Revenue Performance - For the three months ended October 31, 2023, revenue was $427,841, a decrease of 30.7% compared to $618,003 for the same period in 2022[11]. - For the nine months ended October 31, 2023, revenue was $1,560,701, slightly up by 0.6% from $1,552,074 in the prior year[11]. - Total revenue for the nine months ended October 31, 2023, was $1,560,701, compared to $1,552,074 for the same period in 2022, representing a growth of 0.1%[48]. - Revenue from the sale of goods was $1,395,667 for the nine months ended October 31, 2023, an increase from $1,325,127 in the prior year, while service revenues decreased to $165,034 from $226,947[48]. - For the three months ended October 31, 2023, the company generated revenue of $427,841, a decrease of 30.7% from $618,003 in the same period of 2022[143]. - For the nine months ended October 31, 2023, the company generated revenue of $1,560,701, a slight increase from $1,552,074 in the same period of 2022[147]. Expenses and Losses - Total costs and expenses for the three months ended October 31, 2023, were $2,151,352, an increase of 27.3% from $1,689,522 in the same period of 2022[11]. - The net loss for the three months ended October 31, 2023, was $1,759,946, compared to a net loss of $1,075,485 for the same period in 2022, representing an increase of 63.7%[11]. - For the nine months ended October 31, 2023, the company reported a net loss of $3,604,348, compared to a net loss of $2,804,149 for the same period in 2022, representing an increase in losses of approximately 28.5%[17]. - The company incurred a loss from operations of $3,565,577 for the nine months ended October 31, 2023, highlighting ongoing operational challenges[34]. - Selling, general and administrative expenses for the nine months ended October 31, 2023, were $2,849,399, an increase from $2,726,256 in the same period of 2022[148]. - Research and development expenses for the three months ended October 31, 2023, were $551,503, up 89.8% from $290,718 in the same period of 2022[11]. - Research and development expenses for the nine months ended October 31, 2023, increased significantly to $1,397,055 from $686,401 in the previous year, marking a 103.5% increase[97]. Cash and Assets - Cash and cash equivalents decreased to $1,265,323 as of October 31, 2023, from $1,985,440 as of January 31, 2023, a decline of 36.2%[10]. - Total assets as of October 31, 2023, were $8,523,076, down 10.0% from $9,456,377 as of January 31, 2023[10]. - The company reported a working capital of $1,281,963 as of October 31, 2023, indicating a need for careful cash management moving forward[34]. - As of October 31, 2023, total inventory was valued at $174,641, down from $229,335 as of January 31, 2023, indicating a reduction of approximately 23.8%[50]. - Net property and equipment as of October 31, 2023, was $766,839, a decrease from $897,735 as of January 31, 2023, showing a decline of approximately 14.5%[69]. - As of October 31, 2023, net intangible assets amounted to $695,568, down from $780,430 as of January 31, 2023, with accumulated amortization increasing from $351,070 to $435,932[76]. Liabilities and Debt - Total liabilities increased significantly to $2,811,738 as of October 31, 2023, compared to $883,387 as of January 31, 2023[10]. - Interest expenses for the nine months ended October 31, 2023, totaled $52,601, compared to $12,505 for the same period in 2022, indicating a significant increase[74]. - The company entered into a three-year credit line facility for $5,000,000 on July 13, 2023, increasing from a previous facility of $2,000,000[152]. - The company recorded interest expense of $42,012 for the nine months ended October 31, 2023, related to the Credit Line Note with TII Jet Services LDA[72]. Legal and Regulatory Matters - The Company is facing a legal complaint seeking damages exceeding $500,000 due to the termination of an engagement letter for a public offering of common stock[115]. - The Company has counterclaimed for damages of $1,000,000 on multiple counts, including intentional interference with prospective economic advantage and breach of contract[117]. - The Company believes that any potential loss from the ongoing legal proceedings will not materially affect its consolidated financial position or operations[120]. - The Company has not accrued any amount for possible loss as of October 31, 2023[120]. - The company has identified material weaknesses in its internal controls, including a lack of qualified accounting personnel and excessive reliance on third-party consultants[178]. - The company has added qualified accounting personnel to reduce reliance on third-party consultants and has established additional monitoring controls over financial statements[178]. Future Outlook and Development - Management believes that sufficient funds will be generated from operations to support the company for at least one year from the date of the financial statements, indicating a positive outlook despite current losses[35]. - The company expects to continue incurring substantial losses and negative cash flow for the foreseeable future due to ongoing product development and clinical trials[193]. - The Company estimates it will require approximately $13 million for research and development of its abuse deterrent fentanyl transdermal system, including clinical trials[134]. - The company is currently facing a lawsuit claiming damages exceeding $500,000 related to the termination of an engagement letter for a public offering of its common stock[186]. - The company has not generated any revenue from its products under development since the acquisition of 4P Therapeutics, which previously generated minor gross margins[132]. Stock and Equity - The weighted average shares of common stock outstanding for the three months ended October 31, 2023, were 7,833,150, compared to 7,803,264 for the same period in 2022[11]. - As of October 31, 2023, the total outstanding stock options were 874,835, with an average exercise price of $3.23 and an intrinsic value of $86,840[95]. - The company has reserved 408,333 shares for its 2021 Employee Stock Option Plan, with additional shares reserved in subsequent years[137]. - The company recorded a non-cash compensation of $242,840 for warrants issued during the nine months ended October 31, 2023[86]. - During the nine months ended October 31, 2023, 404,500 options were issued to executive officers and employees at prices ranging from $1.93 to $3.975 per share, with a total fair value of $499,856[92]. Compliance and Reporting - The company has filed various certifications including Section 302 and Section 906 by the CEO and CFO, ensuring compliance with regulatory requirements[201][202]. - The report includes Inline XBRL documents for detailed financial data presentation, enhancing transparency and accessibility of financial information[200]. - The company is committed to maintaining accurate financial reporting through the certifications provided by its principal executive and financial officers[202].

[PART I. FINANCIAL INFORMATION](index=4&type=section&id=Part%20I%3A%20Financial%20Information) [ITEM 1. FINANCIAL STATEMENTS](index=4&type=section&id=Item%201%20Financial%20Statements) The unaudited condensed consolidated financial statements detail the company's financial position, performance, and cash flows [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets grew to $9.87 million, driven by increased cash and a significant rise in related-party notes payable Key Balance Sheet Metrics | Metric | July 31, 2023 (Unaudited) | January 31, 2023 | | :-------------------------------- | :-------------------------- | :----------------- | | Cash and cash equivalents | $2,334,553 | $1,985,440 | | Total Current Assets | $3,273,573 | $2,693,745 | | Total Assets | $9,872,628 | $9,456,377 | | Total Current Liabilities | $874,127 | $748,613 | | Note payable-related party | $2,000,000 | $- | | Total Liabilities | $2,981,920 | $883,387 | | Total Stockholders' Equity | $6,890,708 | $8,572,990 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Revenue increased for the three and six-month periods, though higher R&D expenses drove a larger net loss for the six-month period Key Operations Metrics | Metric | 3 Months Ended July 31, 2023 | 3 Months Ended July 31, 2022 | 6 Months Ended July 31, 2023 | 6 Months Ended July 31, 2022 | | :----------------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Revenue | $655,928 | $456,149 | $1,132,860 | $934,071 | | Cost of revenues | $356,256 | $304,353 | $610,904 | $581,789 | | Research and development | $445,122 | $277,869 | $845,552 | $395,683 | | Selling, general and administrative | $678,738 | $908,173 | $1,518,470 | $1,676,724 | | Loss from operations | $(824,188) | $(1,034,246) | $(1,842,066) | $(1,720,125) | | Net loss | $(829,173) | $(1,038,675) | $(1,844,402) | $(1,728,664) | | Net loss per share (basic and diluted) | $(0.11) | $(0.12) | $(0.24) | $(0.20) | [Consolidated Statements of Stockholders' Equity](index=7&type=section&id=Consolidated%20Statements%20of%20Stockholders'%20Equity) Stockholders' equity decreased to $6.89 million from $8.57 million due to the net loss incurred during the six-month period Changes in Stockholders' Equity | Metric | February 1, 2023 | July 31, 2023 | | :-------------------------------- | :--------------- | :-------------- | | Total Stockholders' Equity | $8,572,990 | $6,890,708 | | Net loss for the six months | - | $(1,844,402) | | Warrants issued for services | - | $87,090 | | Options issued for services | - | $75,030 | [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) A significant cash inflow from financing activities offset cash used in operations, resulting in an overall increase in cash Summary of Cash Flows | Cash Flow Activity | 6 Months Ended July 31, 2023 | 6 Months Ended July 31, 2022 | | :----------------------------------- | :--------------------------- | :--------------------------- | | Net Cash Used In Operating Activities | $(1,744,999) | $(1,652,750) | | Net Cash Used in Investing Activities | $(2,624) | $(68,009) | | Net Cash Provided by Financing Activities | $2,096,736 | $173,449 | | Net change in cash | $349,113 | $(1,547,310) | | Cash and cash equivalents - End of period | $2,334,553 | $3,344,558 | [Notes to Unaudited Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) These notes provide detailed disclosures on the company's business, accounting policies, and specific financial statement line items [1. ORGANIZATION AND DESCRIPTION OF BUSINESS](index=11&type=section&id=1.