials are being conducted, by the trial’s data safety monitoring board, or by the FDA.

Removed

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

Added

Similarly, approval by one regulatory authority outside the United States would not ensure approval by regulatory authorities in other countries. We may not be able to file for marketing approvals and may not receive necessary approvals to commercialize our products in any market.

Removed

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.

Added

Because of our lack of funds, we may have to enter into a joint venture or strategic relationship or licensing agreement with a third party to develop and seek to obtain FDA approval of our potential products.

Removed

By relying on a contract manufacturer, we will be dependent upon the manufacturer, whose interests may be different from ours. Any contract manufacturer will be responsible for product quality and for meeting regulatory requirements.

Added

Cost reduction initiatives and changes in coverage implemented through legislation or regulation could decrease utilization of and reimbursement for any approved products, which in turn would affect the price we can receive for those products.

Removed

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.

Added

The degree of future protection for our proprietary rights is uncertain because legal means afford only limited protection and may not adequately protect our rights or permit us to gain or keep our competitive advantage.

Removed

Regardless of whether we are able to make a claim against the contract manufacturer, our reputation may be harmed and we may lose business as a result. Further, the contract manufacturer may have other customers and may allocate its resources based on the contract manufacturer’s interest rather than our interest.

Added

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.

Removed

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 compliant.

Added

Our disclosure controls and our internal controls over financial reporting are not effective.

Removed

A serious adverse finding concerning the risk of any of our products by any regulatory authority could adversely affect our reputation, business and financial results.

Added

Raising funds by issuing equity or convertible debt securities could dilute the net tangible book value of the common stock and impose restrictions on our working capital. We anticipate that we will require funds in addition to the net proceeds from this offering for our business.

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Item 2. Properties

Properties — owned and leased real estate

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2022 filing

2023 filing

Biggest changeWe lease manufacturing space in Cherryville, North Carolina, for $3,000 per month under a three-year lease entered into on February 1, 2022, with a renewal option.

Biggest changeWe lease manufacturing space in Cherryville, North Carolina, for $3,000 per month under a three-year lease entered into on February 1, 2022, with a renewal option. ITEM 3. LEGAL PROCEEDINGS None. ITEM 4. MINE SAFETY DISCLOSURES. Not Applicable 23 PART II

ITEM 2. PROPERTIES We do not own any real property. We lease under a one year lease an office for $ 2,500 per month at 121 South Orange Street, Orlando, Florida. With the office lease, we have access to board rooms, kitchen facilities and administrative support services.

ITEM 2. PROPERTIES Property We do not own any real property. We lease under a one year lease an office for $ 2,500 per month at 121 South Orange Street, Orlando, Florida. With the office lease, we have access to boardrooms, kitchen facilities and administrative support services.

Item 4. Mine Safety Disclosures

Mine Safety Disclosures — required of mining issuers

1 edited+0 added−0 removed0 unchanged

2022 filing

2023 filing

Biggest changeItem 4. Mine Safety Disclosures 31 PART II Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 32 Item 6. [Reserved] 32 Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations 33 Item 7A. Quantitative and Qualitative Disclosures About Market Risk 38 Item 8.

Biggest changeItem 4. Mine Safety Disclosures 23 PART II Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 24 Item 6. [Reserved] 25 Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations 26 Item 7A. Quantitative and Qualitative Disclosures About Market Risk 31 Item 8.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

2 edited+6 added−3 removed2 unchanged

2022 filing

2023 filing

Biggest changeShareholders of Record As of April 15, 2022, we had approximately 83 holders of record of our common stock based upon data provided by our transfer agent; our Warrants are held in book entry form by the Depository Trust Corporation.

Biggest changeShareholders of Record As of April 15, 2023, we had approximately 77 holders of record of our common stock; our Warrants are held in book entry form by the Depository Trust Corporation, which is the holder of record of all of the publicly-traded warrants, based upon data provided by our transfer agent.

In December 2021, the Company purchased 28,125 shares of its common stock for $104,467 and recorded the purchase as Treasury Stock as of January 31, 2022.

Issuer Purchases of Equity Securities During the year ended January 31,2023, the Company purchased 35,584 shares of its common stock for $119,006 and recorded the purchase as Treasury Stock.

Removed

Sales of Unregistered Securities The following table sets forth the sales of unregistered securities since the Company’s last report filed under this item. Date Title and Amount (1) Purchaser Principal Underwriter Total Offering Price/ Underwriting Discounts December 30, 2021 10,000 shares of common stock. Consultant.

Added

Dual Listing on Upstream We have set up the dual listing of our common stock (“common stock”) on the MERJ Upstream stock exchange, operated by MERJ Exchange (“Upstream”), that is an exchange registered in the Seychelles under the Seychelles Securities Act, 2007.