%20ORGANIZATION%20AND%20DESCRIPTION%20OF%20BUSINESS) The company focuses on developing transdermal pharmaceutical products through strategic acquisitions like 4P Therapeutics and Pocono Pharmaceuticals - Nutriband Inc. acquired 4P Therapeutics in 2018, shifting its principal business to the development of **transdermal pharmaceutical products**, including abuse-deterrent systems[25](index=25&type=chunk)[27](index=27&type=chunk) - In 2020, the company expanded into **coated product manufacturing** and **activated kinesiology tape** through acquisitions[28](index=28&type=chunk)[29](index=29&type=chunk) - The company's lead product, **AVERSA™** transdermal abuse deterrent technology, is in the preclinical stage and requires **FDA approval**[26](index=26&type=chunk)[27](index=27&type=chunk) [2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES](index=12&type=section&id=2.%20SUMMARY%20OF%20SIGNIFICANT%20ACCOUNTING%20POLICIES) Key accounting policies cover the going concern assessment, revenue recognition, and valuation of assets like goodwill and intangibles - The company's financial statements are unaudited and prepared in accordance with **U.S. GAAP**, with no significant changes to accounting policies during the six months ended July 31, 2023[31](index=31&type=chunk)[33](index=33&type=chunk) - A **7-for-6 forward stock split** was effective on August 12, 2022, increasing authorized common shares from 250,000,000 to 291,666,666[34](index=34&type=chunk) - Management believes the company can continue as a **going concern** for at least one year, supported by **$2,334,553 in cash** and a **$5,000,000 credit line facility**, despite historical operating losses[37](index=37&type=chunk)[38](index=38&type=chunk)[39](index=39&type=chunk) - Revenue is recognized based on five criteria under **Topic 606**, with performance obligations satisfied either upon product shipment or over time[43](index=43&type=chunk)[46](index=46&type=chunk)[48](index=48&type=chunk) Revenue by Type | Revenue Type | 6 Months Ended July 31, 2023 | 6 Months Ended July 31, 2022 | 3 Months Ended July 31, 2023 | 3 Months Ended July 31, 2022 | | :------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Sale of goods | $967,826 | $796,894 | $566,769 | $394,904 | | Services | $165,034 | $137,177 | $89,159 | $61,245 | | Total Revenue | $1,132,860 | $934,071 | $655,928 | $456,149 | - Goodwill amounted to **$5,021,713** as of July 31, 2023, with prior impairment charges related to the Active Intelligence LLC acquisition[56](index=56&type=chunk) [3. PROPERTY AND EQUIPMENT](index=20&type=section&id=3.%20PROPERTY%20AND%20EQUIPMENT) Net property and equipment decreased to $806,423 due to accumulated depreciation, with a portion allocated to cost of goods sold Property and Equipment, Net | Asset Category | July 31, 2023 | January 31, 2023 | | :----------------------- | :------------ | :--------------- | | Lab equipment | $144,585 | $144,585 | | Machinery and equipment | $1,243,252 | $1,240,628 | | Furniture and fixtures | $19,643 | $19,643 | | Total Cost | $1,407,480 | $1,404,856 | | Less: Accumulated depreciation | $(601,057) | $(507,121) | | Net Property and Equipment | $806,423 | $897,735 | - Depreciation expenses for the six months ended July 31, 2023, were **$93,936**, with **$72,445** allocated to cost of goods sold[73](index=73&type=chunk) [4. NOTES PAYABLE](index=22&type=section&id=4.%20NOTES%20PAYABLE) The company utilized a related-party line of credit and a secured borrowing liability, contributing to increased interest expenses - A **$5,000,000 credit line facility** with a related party was amended on July 17, 2023, with **$2,000,000** advanced as of July 31, 2023[77](index=77&type=chunk) - A secured borrowing liability of **$106,528** was recorded from the assignment of a bankruptcy claim, with a corresponding bad debt expense of **$11,836**[78](index=78&type=chunk) Interest Expense | Metric | 6 Months Ended July 31, 2023 | 6 Months Ended July 31, 2022 | | :------------- | :--------------------------- | :--------------------------- | | Interest expense | $12,401 | $8,539 | [5. INTANGIBLE ASSETS](index=22&type=section&id=5.%20INTANGIBLE%20ASSETS) Net intangible assets decreased to $723,855 due to amortization, with future amortization expenses scheduled over several years Intangible Assets, Net | Asset Category | July 31, 2023 | January 31, 2023 | | :----------------------------- | :------------ | :--------------- | | Customer base | $314,100 | $314,100 | | Intellectual property and trademarks | $817,400 | $817,400 | | Total | $1,131,500 | $1,131,500 | | Less: Accumulated amortization | $(407,645) | $(351,070) | | Net Intangible Assets | $723,855 | $780,430 | - Amortization expenses for the six months ended July 31, 2023, were **$56,575**[80](index=80&type=chunk) Future Amortization Schedule | Year Ended January 31, | Amortization | | :--------------------- | :----------- | | 2024 | $56,534 | | 2025 | $113,109 | | 2026 | $113,109 | | 2027 | $113,109 | | 2028 | $113,109 | | 2029 and thereafter | $214,885 | | Total | $723,855 | [6. RELATED PARTY TRANSACTIONS](index=24&type=section&id=6.%20RELATED%20PARTY%20TRANSACTIONS) The company maintains a significant credit line facility with TII Jet Services LDA, a shareholder - The company entered into an amended **$5,000,000 Credit Line Note facility** with TII Jet Services LDA, a shareholder of the Company, on July 17, 2023[77](index=77&type=chunk)[90](index=90&type=chunk) [7. STOCKHOLDERS' EQUITY](index=24&type=section&id=7.%20STOCKHOLDERS'%20EQUITY) Stockholders' equity changes reflect a forward stock split, issuance of options and warrants, and a common stock cancellation - The company's authorized common stock increased to **291,666,666 shares** following a 7-for-6 forward stock split effective August 12, 2022[87](index=87&type=chunk) - Options to purchase **30,000 shares** were issued to an executive, valued at **$75,030**, and expensed during the six months ended July 31, 2023[90](index=90&type=chunk) - In July 2022, the company cancelled **1,400,000 shares** of common stock following a favorable lawsuit settlement[91](index=91&type=chunk) [8. OPTIONS and WARRANTS](index=26&type=section&id=8.%20OPTIONS%20and%20WARRANTS) This section summarizes changes in outstanding warrants and stock options, including new grants, expirations, and valuation details Warrant Activity | Warrants | January 31, 2022 | January 31, 2023 | July 31, 2023 | | :---------------------- | :--------------- | :--------------- | :------------ | | Outstanding Shares | 1,435,622 | 1,307,671 | 1,283,038 | | Weighted Average Price | $6.91 | $6.43 | $6.14 | | Remaining Life (Years) | 3.93 | 3.34 | 3.02 | | Granted (6 months ended July 31, 2023) | - | - | 30,000 | | Expired/Cancelled (6 months ended July 31, 2023) | - | - | (54,633) | Option Activity | Options | January 31, 2022 | January 31, 2023 | July 31, 2023 | | :---------------------- | :--------------- | :--------------- | :------------ | | Outstanding Shares | 190,751 | 470,335 | 500,335 | | Weighted Average Price | $4.26 | $4.13 | $4.12 | | Remaining Life (Years) | 2.97 | 2.53 | 2.06 | | Granted (6 months ended July 31, 2023) | - | - | 30,000 | | Intrinsic Value (July 31, 2023) | - | - | $19,475 | - The fair value of options issued for services during the six months ended July 31, 2023, amounted to **$75,030**, valued using the Black-Scholes model[97](index=97&type=chunk) [9. SEGMENT REPORTING](index=29&type=section&id=9.%20SEGMENT%20REPORTING) The company operates in two segments, Sales of Goods and Services, with all revenue generated within the United States Segment Performance | Segment | 6 Months Ended July 31, 2023 Net Sales | 6 Months Ended July 31, 2022 Net Sales | 6 Months Ended July 31, 2023 Gross Profit | 6 Months Ended July 31, 2022 Gross Profit | | :--------------------- | :------------------------------------- | :------------------------------------- | :--------------------------------------- | :--------------------------------------- | | Pocono Pharmaceuticals | $967,826 | $796,894 | $400,061 | $364,112 | | 4P Therapeutics | $165,034 | $137,177 | $121,895 | $(11,830) | | Total | $1,132,860 | $934,071 | $521,956 | $352,282 | - All net sales and property and equipment are located within the **United States**[102](index=102&type=chunk) [10. COMMITMENTS AND CONTINGENCIES](index=30&type=section&id=10.%20COMMITMENTS%20AND%20CONTIGENCIES) The company has employment agreements with executives and a significant development agreement for its AVERSAL Fentanyl product - CEO and President annual salaries were mutually reduced from **$250,000 to $150,000**, and CFO's salary from **$210,000 to $110,000**, effective July 31, 2022[103](index=103&type=chunk)[104](index=104&type=chunk) - A feasibility agreement with Kindeva Drug Delivery for AVERSAL Fentanyl development has an estimated cost of **$2.3 million**, with **$1,510,000** incurred as of July 31, 2023[105](index=105&type=chunk)[107](index=107&type=chunk) - The company terminated its Securities Facility Services Agreement for dual listing on the **MERJ Upstream exchange**, effective May 31, 2023[112](index=112&type=chunk) [11. SUBSEQUENT EVENTS](index=31&type=section&id=11.