Removed

NA $ 66,900 /NA Issuer Purchases of Equity Securities The following table sets forth purchases in the market by the Company of shares of its common stock in its fourth fiscal quarter ended January 31, 2022.

Added

Our shares that are listed and traded on Upstream by our global stockholders would be uncertificated common stock represented by digital share tokens, that represent the same class and shares that are currently traded on the Nasdaq Stock Exchange.

Removed

Period (a) Total number of shares of common stock purchased (b) Average price paid per share (c) Total number of shares purchased as part of publicly announced plans of programs (d) Maximum number (or approximate dollar value) of shares that may yet to be purchased under the plans or programs December 2021 28, 125 $ 3.71 28,125 $ 895,000

Added

U.S. or Canada residents are not permitted to list their Nutriband shares on Upstream, which limits stockholder listings to non-residents of the U.S. and Canada. At present, a total of 250,000 shares of our common stock have been listed on Upstream by global holders.

Added

We have received comment letters from the SEC as to our disclosures in the Current Report on Form 8-K that we filed on January 5, 2023, announcing the dual listing, and expect that we will be filing further disclosures on the operation of the exchange and its rules regarding listing of Nutriband shares by our shareholders on that exchange.

Added

Unresolved Staff Comments.” in this Annual Report, as well as risk factors associated with the listing by Nutriband shareholders of their shares on that exchange set forth under “Risk Factors—Risks Concerning Our Securities”. 24 Sales of Unregistered Securities The following table sets forth the sales of unregistered securities since the Company’s last report filed under this item.

Added

Date Title and Amount (1) Purchaser Principal Underwriter Total Offering Price/ Underwriting Discounts May 10, 2022 1,667 shares of common stock Radu Bujoreanu, Director NA $ 3,800/NA May 10, 2022 1,667 shares of common stock Stefani Mancas, Director NA $ 3,800/NA May 10, 2022 1,667 shares of common stock Irina Gram, Director NA $ 3,800/NA May 10, 2022 1,667 shares of common stock Consultant NA $ 3,800/NA May 10, 2022 1,667 shares of common stock Mark Hamilton, Director NA $ 3,800/NA May 10, 2022 1,667 shares of common stock Michael Meyer NA $ 38,000/NA May 10, 2022 11,667 shares of common stock Gareth Sheridan, CEO NA $ 38,000/NA May 10, 2022 583 shares of common stock Employee NA $ 1,900/NA May 10, 2022 583 shares of common stock Employee NA $ 1,900/NA May 10, 2022 583 shares of common stock Employee NA $ 1,900/NA May 10, 2022 583 shares of common stock Employee NA $ 1,900/NA November 8, 2022 583 shares of common stock Employee NA $ 1,900/NA November 8, 2022 1,667 shares of common stock Consultant NA $ 19,000/NA November 8, 2022 5,833 shares of common stock Consultant NA $ 102,750/NA (1) The issuances to employees, consultants and investors are viewed by the Company as exempt from registration under the Securities Act of 1933, as amended (“Securities Act”), alternatively, as transactions either not involving any public offering, or as exempt under the provisions of Regulation D or Rule 701, promulgated by the SEC under the Securities Act.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

41 edited+34 added−22 removed17 unchanged

2022 filing

2023 filing

Biggest changeThe Company accounts for Other Intangible Assets under the guidance of ASC 350, “Intangibles-Goodwill and Other.” The Company capitalizes certain costs related to patent technology. A substantial component of the purchase price related to the Company’s acquisitions have also been assigned to intellectual property and other intangibles.

Biggest changeAs of January 31, 2023 and 2022, 100% of the inventory consists of raw materials. Intangible Assets Intangible assets include trademarks, intellectual property and customer base acquired through business combinations. The Company accounts for Other Intangible Assets under the guidance of ASC 350, “Intangibles-Goodwill and Other.” The Company capitalizes certain costs related to patent technology.

Trademarks, intellectual property and customer base are being amortized over their estimated useful lives of ten years. 37 Goodwill Goodwill represents the difference between the total purchase price and the fair value of assets (tangible and intangible) and liabilities at the date of acquisition.

Trademarks, intellectual property and customer base are being amortized over their estimated useful lives of ten years. Goodwill Goodwill represents the difference between the total purchase price and the fair value of assets (tangible and intangible) and liabilities at the date of acquisition.

For the year ended January 31, 2022, we had cash flows of $7,630,721 from financing activities, primarily $9.4 million from the completion of our public offering, exercise of warrants, and gross proceeds from the sale of common stock offset by a payment on long-term debt of $1.5 million and the repurchase of treasury stock.