%20SUBSEQUENT%20EVENTS) The company is involved in a dispute over offering cancellation fees, with an uncertain outcome and no estimable loss - The company is in a dispute with Joseph A. Gunnar over fees related to an offering cancellation, with the outcome currently **uncertain** and no reasonable estimate of loss[114](index=114&type=chunk) - Management believes current legal actions will not materially adversely affect the company's business or financial position[115](index=115&type=chunk) [ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS](index=32&type=section&id=Item%202%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's financial performance, liquidity, and capital resources, focusing on its transdermal pharmaceutical business [Overview](index=32&type=section&id=Overview) The company's primary focus is developing its AVERSA™ abuse-deterrent fentanyl system, which requires significant capital and FDA approval - The primary business is the development of transdermal pharmaceutical products, with the lead product being the **AVERSA™ abuse-deterrent fentanyl transdermal system**[123](index=123&type=chunk) - The company's focus expanded to prescription pharmaceuticals after the **4P Therapeutics acquisition** in 2018 and now provides contract manufacturing services[124](index=124&type=chunk)[125](index=125&type=chunk) - Approximately **$13 million** is required for research and development of the abuse-deterrent fentanyl transdermal system[128](index=128&type=chunk) - The company consummated a public offering in October 2021, receiving net proceeds of **$5,836,230**, and has received **$2,942,970** from warrant exercises as of July 31, 2023[130](index=130&type=chunk) - A three-year **$5,000,000 credit line facility** was entered into on July 13, 2023, to fund the FDA approval process and commercial manufacturing of AVERSA™ Fentanyl[135](index=135&type=chunk)[136](index=136&type=chunk) [Results of Operations](index=36&type=section&id=Results%20of%20Operations) Revenue grew in recent periods, but higher R&D expenses for the Aversa Fentanyl product led to increased net losses [Three Months Ended July 31, 2023 and 2022](index=36&type=section&id=Three%20Months%20Ended%20July%2031%2C%202023%20and%202022) Revenue increased to $655,928, and despite lower SG&A costs, a rise in R&D expenses resulted in a net loss of $829,173 Three-Month Operational Performance | Metric | 3 Months Ended July 31, 2023 | 3 Months Ended July 31, 2022 | Change (YoY) | | :----------------------------------- | :--------------------------- | :--------------------------- | :----------- | | Revenue | $655,928 | $456,149 | +43.8% | | Gross Margin | $299,672 | $151,796 | +97.4% | | Selling, General and Administrative | $678,738 | $908,173 | -25.3% | | Research and Development | $445,122 | $277,869 | +60.2% | | Net Loss | $(829,173) | $(1,038,675) | -20.2% | | Net Loss Per Share (Basic & Diluted) | $(0.11) | $(0.12) | -8.3% | [Six Months Ended July 31, 2023 and 2022](index=36&type=section&id=Six%20Months%20Ended%20July%2031%2C%202023%20and%202022) Revenue increased to $1,132,860, but R&D expenses more than doubled, leading to a higher net loss of $1,844,402 Six-Month Operational Performance | Metric | 6 Months Ended July 31, 2023 | 6 Months Ended July 31, 2022 | Change (YoY) | | :----------------------------------- | :--------------------------- | :--------------------------- | :----------- | | Revenue | $1,132,860 | $934,071 | +21.3% | | Gross Margin | $521,956 | $352,282 | +48.2% | | Selling, General and Administrative | $1,518,470 | $1,676,624 | -9.4% | | Research and Development | $845,552 | $395,683 | +113.7% | | Net Loss | $(1,844,402) | $(1,728,664) | +6.7% | | Net Loss Per Share (Basic & Diluted) | $(0.24) | $(0.20) | +20.0% | [Liquidity and Capital Resources](index=36&type=section&id=Liquidity%20and%20Capital%20Resources) The company's cash position and working capital improved due to a $2 million credit line drawdown and a factoring arrangement Key Liquidity Metrics | Metric | July 31, 2023 | January 31, 2023 | | :----------------------- | :------------ | :--------------- | | Cash and cash equivalents | $2,334,553 | $1,985,440 | | Working capital | $2,399,446 | $1,945,132 | - The company used **$1,744,999 in cash from operations** and **$2,624 in investing activities** for the six months ended July 31, 2023[146](index=146&type=chunk)[148](index=148&type=chunk) - Cash provided by financing activities totaled **$2,096,736**, mainly from a **$2,000,000 credit line drawdown** and **$106,528** from a factoring arrangement[148](index=148&type=chunk) [Off Balance Sheet Arrangements](index=38&type=section&id=Off%20Balance%20Sheet%20Arrangements) The company has no off-balance sheet arrangements that are likely to materially affect its financial condition or liquidity - The company has **no off-balance sheet arrangements**[149](index=149&type=chunk) [Critical Accounting Policies](index=38&type=section&id=Critical%20Accounting%20Policies) Critical accounting policies include the going concern assessment, use of estimates, revenue recognition, and asset valuation methods - Management believes the company can continue as a **going concern** for at least one year, supported by current cash and a **$5 million credit line**[151](index=151&type=chunk)[152](index=152&type=chunk)[153](index=153&type=chunk) - The company's accounting policies are consistent with those detailed in **Note 2** of the financial statements[154](index=154&type=chunk)[155](index=155&type=chunk)[156](index=156&type=chunk)[158](index=158&type=chunk)[159](index=159&type=chunk)[160](index=160&type=chunk)[161](index=161&type=chunk)[162](index=162&type=chunk)[163](index=163&type=chunk)[164](index=164&type=chunk)[166](index=166&type=chunk)[167](index=167&type=chunk)[168](index=168&type=chunk) [ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK](index=42&type=section&id=Item%203%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) There are no quantitative and qualitative disclosures about market risk applicable to the company - Quantitative and qualitative disclosures about market risk are **not applicable** to the company[169](index=169&type=chunk) [ITEM 4. CONTROLS AND PROCEDURES](index=42&type=section&id=Item%204%20Controls%20and%20Procedures) Disclosure controls were deemed ineffective due to material weaknesses, and management has initiated remediation efforts - Disclosure controls and procedures were evaluated as **not effective** as of July 31, 2023[171](index=171&type=chunk) - Material weaknesses identified include **absence of segregation of duties** and a **lack of qualified accounting personnel**[172](index=172&type=chunk) - Improvements include adding qualified accounting personnel and establishing additional monitoring controls[172](index=172&type=chunk) - **No material changes** were made to internal controls over financial reporting during the quarter[174](index=174&type=chunk) [PART II. OTHER INFORMATION](index=43&type=section&id=Part%20II%3A%20Other%20Information) [ITEM 1. LEGAL PROCEEDINGS](index=43&type=section&id=Item%201%20Legal%20Proceedings) This section states that there are no legal proceedings to report - There are **no legal proceedings** to report[177](index=177&type=chunk) [ITEM 1A. RISK FACTORS](index=43&type=section&id=Item%201A%20Risk%20Factors) The company faces significant risks related to its early-stage status, history of losses, and uncertainty of FDA approval - The company is an **early-stage enterprise** with minimal revenue and a history of losses, expecting to incur further losses[179](index=179&type=chunk) - There is **no assurance of obtaining FDA approval** for its lead product, which is critical for future profitability[180](index=180&type=chunk)[181](index=181&type=chunk) - The business is susceptible to adverse effects from **health pandemics**, such as COVID-19, which could disrupt operations and delay clinical programs[181](index=181&type=chunk) - Other key risks include challenges in establishing distribution networks and FDA-compliant manufacturing facilities[181](index=181&type=chunk)[182](index=182&type=chunk) [ITEM 6. EXHIBITS](index=45&type=section&id=Item%206%20Exhibits) This section lists all exhibits filed with the Form 10-Q, including certifications and XBRL documents - The exhibits include **Section 302 and 906 certifications** from the CEO and CFO, as well as various Inline XBRL documents[183](index=183&type=chunk) [SIGNATURES](index=46&type=section&id=SIGNATURES) This section contains the required signatures of the company's executive officers certifying the report - The report is signed by **Gareth Sheridan, Chief Executive Officer**, and **Gerald Goodman, Chief Financial Officer**, on September 8, 2023[187](index=187&type=chunk)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended April 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________ to __________ Commission File Number 000-55654 NUTRIBAND INC. (Exact name of registrant as specified in its charter) | NEVADA | 81-1118176 | | --- | --- | | (State ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended January 31, 2023 or ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________ to __________ Commission file number 000-55654 NUTRIBAND INC. (Exact name of registrant as specified in its charter) | Nevada | 81-1118176 | | --- | --- | | (State or oth ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended October 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________ to __________ Commission File Number 000-55654 NUTRIBAND INC. (Exact name of registrant as specified in its charter) | NEVADA | 81-1118176 | | --- | --- | | (Stat ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended July 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________ to __________ Commission File Number 000-55654 NUTRIBAND INC. (Exact name of registrant as specified in its charter) | NEVADA | 81-1118176 | | --- | --- | | (State o ...

Part I [Financial Statements](index=3&type=section&id=Item%201%20Financial%20Statements) For the three months ended April 30, 2022, the company reported increased revenue but a significantly widened net loss due to higher operating costs, leading to decreased cash and negative operating cash flow Condensed Consolidated Balance Sheet Highlights (Unaudited) | Account | April 30, 2022 | January 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $4,010,644 | $4,891,868 | | Total Current Assets | $4,641,912 | $5,465,368 | | Goodwill | $5,349,039 | $5,349,039 | | **Total Assets** | **$11,984,475** | **$12,739,660** | | **Liabilities & Equity** | | | | Total Current Liabilities | $723,057 | $779,256 | | Total Liabilities | $904,375 | $880,375 | | Total Stockholders' Equity | $11,080,100 | $11,859,285 | | **Total Liabilities and Stockholders' Equity** | **$11,984,475** | **$12,739,660** | Condensed Consolidated Statements of Operations Highlights (Unaudited) | Account | Three Months Ended April 30, 2022 | Three Months Ended April 30, 2021 | | :--- | :--- | :--- | | Revenue | $477,922 | $433,488 | | Cost of revenues | $277,436 | $195,610 | | Research and development expenses | $117,814 | $ - | | Selling, general and administrative expenses | $768,551 | $551,942 | | Loss from operations | $(685,879) | $(314,064) | | **Net loss** | **$(689,989)** | **$(315,057)** | | **Net loss per share - basic and diluted** | **$(0.09)** | **$(0.05)** | Condensed Consolidated Statements of Cash Flows Highlights (Unaudited) | Cash Flow Activity | Three Months Ended April 30, 2022 | Three Months Ended April 30, 2021 | | :--- | :--- | :--- | | Net Cash Used In Operating Activities | $(744,257) | $(279,415) | | Net Cash Used in Investing Activities | $(43,803) | $(38,779) | | Net Cash Provided by (used in) Financing Activities | $(93,164) | $576,955 | | **Net change in cash** | **$(881,224)** | **$258,761** | | **Cash and cash equivalents - End of period** | **$4,010,644** | **$410,754** | [Notes to Unaudited Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the company's strategic shift to transdermal pharmaceutical product development, its going concern assessment, key product development agreements, revenue disaggregation, and ongoing legal proceedings - The company's principal business is now the development of **transdermal pharmaceutical products**, a shift that occurred after the acquisition of 4P Therapeutics in 2018[22](index=22&type=chunk) - Management believes that the net proceeds of **$5,836,230** from a public offering in October 2021 and **$2,942,970** from warrant exercises alleviate substantial doubt about the company's ability to continue as a going concern, despite historical operating losses[30](index=30&type=chunk)[32](index=32&type=chunk) Revenue Disaggregation by Type (Three Months Ended April 30) | Revenue Type | 2022 | 2021 | | :--- | :--- | :--- | | Sale of goods | $401,990 | $327,512 | | Services | $75,932 | $105,976 | | **Total** | **$477,922** | **$433,488** | - The company signed a feasibility agreement with Kindeva Drug Delivery in January 2022 to develop its lead product, AVERSAL Fentanyl, with an estimated cost of **$1.7 million** over 8-12 months[96](index=96&type=chunk)[98](index=98&type=chunk) - The development of the RAMBAM CSTD Device has been **suspended** as preliminary reviews found the product was not commercially viable in its current form[93](index=93&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=24&type=section&id=Item%202%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the strategic shift to transdermal pharmaceutical product development, acknowledging the early stage, history of losses, and significant capital requirements, while affirming sufficient liquidity for the next year despite increased net loss - The company's primary business is the development of **transdermal pharmaceutical products**, with its lead product being an **abuse-deterrent fentanyl transdermal system (AVERSA™)**[108](index=108&type=chunk) - The company has budgeted **$5.0 million** for research and development of its abuse-deterrent fentanyl transdermal system, but acknowledges the total cost could be substantially higher[113](index=113&type=chunk) Results of Operations Comparison (Three Months Ended April 30) | Metric | 2022 | 2021 | | :--- | :--- | :--- | | Revenue | $477,922 | $433,488 | | Gross Margin | $200,486 | $237,878 | | SG&A Expenses | $768,551 | $551,942 | | R&D Expenses | $117,814 | $ - | | Net Loss | $(689,989) | $(315,957) | - As of April 30, 2022, the company had **$4,010,644** in cash and cash equivalents and working capital of **$3,918,855**, which management believes are sufficient for operations for at least one year[127](index=127&type=chunk)[133](index=133&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=30&type=section&id=Item%203%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company has determined that quantitative and qualitative disclosures about market risk are not applicable for this reporting period - The company has determined that quantitative and qualitative disclosures about market risk are **not applicable** for this reporting period[146](index=146&type=chunk) [Controls and Procedures](index=30&type=section&id=Item%204%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were not effective due to identified material weaknesses, including lack of segregation of duties, with remediation efforts underway - The company's disclosure controls and procedures were concluded to be **not effective** as of the end of the period covered by the report[148](index=148&type=chunk) - **Material weaknesses** were identified due to the **absence of segregation of duties** and **excessive reliance on third-party consultants** for accounting and financial reporting[149](index=149&type=chunk) - **Remediation efforts** include adding qualified accounting personnel and improving internal controls over revenue, accounts receivable, and accounts payable transactions[149](index=149&type=chunk) Part II [Risk Factors](index=31&type=section&id=Item%201A%20Risk%20Factors) The company identifies significant risks related to its early-stage operations, including funding, clinical trial success, FDA approval, health pandemics, competition, product liability, and intellectual property protection - The company is an **early-stage enterprise** with a **history of losses** and expects to continue incurring losses, making **future profitability uncertain**[156](index=156&type=chunk) - Major risks include the ability to obtain **necessary funding**, **success of clinical trials**, obtaining **FDA approval**, and **market acceptance** of products[160](index=160&type=chunk) - The business could be adversely affected by **health pandemics like COVID-19**, which may disrupt business operations, delay clinical programs, and impact the supply chain[160](index=160&type=chunk) - The company may not be able to **protect its intellectual property rights** and could be subject to **expensive and disruptive litigation**[164](index=164&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=34&type=section&id=Item%202%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) While no unregistered sales occurred during the quarter, the company subsequently issued 24,500 shares as compensation and purchased 23,002 shares for treasury stock in March 2022 - On May 10, 2022, the company issued **24,500 shares** of common stock to directors, management, employees, and consultants as compensation[161](index=161&type=chunk)[101](index=101&type=chunk) - In March 2022, the company purchased **23,002 shares** of its common stock for **$89,186**, which were recorded as Treasury Stock[162](index=162&type=chunk) [Exhibits](index=36&type=section&id=Item%206%20Exhibits) This section lists the exhibits filed with the quarterly report, including CEO and CFO certifications and Inline XBRL data files - Exhibits filed include **CEO and CFO certifications** pursuant to **Sarbanes-Oxley Sections 302 and 906**[166](index=166&type=chunk) - The filing includes **Inline XBRL documents** for financial data tagging (Instance, Schema, Calculation, Definition, Label, Presentation)[166](index=166&type=chunk)

[FORM 10-K Cover Page](index=1&type=section&id=FORM%2010-K%20Cover%20Page) Nutriband Inc. is a non-accelerated filer, smaller reporting, and emerging growth company, opting out of extended accounting transition periods - Nutriband Inc. is a non-accelerated filer, smaller reporting company, and emerging growth company, opting out of the extended transition period for new accounting standards[4](index=4&type=chunk)[5](index=5&type=chunk) Key Filing Status and Market Data (as of Jan 31, 2022) | Metric | Value | | :--- | :--- | | Fiscal Year Ended | January 31, 2022 | | Filer Status | Non-accelerated, Smaller Reporting, Emerging Growth | | Market Value of Non-Affiliate Common Equity (July 31, 2021) | $33,326,538 | | Common Stock Outstanding (April 22, 2022) | 7,821,176 shares | [Forward-Looking Statements](index=4&type=section&id=FORWARD%20LOOKING%20STATEMENTS) Forward-looking statements are subject to various risks and uncertainties, and the company does not commit to updating them - Forward-looking statements are subject to risks and uncertainties, including financing, FDA approval, COVID-19 impact, intellectual property, and competition, and actual results may vary materially[13](index=13&type=chunk)[14](index=14&type=chunk)[16](index=16&type=chunk)[17](index=17&type=chunk) - The company does not assume any obligation to update any forward-looking statement[15](index=15&type=chunk)[16](index=16&type=chunk) [PART I](index=6&type=section&id=PART%20I) [Business Overview](index=6&type=section&id=Item%201.%20Business) Nutriband Inc. develops transdermal pharmaceutical products, with AVERSA™ abuse-deterrent fentanyl patch as its lead, and provides contract manufacturing - Primary business is the development of transdermal pharmaceutical products, with AVERSA™ technology for abuse deterrence as the lead product[21](index=21&type=chunk)[23](index=23&type=chunk) - Acquired 4P Therapeutics in August 2018 to shift focus to pharmaceutical transdermal products and Pocono Coated Products in August 2020 for contract manufacturing services[21](index=21&type=chunk)[29](index=29&type=chunk)[30](index=30&type=chunk)[33](index=33&type=chunk) [Business Summary](index=6&type=section&id=SUMMARY) Nutriband Inc. focuses on developing transdermal pharmaceutical products, with AVERSA™ abuse-deterrent technology as its core, and offers contract manufacturing - Nutriband Inc.'s core business is the development of transdermal pharmaceutical products, with AVERSA™ technology for abuse deterrence as the lead product, specifically an AVERSA fentanyl patch[21](index=21&type=chunk) - The company also manufactures transdermal, topical, coated, and consumer products on a contract basis following the acquisition of Pocono Coated Products[21](index=21&type=chunk) [Selected Business Risks](index=6&type=section&id=Selected%20Risks%20Associated%20with%20our%20Business%20and%20Operations) The business faces significant risks from health pandemics, lengthy FDA approval processes, product launch challenges, and intellectual property protection issues - Significant risks