For the year ended January 31, 2022, we had cash flows of $7,630,693 from financing activities, primarily $9.4 million from the completion of our public offering, exercise of warrants, and gross proceeds from the sale of common stock offset by a payment on long-term debt of $1.5 million and the repurchase of treasury stock.

We received on January 28, 2022 an Issue Notification from the United States Patent and Trademark Office (USPTO) for its United States patent entitled, “Abuse and Misuse Deterrent Transdermal System,” that protects our AVERSA™ transdermal abuse deterrent technology.

The Company bases its estimates on historical experience and on other various assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results could differ from those estimates.

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 abuse deterrent fentanyl transdermal system with the development of additional transdermal prescription products for pharmaceuticals that have risks or a history of abuse.

In addition, 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 abuse deterrent fentanyl transdermal system with the development of abuse deterrent transdermal products for pharmaceuticals that have risks or a history of abuse.

The underwriters’ over-allotment option was exercised for 158,400 warrants to purchase shares of common stock bringing to total net proceeds to the Company from the IPO to $5,836,230. The shares of common stock and Warrants are separately transferred immediately upon issuance.

The underwriters’ over-allotment option was exercised for 184,800 warrants to purchase shares of common stock bringing to total net proceeds to the Company from the IPO to $5,836,230. The shares of common stock and Warrants are separately transferred immediately upon issuance.

We are, for the near term, continuing this activity, although we do not anticipate that it will generate significant revenues and, since our acquisition, it has generated a negative gross margin. We have no long-term contractual obligations, and either party can terminate at any time. With the change in our focus, our capital requirements have increased substantially.

We are, for the near term, continuing this activity, although we do not anticipate that it will generate significant revenues and, since our acquisition, it has generated minor gross margins. We have no long-term contractual obligations, and either party can terminate at any time. 26 With the change in our focus, our capital requirements have increased substantially.

On October 5, 2021, the Company, having been approved for the listing of its common stock on The Nasdaq Capital Market effective October 1, 2021, consummated a public offering (the “IPO”) of units (the “Units”), of common stock and warrants that were offered in the IPO on The Nasdaq Capital Market, which included 1,056,000 (each a “Unit”), each Unit consisting of one share of common stock, par value $0.001 per share, and one warrant (each a “Warrant”) at a price of $6.25 per Unit.

On October 5, 2021, the Company, having been approved for the listing of its common stock on The Nasdaq Capital Market effective October 1, 2021, consummated a public offering (the “IPO”) of units (the “Units”), of common stock and warrants that were offered in the IPO on The Nasdaq Capital Market, which included 1,231,200 (each a “Unit”), each Unit consisting of one share of common stock, par value $0.001 per share, and one warrant (each a “Warrant”) at a price of $5.36 per Unit.

Each Warrant is immediately exercisable, will entitle the holder to purchase one share of common stock at an exercise price of $7.50 and will expire five (5) years from the date of issuance.

Each Warrant is immediately exercisable, will entitle the holder to purchase one share of common stock at an exercise price of $6.43 and will expire five (5) years from the date of issuance.

The Company received proceeds of approximately $8.8 million from the completion of its public offering, exercise of warrants and the sale of common stock during the year ended January 31, 2022. For the year ended January 31, 2022, we used cash of $2,809,223 in our operations.

In connection with the Company’s acquisition of 4P Therapeutics LLC in 2018, the Company recorded Goodwill of $1,719,235. On August 31, 2020, in connection with the Company’s acquisition of PCP Assets and Active Intelligence , the Company recorded Goodwill of $5,810,640.

In connection with the Company’s acquisition of 4P Therapeutics LLC in 2018, the Company recorded Goodwill of $1,719,235. On August 31, 2020, in connection with the Company’s acquisition of Pocono Coated Products LLC and Active Intelligence LLC, the Company recorded Goodwill of $5,810,640.

During the year ended January 31, 2022, the Company recorded an impairment expense of $2,180,836 due to a write down of Goodwill in connection with its Pocono acquisition. The write down of goodwill is attributable primarily to the effects of the pandemic.

During the years ended January 31, 2023 and 2022, the Company recorded an impairment expense of $327,326 and $2,180,836, respectively, due to a write down of Goodwill in connection with its Pocono acquisition. The write down of goodwill is attributable primarily to the effects of the pandemic.

We have budgeted $5.0 million for research and development of our abuse deterrent fentanyl transdermal system, including clinical manufacturing and clinical trials that need to be completed in order to obtain FDA approval. However, the total cost could be substantially in excess of that amount.

We will require approximately $13 million for research and development of our abuse deterrent fentanyl transdermal system, including clinical manufacturing and clinical trials that need to be completed in order to obtain FDA approval. However, the total cost could be substantially in excess of that amount.