include adverse effects from health pandemics (e.g., COVID-19), lengthy and expensive FDA regulatory processes with no guarantee of approval, and challenges in product launch, distribution, and manufacturing[22](index=22&type=chunk)[25](index=25&type=chunk) - Other risks involve the inability to secure joint ventures or strategic relationships, protect intellectual property, manage unanticipated side effects, comply with regulations, and estimate financial needs accurately[25](index=25&type=chunk) [Our Business and Product Pipeline](index=7&type=section&id=Our%20Business) The company develops transdermal pharmaceutical products using AVERSA abuse-deterrent technology, with AVERSA Fentanyl as its lead, and explores other transdermal delivery systems - The company's core business is developing transdermal pharmaceutical products using proprietary AVERSA abuse-deterrent technology, applicable to drugs susceptible to abuse[23](index=23&type=chunk)[24](index=24&type=chunk) - Lead product is AVERSA Fentanyl, an abuse-deterrent fentanyl transdermal system, with plans to expand to AVERSA Buprenorphine and AVERSA Methylphenidate[24](index=24&type=chunk) - Also developing transdermal delivery systems for approved injectable drugs like exenatide (type 2 diabetes) and FSH (infertility) to improve compliance and outcomes[24](index=24&type=chunk)[31](index=31&type=chunk) - A feasibility agreement with Kindeva Drug Delivery is in place for AVERSA Fentanyl development, focusing on integrating AVERSA technology into Kindeva's FDA-approved fentanyl patch manufacturing process[26](index=26&type=chunk) - The regulatory path for AVERSA products is planned as a 505(b)(2) NDA submission, leveraging existing safety and efficacy data for the reference-listed drug[27](index=27&type=chunk) [Acquisition of 4P Therapeutics](index=8&type=section&id=Acquisition%20of%204P%20Therapeutics) The 2018 acquisition of 4P Therapeutics shifted the company's focus to pharmaceutical transdermal products, including AVERSA Fentanyl, and added contract R&D - Acquired 4P Therapeutics on August 1, 2018, for **$2,250,000** (62,500 common shares valued at **$1,850,000** and **$400,000** cash), plus a **6% royalty** on revenue from acquired abuse-deterrent intellectual property[29](index=29&type=chunk) - The acquisition shifted the company's business focus from consumer transdermal products to 4P Therapeutics' portfolio of pharmaceutical transdermal products, including AVERSA Fentanyl[30](index=30&type=chunk)[31](index=31&type=chunk) - 4P Therapeutics also performs contract research and development services for life sciences clients to support operations, though significant revenues are not expected from these services[32](index=32&type=chunk) [Acquisition of Pocono Coated Products](index=9&type=section&id=Acquisition%20of%20Pocono%20Coated%20Products) The 2020 acquisition of Pocono Coated Products expanded the company's capabilities into contract manufacturing of transdermal, topical, and consumer products - Formed Pocono Pharmaceuticals Inc. on August 25, 2020, and acquired the Transdermal, Topical, Cosmetic, and Nutraceutical business assets and liabilities of Pocono Coated Products (PCP) on August 31, 2020[33](index=33&type=chunk) - The purchase price included **$6,000,000** in 608,519 common shares and a **$1,500,000** promissory note (paid in full by October 1, 2021), also including Active Intelligence LLC[33](index=33&type=chunk) [Company Organization and Status](index=9&type=section&id=Our%20Organization) Incorporated in Nevada in 2016, Nutriband Inc. qualifies as an 'emerging growth company' and 'smaller reporting company,' benefiting from reduced reporting - Nutriband Inc. was incorporated in Nevada on January 4, 2016, acquiring Nutriband Ltd., an Irish company founded in 2012[34](index=34&type=chunk) - Qualifies as an 'emerging growth company' under the JOBS Act, allowing for reduced reporting requirements, such as presenting two years of audited financial statements and exemptions from certain executive compensation disclosures[35](index=35&type=chunk)[36](index=36&type=chunk)[37](index=37&type=chunk) - The company will continue to qualify as a 'smaller reporting company' as long as its public float is less than **$250 million** or annual revenues are less than **$100 million** with a public float under **$700 million**[38](index=38&type=chunk) [COVID-19 Pandemic Effects](index=10&type=section&id=Effects%20of%20the%20COVID-19%20Pandemic) The COVID-19 pandemic may negatively impact the company's financing, joint ventures, supply chain, and regulatory approvals - The COVID-19 pandemic may adversely affect the company's ability to raise financing, enter joint ventures, and perform contract services due to market uncertainty and investor focus on COVID-19 related products[39](index=39&type=chunk)[40](index=40&type=chunk) - Potential impacts include reduced investor willingness, financial health of customers, supply chain disruptions, and delays in regulatory approval for consumer patches[40](index=40&type=chunk) [Detailed Pharmaceutical Products in Development](index=11&type=section&id=Pharmaceutical%20Products%20in%20Development) The company develops AVERSA Fentanyl and other abuse-deterrent transdermal products, plus transdermal delivery systems for existing injectable drugs, contingent on funding - AVERSA Fentanyl is designed to deter abuse of fentanyl patches by oral, buccal, and inhaled routes, incorporating taste and sensory aversive agents on the patch backing, separate from the drug matrix[41](index=41&type=chunk) - The AVERSA technology has broad applicability to other transdermal products, with plans to develop AVERSA Buprenorphine and AVERSA Methylphenidate[42](index=42&type=chunk) - Research pipeline includes off-patent drug compounds for transdermal delivery (e.g., exenatide for type 2 diabetes, FSH for infertility) as alternatives to injections, aiming for improved compliance and safety[43](index=43&type=chunk)[44](index=44&type=chunk)[45](index=45&type=chunk)[47](index=47&type=chunk) - The company plans to utilize the 505(b)(2) NDA regulatory pathway for these products, referencing existing safety data to reduce clinical trial requirements, though FDA concurrence is not assured[43](index=43&type=chunk)[45](index=45&type=chunk)[47](index=47&type=chunk) - Development of these products is contingent on securing sufficient funding or joint venture agreements[49](index=49&type=chunk) [Pharmaceutical Manufacturing and Supply](index=12&type=section&id=Pharmaceutical%20Manufacturing%20and%20Supply) Manufacturing of pharmaceutical transdermal products will be outsourced to FDA cGMP-compliant contract manufacturers, subject to regulatory review and inspection - Manufacturing of pharmaceutical transdermal products will be outsourced to contract manufacturers compliant with FDA cGMP and local regulations[51](index=51&type=chunk) - All manufacturing processes and facilities are subject to FDA review and inspection during development, prior to approval, and routinely thereafter[51](index=51&type=chunk) [Employees](index=12&type=section&id=Employees) As of January 31, 2022, the company had 13 full-time employees, including five officers, with no union representation - As of January 31, 2022, the company had **13 full-time employees**, including five officers, with no union representation[52](index=52&type=chunk) [Government Regulation](index=12&type=section&id=Government%20Regulation) The pharmaceutical business is extensively regulated by the FDA and international authorities, requiring lengthy approval, post-approval compliance, and cGMP adherence - The pharmaceutical business is subject to extensive government regulation, primarily by the FDA in the United States and by respective authorities in other countries[53](index=53&type=chunk) - FDA approval for drug-device combinations, even with approved drugs, requires preclinical and clinical trials, with the AVERSA products aiming for the 505(b)(2) NDA pathway to leverage existing safety data[55](index=55&type=chunk) - The full FDA regulatory pathway involves preclinical, Phase 1, Phase 2, and Phase 3 clinical trials, followed by a New Drug Application (NDA) submission and review[56](index=56&type=chunk)[57](index=57&type=chunk) - Post-approval requirements include ongoing FDA regulation, record-keeping, adverse event reporting, compliance with cGMP, and restrictions on promotion and advertising[65](index=65&type=chunk)[67](index=67&type=chunk) - International market access requires compliance with varying regulatory requirements in each country, which can be time-consuming and may involve additional testing and pricing negotiations[72](index=72&type=chunk)[75](index=75&type=chunk)[76](index=76&type=chunk)[77](index=77&type=chunk) [Intellectual Property](index=17&type=section&id=Intellectual%20Property) AVERSA abuse-deterrent technology is protected by an international patent portfolio covering 44 countries until 2035, supplemented by trade secrets and trademarks - The AVERSA abuse-deterrent technology is protected by an international intellectual property portfolio with patents issued in **44 countries** (including US, Europe, Japan, Korea, Russia, Mexico, Australia) and pending in Canada and China, providing coverage until **2035**[80](index=80&type=chunk) - The company also relies on trade secrets and seeks trademark protection for names like Nutriband and AVERSA[80](index=80&type=chunk)[81](index=81&type=chunk) [Competition](index=17&type=section&id=Competition) The pharmaceutical industry is highly competitive, with AVERSA opioid products aiming to deter abuse and misuse against existing and developing technologies - The pharmaceutical industry is highly competitive, with potential competitors including large pharmaceutical, biotechnology, specialty, and generic drug companies[82](index=82&type=chunk) - Key competitive factors include product performance (safety, efficacy), patient compliance, healthcare professional acceptance, and insurance reimbursement[82](index=82&type=chunk) - AVERSA opioid products aim to deter abuse and misuse, competing with existing non-abuse-deterrent products and other abuse-deterrent technologies, though no other abuse-deterrent transdermal products are currently known to be in development or marketed[83](index=83&type=chunk) [Risk Factors](index=18&type=section&id=Item%201A.%20Risk%20Factors) This section details significant risks that could adversely affect Nutriband Inc.'s business, financial condition, and stock price, including operational, regulatory, and market challenges - Investment in common stock is highly speculative due to the company's early stage, minimal revenue, history of losses, and expected future substantial losses[85](index=85&type=chunk)[86](index=86&type=chunk) - External factors like the Russia/Belarus-Ukrainian conflict and the COVID-19 pandemic pose risks to financing, supply chains, and overall economic stability, potentially impacting business operations[87](index=87&type=chunk)[88](index=88&type=chunk) [Business-Specific Risks](index=18&type=section&id=Risks%20Concerning%20our%20Business) The company faces risks from a history of losses, reliance on FDA approval, manufacturing dependencies, product liability, and intense market competition - The company has a history of losses (**$6,372,715** in FY2022) and negative cash flow from operations (**$2,809,223** in FY2022), with no assurance of future profitability[86](index=86&type=chunk) - Failure to develop and obtain FDA approval for the lead product, AVERSA fentanyl transdermal system, could jeopardize the company's ability to continue in business[89](index=89&type=chunk)[90](index=90&type=chunk) - Significant delays in clinical trials, reliance on third-party contract research organizations, and the extensive FDA approval process (including potential REMS policies and post-approval review) pose substantial risks to market entry and commercial success[92](index=92&type=chunk)[93](index=93&type=chunk)[94](index=94&type=chunk)[97](index=97&type=chunk)[104](index=104&type=chunk)[106](index=106&type=chunk)[107](index=107&type=chunk) - Lack of commercial manufacturing capability necessitates reliance on FDA-approved contract manufacturers, introducing risks related to quality, regulatory compliance, and favorable pricing[101](index=101&type=chunk)[102](index=102&type=chunk) - Product liability claims, especially for products with severe side effects like fentanyl, could exceed insurance coverage and harm the company's reputation and financial stability[119](index=119&type=chunk)[120](index=120&type=chunk) - The company may need to enter joint ventures or strategic alliances for product development and marketing, potentially requiring giving up significant equity or rights[122](index=122&type=chunk) - Failure to achieve broad physician or market acceptance, keep up with rapid technological changes, or compete effectively against better-capitalized companies could adversely affect operating results[124](index=124&type=chunk)[127](index=127&type=chunk)[128](index=128&type=chunk) - Healthcare reforms and reductions in pharmaceutical pricing/reimbursement by third-party payors could decrease product utilization and revenue[129](index=129&type=chunk)[130](index=130&type=chunk)[131](index=131&type=chunk)[133](index=133&type=chunk)[134](index=134&type=chunk) - Protecting intellectual property is difficult and costly, with risks of patent challenges, infringement by third parties, and inability to fund litigation[135](index=135&type=chunk)[136](index=136&type=chunk)[137](index=137&type=chunk)[139](index=139&type=chunk)[140](index=140&type=chunk) - Past and future acquisitions carry risks of integration difficulties, key employee resignations, undisclosed liabilities, and failure to meet anticipated value or profitability[139](index=139&type=chunk)[141](index=141&type=chunk)[142](index=142&type=chunk) [Securities-Related Risks](index=32&type=section&id=Risks%20Concerning%20our%20Securities) Risks include ineffective internal controls, stock price volatility, potential dilution from future equity issuances, Nasdaq de-listing, and significant insider ownership - Ineffective internal controls over financial reporting, due to limited staff and recent acquisitions, may deter investors and complicate capital raising[148](index=148&type=chunk)[351](index=351&type=chunk)[352](index=352&type=chunk) - Low trading volume in common stock may lead to price volatility and susceptibility to manipulation, influenced by financial condition, funding ability, regulatory changes, and litigation[149](index=149&type=chunk)[150](index=150&type=chunk)[156](index=156&type=chunk)[158](index=158&type=chunk) - Future equity or convertible debt issuances to raise substantial funds will likely result in significant dilution for existing stockholders[151](index=151&type=chunk)[152](index=152&type=chunk)[159](index=159&type=chunk)[160](index=160&type=chunk) - Failure to meet Nasdaq continued listing requirements could result in de-listing, negatively impacting stock price and liquidity[153](index=153&type=chunk) - A settled SEC investigation regarding inaccurate disclosures may affect market perception and stock exchange listing ability[154](index=154&type=chunk) - Executive officers and directors collectively own approximately **32%** of common stock, giving them significant power over director elections and stockholder approvals[157](index=157&type=chunk) - The company does not intend to pay cash dividends in the foreseeable future[163](index=163&type=chunk) [Unresolved Staff Comments](index=36&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) This item states that there are no unresolved staff comments applicable to the company - No unresolved staff comments are applicable[164](index=164&type=chunk) [Properties](index=36&type=section&id=Item%202.%20Properties) Nutriband Inc. leases an office in Orlando, Florida, and manufacturing space in Cherryville, North Carolina, under a three-year lease with a renewal option - The company leases an office in Orlando, Florida, for **$2,500/month** and manufacturing space in Cherryville, North Carolina, for **$3,000/month**[165](index=165&type=chunk) - The manufacturing lease, effective February 1, 2022, is for three years with a renewal option[165](index=165&type=chunk) [Legal Proceedings](index=36&type=section&id=Item%203.%20Legal%20Proceedings) Nutriband Inc. settled an SEC administrative proceeding and is engaged in ongoing litigation to rescind an acquisition and recover common shares - Settled an SEC administrative cease-and-desist proceeding on December 26, 2018, for violations related to inaccurate registration statements and annual reports; officers paid **$25,000** civil penalties each[166](index=166&type=chunk)[167](index=167&type=chunk) - Ongoing litigation in Florida and New York against Advanced Health Brands, Inc. and its stockholders to rescind a 2017 acquisition and recover **1,250,000** common shares due to alleged misrepresentation and fraudulent conduct[168](index=168&type=chunk)[170](index=170&type=chunk) - A Florida district court of appeal reversed a lower court's dismissal, allowing the company to file an amended complaint in the Florida action[168](index=168&type=chunk) - The U.S. District Court for the Eastern District of New York denied the defendants' motion to dismiss the securities fraud action, with a trial scheduled for June 2022[170](index=170&type=chunk) [Mine Safety Disclosures](index=36&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item states that mine safety disclosures are not applicable to the company - Mine safety disclosures are not applicable to the company[171](index=171&type=chunk) [PART II](index=38&type=section&id=PART%20II) [Market for Common Equity, Stockholder Matters, and Equity Purchases](index=38&type=section&id=Item%205.%20Market%20for%20Registrant's%20Common%20Equity,%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) Nutriband Inc.'s common stock and warrants trade on NASDAQ, with approximately 83 record holders, no anticipated cash dividends, and a recent share repurchase - Common stock (NTRB) and warrants (NTRBW) listed on The NASDAQ Capital Market since October 1, 2021[174](index=174&type=chunk) - As of April 15, 2022, there were approximately **83 holders of record** for common stock[175](index=175&type=chunk) - The company has not declared and does not anticipate declaring cash dividends in the foreseeable future[176](index=176&type=chunk) Issuer Purchases of Equity Securities (December 2021) | Period | Total Shares Purchased | Average Price Paid Per Share | Total Shares Purchased as Part of Publicly Announced Plans | Maximum Number (or Approximate Dollar Value) of Shares That May Yet to Be Purchased | | :--- | :--- | :--- | :--- | :--- | | December 2021 | 28,125 | $3.71 | 28,125 | $895,000 | [[Reserved]](index=38&type=section&id=Item%206.%20%5BReserved%5D) This item is reserved, as the company, being a smaller reporting company, is not required to provide the information - Item 6 is reserved as the company is a smaller reporting company and not required to provide this information[181](index=181&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=39&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section reviews Nutriband Inc.'s financial condition and operational results, highlighting its shift to pharmaceutical development, capital requirements, and improved liquidity - Primary business focus is on developing transdermal pharmaceutical products, particularly the AVERSA abuse-deterrent fentanyl system, and contract services[184](index=184&type=chunk)[185](index=185&type=chunk) - The company's ability to continue operations is contingent on raising significant financing or entering joint venture agreements[185](index=185&type=chunk) [Overview](index=39&type=section&id=Overview) The company's core business is developing transdermal pharmaceutical products, with AVERSA™ fentanyl as its lead, requiring significant financing for continued development - The company's primary business is developing transdermal pharmaceutical products, with AVERSA™ abuse-deterrent fentanyl transdermal system as the lead product, protected by a recent US patent[184](index=184&type=chunk) - The business focus shifted from consumer transdermal products to pharmaceutical development after the 4P Therapeutics acquisition (August 2018) and now includes contract manufacturing services from Pocono (August 2020)[187](index=187&type=chunk)[188](index=188&type=chunk) - Significant financing or joint venture agreements are required for continued development, with a budgeted **$5.0 million** for AVERSA fentanyl R&D, though total costs could exceed this[185](index=185&type=chunk)[190](index=190&type=chunk) [Results of Operations (Years Ended January 31, 2022 and 2021)](index=41&type=section&id=Years%20Ended%20January%2031,%202022%20and%202021) Revenue increased by 50.7% in FY2022, but net loss significantly widened due to a goodwill impairment charge and higher operating expenses Consolidated Statements of Operations and Comprehensive Loss | Metric | Year Ended Jan 31, 2022 | Year Ended Jan 31, 2021 | | :--- | :--- | :--- | | Revenue | $1,422,154 | $943,702 | | Cost of Revenues | $917,844 | $627,378 | | Gross Margin | $504,310 | $316,324 | | Research and Development Expenses | $411,383 | $- | | Goodwill Impairment | $2,180,836 | $- | | Selling, General and Administrative Expenses | $4,022,824 | $2,912,269 | | Loss from Operations | $(6,110,733) | $(2,595,945) | | Net Loss | $(6,176,126) | $(2,932,828) | | Net Loss Attributable to Common Shareholders | $(6,372,715) | $(2,932,828) | | Net Loss Per Share (Basic and Diluted) | $(0.94) | $(0.51) | | Weighted Average Shares Outstanding | 6,799,624 | 5,770,944 | - Revenue increased by **50.7%** from **$943,702** in FY2021 to **$1,422,154** in FY2022, primarily driven by sales from the Pocono acquisition (**$1,093,200**) and contract R&D services (**$242,354**)[199](index=199&type=chunk) - Net loss significantly widened from **$(2,932,828)** in FY2021 to **$(6,372,715)** in FY2022, largely due to a **$2,180,836** goodwill impairment charge related to the Pocono acquisition and increased selling, general, and administrative expenses[201](index=201&type=chunk)[202](index=202&type=chunk)[206](index=206&type=chunk) - Research and development expenses commenced in FY2022, totaling **$411,383**, including **$144,000** in salary liabilities paid with common stock[203](index=203&type=chunk) [Liquidity and Capital Resources](index=42&type=section&id=Liquidity%20and%20Capital%20Resources) Liquidity significantly improved in FY2022 due to proceeds from a public offering and warrant exercises, resolving prior going concern doubts Liquidity and Capital Resources Summary | Metric | As of Jan 31, 2022 | As of Jan 31, 2021 | | :--- | :--- | :--- | | Cash and Cash Equivalents | $4,891,868 | $151,993 | | Working Capital | $4,686,112 | $(2,254,418) | | Net Cash Used in Operating Activities | $(2,809,223) | $(297,055) | | Net Cash Provided by Financing Activities | $7,630,693 | $371,873 | | Proceeds from Public Offering & Warrant Exercises (FY2022) | ~$8.8 million | - | - The company's liquidity significantly improved, with cash and cash equivalents increasing from **$151,993** in FY2021 to **$4,891,868** in FY2022, and working capital shifting from a deficit to a surplus[207](index=207&type=chunk) - This improvement was primarily driven by approximately **$8.8 million** in proceeds from a public offering and warrant exercises during FY2022, which also allowed for the retirement of most debt[207](index=207&type=chunk)[210](index=210&type=chunk)[213](index=213&type=chunk) - The substantial doubt about the company's going concern status has been resolved due to positive cash flow, positive working capital, and management's plans including increased sales commitments and debt retirement[213](index=213&type=chunk)[255](index=255&type=chunk) [Off Balance Sheet Arrangements](index=42&type=section&id=Off%20Balance%20Sheet%20Arrangements) The company has no off-balance sheet arrangements that materially affect its financial condition or results of operations - The company has no off-balance sheet arrangements that have or are reasonably likely to have a current or future material effect on its financial condition or results of operations[211](index=211&type=chunk) [Critical Accounting Policies](index=43&type=section&id=Critical%20Accounting%20Policies) Key accounting policies include revenue recognition, estimates, intangible assets, goodwill impairment, and stock-based compensation, with a significant goodwill impairment recorded in FY2022 - Key accounting policies include revenue recognition (Topic 606), use of estimates, accounts receivable, intangible assets (amortized over **10 years**), goodwill (tested annually for impairment), long-lived assets (reviewed for impairment), and stock-based compensation (ASC 718)[214](index=214&type=chunk)[215](index=215&type=chunk)[216](index=216&type=chunk)[217](index=217&type=chunk)[218](index=218&type=chunk)[219](index=219&type=chunk)[221](index=221&type=chunk) - Goodwill impairment of **$2,180,836** was recorded in FY2022, reducing the PCP Assets and Active Intelligence goodwill to **$3,629,813**, primarily due to the pandemic and unmet sales expectations[218](index=218&type=chunk)[269](index=269&type=chunk) - The company adopted ASU 2019-12 (Income Taxes) and ASU 2020-06 (Convertible Instruments) in FY2021, with no material impact, and does not expect ASU 2021-08 (Business Combinations) to have a material effect[284](index=284&type=chunk)[285](index=285&type=chunk)[286](index=286&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=44&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Nutriband Inc. is not required to provide quantitative and qualitative disclosures about market risk - The company is a smaller reporting company and is not required to provide quantitative and qualitative disclosures about market risk[222](index=222&type=chunk) [Financial Statements and Supplementary Data](index=45&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section presents the audited consolidated financial statements for FY2022 and FY2021, confirming fair presentation in GAAP, with critical audit matters noted for asset impairment - The consolidated financial statements for January 31, 2022 and 2021, are presented in conformity with GAAP, as audited by Sadler, Gibb & Associates, LLC[227](index=227&type=chunk) - Critical audit matters included the evaluation of impairment analyses for long-lived assets and goodwill, due to significant estimates and assumptions in cash flow models[232](index=232&type=chunk)[234](index=234&type=chunk)[235](index=235&type=chunk) [Report of Independent Registered Public Accounting Firm](index=46&type=section&id=Report%20of%20Independent%20Registered%20Public%20Accounting%20Firm(PCAOB%20ID:%203627)) Sadler, Gibb & Associates, LLC audited the consolidated financial statements, expressing a fair presentation opinion while highlighting critical audit matters regarding asset impairment - Sadler, Gibb & Associates, LLC audited the consolidated financial statements for the years ended January 31, 2022 and 2021, expressing an opinion that they present fairly, in all material respects, the financial position and results of operations[227](index=227&type=chunk) - Critical audit matters identified were the evaluation of impairment analyses for long-lived assets and goodwill, due to significant estimates and assumptions in management's cash flow models[232](index=232&type=chunk)[233](index=233&type=chunk)[234](index=234&type=chunk)[235](index=235&type=chunk) [Consolidated Balance Sheets](index=48&type=section&id=Consolidated%20Balance%20Sheets%20at%20January%2031,%202022%20and%202021) Cash and cash equivalents significantly increased in FY2022, contributing to higher total assets and stockholders' equity, while goodwill decreased due to impairment Consolidated Balance Sheet Summary | Metric | January 31, 2022 | January 31, 2021 | | :--- | :--- | :--- | | **ASSETS** | | | | Cash and cash equivalents | $4,891,868 | $151,993 | | Total Current Assets | $5,465,368 | $314,188 | | Property & Equipment-net | $979,297 | $1,076,626 | | Goodwill | $5,349,039 | $7,529,875 | | Intangible assets-net | $926,913 | $1,006,730 | | TOTAL ASSETS | $12,739,660 | $9,927,419 | | **LIABILITIES** | | | | Total Current Liabilities | $779,256 | $2,568,606 | | Total Liabilities | $880,375 | $2,815,473 | | **STOCKHOLDERS' EQUITY** | | | | Total Stockholders' Equity | $11,859,285 | $7,111,946 | | TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $12,739,660 | $9,927,419 | - Cash and cash equivalents increased significantly from **$151,993** in FY2021 to **$4,891,868** in FY2022, contributing to a substantial increase in total current assets[239](index=239&type=chunk) - Goodwill decreased from **$7,529,875** in FY2021 to **$5,349,039** in FY2022, reflecting an impairment charge of **$2,180,836**[239](index=239&type=chunk)[218](index=218&type=chunk) - Total liabilities decreased substantially from **$2,815,473** in FY2021 to **$880,375** in FY2022, while total stockholders' equity increased from **$7,111,946** to **$11,859,285**[239](index=239&type=chunk) [Consolidated Statements of Operations and Comprehensive Loss](index=49&type=section&id=Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss%20for%20the%20years%20ended%20January%2031,%202022%20and%202021) Revenue increased by 50.7% in FY2022, but net loss attributable to common shareholders more than doubled due to goodwill impairment and higher SG&A expenses Consolidated Statements of Operations and Comprehensive Loss | Metric | Year Ended Jan 31, 2022 | Year Ended Jan 31, 2021 | | :--- | :--- | :--- | | Revenue | $1,422,154 | $943,702 | | Cost of Revenues | $917,844 | $627,378 | | Gross Profit | $504,310 | $316,324 | | Research and Development Expenses | $411,383 | $- | | Goodwill Impairment | $2,180,836 | $- | | Selling, General and Administrative Expenses | $4,022,824 | $2,912,269 | | Loss from Operations | $(6,110,733) | $(2,595,945) | | Net Loss | $(6,176,126) | $(2,932,828) | | Net Loss Attributable to Common Shareholders | $(6,372,715) | $(2,932,828) | | Net Loss Per Share (Basic and Diluted) | $(0.94) | $(0.51) | | Weighted Average Shares Outstanding | 6,799,624 | 5,770,944 | - Revenue increased by **50.7%** year-over-year, from **$943,702** in FY2021 to **$1,422,154** in FY2022[240](index=240&type=chunk) - Net loss attributable to common shareholders more than doubled, from **$(2,932,828)** in FY2021 to **$(6,372,715)** in FY2022, primarily due to a **$2,180,836** goodwill