With our acquisition of 4P Therapeutics on August 1, 2018, our focus changed, and we are seeking to develop and seek FDA approval on a number of transdermal pharmaceutical products under development by 4P Therapeutics.

Following our acquisition of 4P Therapeutics on August 1, 2018, our focus expanded to include prescription pharmaceuticals, and we are seeking to develop and seek FDA approval on a number of transdermal pharmaceutical products under development by 4P Therapeutics.

Consumer products are products that are sold over the counter and do not require a prescription. Most of our consumer products require FDA approval for sale in the United States, and we have not sought to obtain, and we do not plan to seek to obtain, FDA approval to market these products in the United States at this time.

Most of our planned consumer products require FDA approval for sale in the United States, and we have not sought to obtain, and we do not plan to seek to obtain, FDA approval to market these products in the United States at this time.

The measures being taken by service providers and government agencies to suppress the spread of COVID-19 infection may delay time to production of our planned abuse deterrent fentanyl transdermal system product and therefor delay the time of filing with FDA for approval. Overview Our primary business is the development of a portfolio of transdermal pharmaceutical products.

As of January 3, 2022, 392,396 Warrants issued in the IPO have been exercised, with net proceeds to the Company of $2,942,970. On November 1, 2021, The Board of Directors adopted the 2021 Employee Stock Option Plan (the “Plan”). The Company has reserved 350,000 shares to issue and sell upon the exercise of stock options issued under the Plan.

As of October 31, 2022, 457,795 Warrants issued in the IPO have been exercised, with net proceeds to the Company of $2,942,970. On November 1, 2021, The Board of Directors adopted the 2021 Employee Stock Option Plan (the “Plan”). The Company has reserved 408,333 shares to issue and sell upon the exercise of stock options issued under the Plan.

Years Ended January 31, 2022 and 2021 For the year ended January 31, 2022, we generated revenue of $1,422,154 and our costs of revenue were $917,844, resulting in a gross margin of $504,310. For the year ended January 31, 2021, we generated revenue of $943,702 and our costs of revenue were $627,378, resulting in a gross margin of $316,324.

For the year ended January 31, 2022, we generated revenue of $1,422,154 and our costs of revenue were $917,844, resulting in a gross margin of $504,310 in the subsequent year.

Earnings per Share Basic earnings per share of common stock is computed by dividing net earnings by the weighted average number of shares of common stock outstanding during the period. Diluted earnings per share is computed by dividing net earnings by the weighted average number of shares of common stock and potential shares of common stock outstanding during the period.

Diluted earnings per share is computed by dividing net earnings by the weighted average number of shares of common stock and potential shares of common stock outstanding during the period. Potential shares of common stock consist of shares issuable upon the exercise of outstanding options and common stock purchase warrants.

On January 21, 2022, the Board approved options to purchase 163,500 shares of the Company’s common stock issued to executive officers and directors of the Company at a price of $4.85 ($5.34 per share for two of the officers as required by IRS rules).

On January 21, 2022, the Board approved options to purchase 190,751 shares of the Company’s common stock under the Plan issued to executive officers and directors of the Company at an exercise price of $4.16 ($4.58 per share for two of the officers as required by IRS rules).

As a result of the foregoing, we sustained a net loss of $6,372,715, or $(0.94) per share (basic and diluted) for the year ended January 31, 2022, compared with a loss of $2,932,828, or $(0.51) per share (basic and diluted) for the year ended January 31, 2021.

As a result of the foregoing, we sustained a net loss of $4,483,474, or $(0.53) per share (basic and diluted) for the year ended January 31, 2023, compared with a loss of $6,372,715, or $(0.80) per share (basic and diluted) for the year ended January 31, 2022.

On November 3, 2021, the Company filed a Registration Statement on Form S-8, to register under the Securities Act of 1933, as amended, the 350,000 shares of common stock reserved for issuance under the Plan.

On November 3, 2021, the Company filed a Registration Statement on Form S-8, to register under the Securities Act of 1933, as amended, the 408,333 shares of common stock reserved for issuance under the Plan, and on October 12, 2022, a Post-Effective Amendment to the Form S-8 was filed with the SEC.

The transaction was completed at a closing on February 26, 2021. On August 31, 2020, the Company entered into a Purchase Agreement (“Agreement”), with Pocono Coated Products (“PCP”), pursuant to which PCP agreed to sell the Company all of the assets associated with its Transdermal, Topical, Cosmetic and Nutraceutical business (the “Assets”).

On August 31, 2020, the Company entered into a Purchase Agreement (“Agreement”), with Pocono Coated Products (“PCP”), pursuant to which PCP agreed to sell the Company all of the assets associated with its Transdermal, Topical, Cosmetic and Nutraceutical business (the “Assets”). PCP is the manufacturer of our transdermal consumer products, and we bought that business from them.

Our lead product is our abuse deterrent fentanyl transdermal system which we are developing to provide clinicians and patients with an extended-release transdermal fentanyl product for use in managing chronic pain requiring around the clock opioid therapy combined with properties designed to help combat the opioid crisis by deterring the abuse and misuse of fentanyl patches.

Our abuse deterrent transdermal product under development has the potential to provide clinicians and patients with an extended-release transdermal fentanyl product for use in managing chronic pain requiring around the clock opioid therapy combined with properties designed to deter the abuse and misuse of fentanyl patches.

ASU 2014-09 is based on principles that govern the recognition of revenue at an amount an entity expects to be entitled when products are transferred to a customer. We adopted the guidance under the new revenue standards using the modified retrospective method effective February 1, 2018.

ASU 2014-09 is based on principles that govern the recognition of revenue at an amount an entity expects to be entitled when products are transferred to a customer.

The carrying amount of a long-lived asset is not recoverable if it exceeds the sum of the estimated undiscounted cash flows expected to result from the use and eventual disposition of the asset. If an impairment exists, the resulting write-down would be the difference between the fair market value of the long-lived asset and the related book value.

The carrying amount of a long-lived asset is not recoverable if it exceeds the sum of the estimated undiscounted cash flows expected to result from the use and eventual disposition of the asset.

Potential shares of common stock consist of shares issuable upon the exercise of outstanding options and common stock purchase warrants. As of January 31, 2022, and 2021, there were 1,288,432 and 141,830 common stock equivalents outstanding, that were not included in the calculation of dilutive earnings per share as their effect would be anti-dilutive.

As of January 31, 2023, and 2022, there were 1,778,006 and 1,503,171 common stock equivalents outstanding, that were not included in the calculation of dilutive earnings per share as their effect would be anti-dilutive.

Following our acquisition of Pocono, our focus is primarily now on providing contract manufacturing services and consulting services to 3 rd party brands with no intention at this time to launch our own consumer products.

Following our acquisition of selected assets from Pocono Coated Products, LLC (“Pocono”), we are primarily focused on providing contract manufacturing services and consulting services to 3 rd party brands with no intention at this time to launch our own consumer products. 4P Therapeutics has not generated any revenue from any of its products under development.

During the year ended January 31, 2022, the Company incurred a gain on extinguishment of debt of $53,028, consisting primarily of forgiveness of a PPP loan. We incurred interest expense of $118,421, primarily from the amortization of debt discounts for the Year ended January 31, 2022, as compared to $280,686 for the year ended January 31, 2021.

We incurred interest expense of $8,289 for the year ended January 31, 2023, as compared to $118,421 for the year ended January 31, 2022, primarily from the amortization of debt discounts.

Under the guidance, other intangible assets with definite lives are amortized over their estimated useful lives. Intangible assets with indefinite lives are tested annually for impairment.

A substantial component of the purchase price related to the Company’s acquisitions have also been assigned to intellectual property and other intangibles. Under the guidance, other intangible assets with definite lives are amortized over their estimated useful lives. Intangible assets with indefinite lives are tested annually for impairment.

If we are not able to continue to obtain financing or enter into a joint venture agreement, we may not be able to continue in business. 33 Through July 31, 2018, our business was the development of a line of consumer and health products that are delivered through a transdermal or topical patch.

Transdermal Pharmaceutical Products Through October 31, 2018, our business was the development of a line of consumer and health products that are delivered through a transdermal or topical patch.

The plans enable the Company to meet its obligations for at least one year from the date when the financial statements are issued. Revenue Recognition In May 2014, the FASB issued ASU No. 2014-09, “Revenue from Contracts with Customers (Topic 606) (“ASU 2014-09”), which amends the accounting standards for revenue recognition.

Actual results could differ from those estimates. 29 Revenue Recognition In May 2014, the FASB issued ASU No. 2014-09, “Revenue from Contracts with Customers (Topic 606) (“ASU 2014-09”), which amends the accounting standards for revenue recognition.

Off Balance Sheet Arrangements We have no off-balance sheet arrangements that have or are reasonably likely to have a current or future material effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources. 36 Critical Accounting Policies Going Concern As of January 31, 2022, the Company believes the substantial doubt about its status as a going concern has been resolved.

Off Balance Sheet Arrangements We have no off-balance sheet arrangements that have or are reasonably likely to have a current or future material effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources. 28 Critical Accounting Policies Forward Stock Split On July 26, 2022, our Board of Directors approved the amendment to our Articles of Incorporation to effect a 7 for 6 forward stock split (the “Stock Split”) of our outstanding common stock.

As of February 1, 2019, pursuant to ASC 2018-07, ASC 718 was applied to stock-based compensation for both employees and non-employees.

As of February 1, 2019, pursuant to ASC 2018-07, ASC 718 was applied to stock-based compensation for both employees and non-employees. Research and Development Expenses Research and development costs are expensed as incurred. Income Taxes Taxes are calculated in accordance with taxation principles currently effective in the United States and Ireland.

Liquidity and Capital Resources As of January 31, 2022, we had $4,891,868 in cash and cash equivalents and working capital of $4,686,112, as compared with cash and cash equivalents of $151,993 and working capital deficiency of $2,254,418 as of January 31, 2021.

The net loss for 2022 includes a deemed dividend of $196,589 from the settlement of a warrant round down. Liquidity and Capital Resources As of January 31, 2023, we had $1,985,440 in cash and cash equivalents and working capital of $1,945,132, as compared with cash and cash equivalents of $4,891,868 and working capital of $4,686,112 as of January 31, 2022.

Since we do not have the funds for development of our lead product, the 4P Therapeutics fixed costs are allocated to the contract services that we perform for clients. Our cost of revenue for our contract research and development services represents basically our labor cost plus a modest amount of material costs which we passed on to the client.

The transdermal patch manufacturing segment increased its margin by 3% during the period. Our cost of revenue for our contract research and development services represents our labor cost plus a modest amount of material costs which we passed on to the client. Our sales and cost of sales remained constant for our contract services compared to the prior year.

For the years ended January 31, 2022 and 2021, the Company recorded no bad debt expense for doubtful accounts related to account receivable. Intangible Assets Intangible assets include trademarks, intellectual property and customer base acquired through business combinations.

For the years ended January 31, 2023 and 2022, the Company recorded no bad debt expense for doubtful accounts related to account receivable. Inventories Inventories are valued at the lower of cost and reasonable value determined using the first-in, first-out (FIFO) method.

During the year ended January 31, 2022, the Company recorded an impairment charge of $2,180,836 reducing the PCP Assets and Active Intelligence goodwill to $3,629,813. The write down of goodwill is attributable primarily to the effect of the pandemic. Covid-19, unmet sales expectations, and other factors the Company determined resulted in the impairment.

During the years ended January 31, 2023 and 2022, the Company recorded an impairment charge of $327,326 and $2,180,836, respectively, reducing the Active Intelligence LLC Goodwill to $3,302,478. As of January 31, 2023 and 2022, Goodwill amounted to $5,021,713 and $5,349,039, respectively.

The Company moved from the 4P facilities, and many of the prior costs relating to the facility were not incurred. 35 For the year ended January 31, 2022, our selling, general and administrative expenses were $4,022,824, primarily legal, accounting, administrative salaries and non-cash expenses of $1,364,732, compared to $2,912,269 for the year ended January 31, 2021.The increase from 2021 is primarily attributable to non-cash consulting expenses of $1,364,732, and the inclusion of expenses of $668,661 of Active Intelligence in 2022.

For the year ended January 31, 2023, our selling, general and administrative expenses were $3,916,041, primarily legal, accounting, administrative salaries and equity-based payments, compared to $4,022,824 for the year ended January 31, 2022. The amount remained relatively constant for the prior year.

During the year January 31, 2022, the Company commenced research and development expenses on its Aversa product and incurred $144,000 of salary liabilities that were paid with the issuance of common stock and other expenses of $267,303.

During the year January 31, 2023, the Company incurred research and development expenses on its Aversa Fentanyl product of $982,227, primarily of salaries and development costs from Kindeva as compared to $411,383 for the year ended January 31, 2022.

Removed

In addition, we are developing a portfolio of transdermal pharmaceutical products to deliver commercially available drugs or biologics that are typically delivered by injection but with the potential to improve compliance and therapeutic outcomes. We are proceeding with our development efforts with respect to these products and to performing contract services for a small number of customers.

Added

Our primary business is the development of a portfolio of transdermal pharmaceutical products. Our lead product is our abuse deterrent fentanyl transdermal system which will require approval from the Food and Drug Administration (“FDA”) and substantial additional capital for research and development.

Removed

Because of both our financial position and the effects of the COVID-19 pandemic, our contract service business has also been scaled back.

Added

On August 1, 2022, the Board approved option grants previously approved by the Compensation Committee for an aggregate of 137,084 shares of common stock at exercise prices $4.09 or $4.50 per share depending on IRS rules as applicable to the recipient,, and on September 30, 2022, approved option issuances under the Plan for an aggregate of 35,000 shares of common stock at an exercise price of $3.59 per share for services provided by the independent directors, as previously approved by the Compensation Committee.

Removed

The description of our business in this annual report is based on our ability to raise significant financing or enter into a joint venture agreement with a third party that has the financial ability to fund the joint venture’s operations.

Added

The Company received a favorable verdict on July 13, 2022 from the Circuit Court, Orange County, Florida, providing for rescission of the Company’s 2017 acquisition of Advanced Health Brands and recovery by the Company of the 1,400,000 shares(adjusted for a 1-for-4 reverse stock split effective June 23, 2019 and the 7-for-six forward stock split effective August 15, 2022) of common stock issued in the acquisition, effectively allowing the Company on July 25, 2022 to cancel 1.4M shares of common stock held by the defendants.

Removed

We cannot assure you that we will be able to obtain necessary financing or enter into a joint venture agreement on reasonable, if any, terms.

Added

On October 31, 2022, the Company filed the Proxy Statement with the SEC for its Annual Meeting of Stockholders, to be held December 9, 2022, in Orlando, Florida. This Proxy Statement is available on our website at HTTPS://Nutriband.com/proxy . Forward Split of our Common Stock.

Removed

As a result of the acquisition of 4P Therapeutics, we have pipeline of potential products. 4P Therapeutics has not generated any revenue from any of its products under development.

Added

On July 26, 2022, our Board of Directors approved the amendment to our Articles of Incorporation to effect a 7 for 6 forward stock split (the “Stock Split”) of our outstanding common stock. We filed the amendment set forth in a Certificate of Change with the Secretary of State of Nevada on August 4, 2022.

Removed

On March 25, 2020, we completed a private placement of 46,828 units at a price of $11 per unit. Each unit consisted of one share of common stock and a warrant to purchase one share of common stock at an exercise price of $14 per share. The warrants expire April 30, 2023.

Added

The 7:6 forward split was effective for trading purposes on the Nasdaq Capital Market on August 12, 2022. Each shareholder of record as of the August 15, 2022 record date received one (1) additional share of common stock for each six (6) shares held as of the record date.

Removed

We issued a total of 46,828 shares of common stock and warrants to purchase 46,828 shares of common stock. We received proceeds of $515,113. On March 25, 2020, w e paid off the convertible notes in the principal amount of $270,000 from the proceeds of the private placement. The total payments, including the prepayment penalty and accrued interest, was $345,656.

Added

No fractional shares of common stock were issued in connection with the Stock Split. Instead, all shares were rounded up to the next whole share.

Removed

The payment was made from the proceeds of the private placement. As a result of the payment of the notes, the derivative liability, which was $928,774 at July 31, 2020, was reduced to zero.

Added

In connection with the Stock Split, which did not require shareholder approval under the Nevada corporation law, the number of authorized shares of common stock of the Company was increased in the same ratio as the shares of outstanding common stock were increased in the Stock Split, from 250,000,000 authorized shares to 291,666,666 authorized shares. 27 Years Ended January 31, 2023 and 2022 For the year ended January 31, 2023, we generated revenue of $2,079,609 and our costs of revenue were $1,329,200, resulting in a gross margin of $750,409.

Removed

As a result of a completed private placement, the warrants to purchase 50,000 shares at the lesser of (i) $20.90 or, (ii) if the Company completes its public offering of its common stock, 110% of the initial public offering price of the Common Stock in the public offering, became a warrant to purchase 95,000 warrants at $11 per share, subject to adjustment pursuant to the antidilution provisions of the warrant.

Added

Our revenue for the year ended January 31, 2023, was derived from sales of $1,785,507 from our transdermal patch manufacturing segment and $294,102 from contract services from our 4P Therapeutics segment. The increase in revenue of $657,455 from the transdermal patch manufacturing segment is primarily due to an increase in demand which has continued in the subsequent year.

Removed

The Company recorded a derivative liability for the warrants in the amount of $906,678 and reclassed the derivative liability to additional paid-in capital as of January 31, 2021. 34 In March 2020, a minority stockholder who had previously made loans to us in the total amount of $215,00, made an additional loan to us in the amount of $60,000, increasing the total loans from the stockholder to $275,000.

Added

During the year ended January 31, 2022, the Company incurred a gain on extinguishment of debt of $53,028, consisting primarily of forgiveness of a PPP loan. There was no gain on extinguishment of debt during the year ended January 31, 2023.

Removed

On March 27, 2020, we issued 25,000 shares of common stock upon conversion of the notes. Pursuant to a Stock Purchase Agreement (“SPA”), dated December 7, 2020, with the Company, BPM Inno Ltd., Kiryat, Israel, purchased 81,396 shares of common stock at a price of $8.60 per share, or $700,000, which provided payment for the RamBam license.

Added

The principal adjustments to our net loss of $4,483,474 were depreciation and amortization of $330,143, and stock-based compensation of $1,019,310, and goodwill impairment of $327,326. For the year ended January 31, 2023, we used cash in investing activities of $79,304 primarily for the purchase of equipment.

Removed

PCP is the manufacturer of our transdermal products, and we bought that business from them.

Added

For the year ended January 31, 2023, we provided cash in financing activities of $160,074, primarily from the proceeds of $296,875 from the exercise of warrants, offset from the purchase of treasury stock of $119,006.

Removed

Our revenue for January 31, 2022 was derived from three sources – (1) a continuation of research and development contracts of the type 4P Therapeutics performed prior to our acquisition, which accounted for $242,354, (2) sales of our consumer transdermal product to or South Korean distributor, which accounted for $86,600 which our distributor purchased for its preliminary marketing efforts since the product has not obtained regulatory approval for retail sales in South Korea and (3) sales from our recent acquisition of transdermal patches, which accounted for $1,093,200.

Added

The Company filed the amendment set forth in a Certificate of Change with the Secretary of State of Nevada on August 4, 2022. The 7:6 forward stock split was effective for trading purposes on the Nasdaq Capital Market on August 12, 2022.

Removed

During the year ended January 31, 2021, we incurred gain on change in fair value of derivatives of $22,096 in connection with our October 2019 financing in which we raised gross proceeds of $250,000 and net proceeds of approximately $230,000 from the sale of convertible notes and warrants.

Added

Each shareholder of record as of the August 15, 2022 record date received one (1) additional share for each six (6) shares held as of the record date. No fractional shares of common stock were issued in connection with the Stock Split. Instead, all shares were rounded up to the next whole share.

Removed

The net loss for 2022 includes a deemed dividend of $196,589 from the settlement of a warrant round down.

Added

In connection with the Stock Split, which did not require shareholder approval under the Nevada corporation law, the number of shares of common stock of the Company was increased in the same ratio as the shares of outstanding common stock were increased in the Stock Split, from 250,000,000 authorized shares to 291,666,666 authorized shares.

Removed

The principal adjustments to our net loss of $6,176,126 were amortization of debt discount of $97,477, depreciation and amortization of $308,741, and stock-based compensation of $1,314,401, and goodwill impairment of $2,180,836, offset by a gain on extinguishment of debt of $53,028.

Added

All share and per share information in these financial statements retroactively reflect the forward stock split.

Removed

For the year ended January 31, 2022, we used cash in investing activities of $81,595 primarily for the purchase of equipment. During the year ended January 31, 2021, cash received from acquisition amounted to $66,964.

Added

Going Concern Assessment Management assesses liquidity and going concern uncertainty in the Company’s condensed financial statements to determine whether there is sufficient cash on hand and working capital, including available borrowings on loans, to operate for a period of at least one year from the date the consolidated financial statements are issued or available to be issued, which is referred to as the “look-forward period”, as defined in GAAP.

Removed

The going concern conditions that caused substantial doubt no longer exist as the Company has positive cash flow during the year ended and as of January 31, 2022 and has positive working capital as of January 31, 2022. In October 2021, the Company consummated a public offering and received net proceeds of $5,836,230.

Added

As part of this assessment, based on conditions that are known and reasonably knowable to management, management will consider various scenarios, forecasts, projections, estimates and will make certain key assumptions, including timing and nature of projected cash expenditures or programs, its ability to delay or curtail expenditures or programs and its ability to raise additional capital, if necessary, among other factors.

Removed

The Company also received $2,942,970 of proceeds from the exercise of warrants. Management retired most of its debt and other current obligations. Management has implemented other plans to alleviate the substantial doubt. These plans include a substantial increase in projected sales commitments. These factors did not exist in prior years during its start-up operations.

Added

Based on this assessment, as necessary or applicable, management makes certain assumptions around implementing curtailments or delays in the nature and timing of programs and expenditures to the extent it deems probable those implementations can be achieved and management has the proper authority to execute them within the look-forward period.

Removed

The Company’s recent history of losses has continued but future positive cash flow projections due to its management’s plans which includes its acquisition in the latter part of 2020 will enable the Company to alleviate the substantial doubt about the Company’s ability to continue as a going concern. Management’s plans have been currently implemented.

… 17 more changes not shown on this page.

Top changes in NutriBand Inc.'s 2023 10-K

Item 1. Business

Item 1A. Risk Factors

Item 2. Properties

Item 4. Mine Safety Disclosures

Item 5. Market for Registrant's Common Equity

Item 7. Management's Discussion & Analysis

Other NTRB 10-K year-over-year comparisons