impairment and higher SG&A expenses[240](index=240&type=chunk) [Consolidated Statements of Stockholders' Equity](index=50&type=section&id=Consolidated%20Statements%20of%20Changes%20in%20Stockholder's%20Equity%20(Deficit)%20for%20the%20years%20ended%20January%2031,%202022%20and%202021) Total Stockholders' Equity increased significantly in FY2022, driven by proceeds from public offerings and warrant exercises, despite an increased accumulated deficit - Total Stockholders' Equity increased from **$7,111,946** in FY2021 to **$11,859,285** in FY2022, driven by proceeds from public offerings, warrant exercises, and common stock issuances[242](index=242&type=chunk)[243](index=243&type=chunk) - Significant equity activities in FY2022 included **$5,836,230** from a public offering, **$2,942,970** from warrant exercises, and various common stock issuances for services and debt settlement[242](index=242&type=chunk) - Accumulated deficit increased from **$(11,835,105)** to **$(18,011,231)** due to the net loss for the year[242](index=242&type=chunk) [Consolidated Statements of Cash Flows](index=52&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows%20for%20the%20years%20ended%20January%2031,%202022%20and%202021) Net cash used in operating activities increased in FY2022, but net cash provided by financing activities significantly improved liquidity, resulting in a substantial cash balance Consolidated Statements of Cash Flows Summary | Cash Flow Activity | Year Ended Jan 31, 2022 | Year Ended Jan 31, 2021 | | :--- | :--- | :--- | | Net Cash Used In Operating Activities | $(2,809,223) | $(297,055) | | Net Cash Provided by (used in) Investing Activities | $(81,595) | $66,994 | | Net Cash Provided by Financing Activities | $7,630,693 | $371,873 | | Net Change in Cash | $4,739,875 | $141,812 | | Cash and Cash Equivalents - End of Period | $4,891,868 | $151,993 | - Net cash used in operating activities increased to **$(2,809,223)** in FY2022 from **$(297,055)** in FY2021, despite higher revenue, due to increased expenses and goodwill impairment[245](index=245&type=chunk) - Net cash provided by financing activities significantly increased to **$7,630,693** in FY2022, primarily from **$5,836,230** in public offering proceeds and **$2,942,970** from warrant exercises[245](index=245&type=chunk) - The company ended FY2022 with **$4,891,868** in cash and cash equivalents, a substantial increase from **$151,993** in FY2021[245](index=245&type=chunk) [Notes to Consolidated Financial Statements](index=54&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) The notes detail accounting policies, the Pocono acquisition and goodwill impairment, resolution of going concern status, revenue breakdown, and significant financing activities - The notes detail the company's organization, significant accounting policies (including revenue recognition, goodwill, and stock-based compensation), and recent accounting standards adoption[248](index=248&type=chunk)[255](index=255&type=chunk)[258](index=258&type=chunk)[268](index=268&type=chunk)[269](index=269&type=chunk)[272](index=272&type=chunk)[284](index=284&type=chunk)[285](index=285&type=chunk)[286](index=286&type=chunk) - The acquisition of Pocono Coated Products on August 31, 2020, for **$7,418,073** (common stock and promissory note) resulted in the recognition of **$5,810,640** in goodwill, which was later impaired by **$2,180,836** in FY2022[288](index=288&type=chunk)[291](index=291&type=chunk)[269](index=269&type=chunk) - The company's going concern status is resolved due to improved liquidity from a public offering and warrant exercises, allowing debt retirement and increased sales commitments[255](index=255&type=chunk) Revenue by Type and Geographic Location | Revenue Type | FY2022 | FY2021 | | :--- | :--- | :--- | | Sale of goods | $1,179,620 | $737,519 | | Services | $242,534 | $206,183 | | **Total Revenue** | **$1,422,154** | **$943,702** | | Geographic Location | FY2022 | FY2021 | | :--- | :--- | :--- | | United States | $1,335,554 | $360,378 | | Foreign | $86,600 | $583,324 | | **Total Revenue** | **$1,422,154** | **$943,702** | - Intangible assets, including intellectual property and customer base, are amortized over **ten years**, with amortization expense of **$129,817** in FY2022[268](index=268&type=chunk)[310](index=310&type=chunk) - The company has a net operating loss (NOL) carryforward of approximately **$7,700,000** as of January 31, 2022, fully offset by a valuation allowance[296](index=296&type=chunk) - Significant financing activities include a public offering in October 2021 (**$5,836,230** net proceeds) and warrant exercises (**$2,942,970** proceeds), which helped repay a **$1,500,000** related party note[197](index=197&type=chunk)[299](index=299&type=chunk)[302](index=302&type=chunk) - The company signed a feasibility agreement with Kindeva Drug Delivery in January 2022 to develop AVERSA Fentanyl, with an estimated cost of **$1.7 million** over **8-12 months**[345](index=345&type=chunk)[347](index=347&type=chunk) - Development of the RAMBAM Closed System Transfer Device (CSTD) has been suspended due to preliminary reviews finding it not commercially viable[342](index=342&type=chunk) [Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](index=75&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) This item states that there have been no changes in or disagreements with accountants on accounting and financial disclosure - No changes in or disagreements with accountants on accounting and financial disclosure[351](index=351&type=chunk) [Controls and Procedures](index=75&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that disclosure controls were ineffective as of January 31, 2022, due to material weaknesses, but has implemented improvements - Disclosure controls and procedures were not effective as of January 31, 2022, due to limited internal audit function, small staff, and recent acquisitions[351](index=351&type=chunk) - Material weaknesses in internal control over financial reporting include lack of segregation of duties, inadequate review of financial statements and complex transactions, and excessive reliance on third-party consultants[352](index=352&type=chunk) - Management has implemented improvements by adding qualified accounting personnel and establishing additional monitoring controls, expressing confidence that financial statements fairly present the company's condition[353](index=353&type=chunk) - No material changes in internal control over financial reporting occurred during the quarter ended January 31, 2022[355](index=355&type=chunk) [Other Information](index=75&type=section&id=Item%209B.%20Other%20Information) This item states that there is no other information to report - No other information to report[356](index=356&type=chunk) [Disclosure Regarding Foreign Jurisdictions that Prevent Inspections](index=75&type=section&id=Item%209C.%20Disclosure%20Regarding%20Foreign%20Jurisdictions%20that%20Prevent%20Inspections%2E) This item states that disclosure regarding foreign jurisdictions that prevent inspections is not applicable - Disclosure regarding foreign jurisdictions that prevent inspections is not applicable[357](index=357&type=chunk) [PART III](index=76&type=section&id=PART%20III) [Directors, Executive Officers and Corporate Governance](index=76&type=section&id=Item%2010.%20Directors,%20Executive%20Officers%20and%20Corporate%20Governance) This section provides information on Nutriband Inc.'s executive officers and directors, corporate governance structure, board leadership, and committee functions Executive Officers and Directors | Name | Age | Position | | :--- | :--- | :--- | | Gareth Sheridan | 32 | Chief Executive Officer and Director | | Serguei Melnik | 49 | Chairman of the Board and President | | Gerald Goodman | 74 | Chief Financial Officer | | Alan Smith, Ph.D. | 56 | Chief Operating Officer and President of 4P Therapeutics | | Patrick Ryan | 36 | Chief Technical Officer | | Jeff Patrick, Pharm.D. | 52 | Chief Scientific Officer | | Larry Dillaha, MD | 57 | Chief Medical Officer | | Radu Bujoreanu | 52 | Director | | Mark Hamilton | 37 | Director | | Stefan Mancas | 45 | Director | | Irina Gram | 34 | Director | - Gareth Sheridan is CEO and founder, Serguei Melnik is President and expected Chairman, and Gerald Goodman is CFO[359](index=359&type=chunk)[361](index=361&type=chunk)[368](index=368&type=chunk) - The Board of Directors consists of nine members, with five independent directors, and oversees risk through interaction with management[377](index=377&type=chunk) - Three standing committees (audit, compensation, and nominating/corporate governance) are chaired and composed entirely of independent directors[375](index=375&type=chunk)[379](index=379&type=chunk)[380](index=380&type=chunk)[381](index=381&type=chunk)[383](index=383&type=chunk) - The company has adopted a code of ethics applicable to employees, directors, and officers, available on its website[388](index=388&type=chunk) [Executive Compensation](index=82&type=section&id=Item%2011.%20Executive%20Compensation) This section details compensation for named executive officers and non-employee directors, including salaries, bonuses, stock awards, and new employment agreement terms Executive Compensation Table (FY2022 & FY2021) | Name and Principal Position | Year | Salary ($) | Bonus ($) | Stock Awards ($) | Option/Awards ($) | Total ($) | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Gareth Sheridan, CEO | 2022 | 149,000 | 100,000 | - | 61,778 | 310,770 | | | 2021 | 60,000 | - | 150,000 | - | 210,000 | | Serguei Melnik, President | 2022 | 149,000 | 100,000 | - | 61,778 | 310,770 | | Alan Smith, COO | 2022 | 148,000 | - | - | 32,654 | 264,654 | Non-Employee Director Compensation (FY2022) | Name | Fees Earned or Paid in Cash ($) | Option Awards ($) | Total ($) | | :--- | :--- | :--- | :--- | | Mark Hamilton | 5,000 | 29,340 | 34,340 | | Sean Gallagher | 5,000 | 32,500 | 37,500 | | Radu Bujourneau | 5,000 | 26,120 | 31,120 | | Stefani Mancas | 5,000 | 21,222 | 26,222 | | Steven Damon | 5,000 | 16,325 | 21,325 | | Vselovod Grigore | 5,000 | 16,325 | 21,325 | - New employment agreements effective February 1, 2022, for CEO Gareth Sheridan and President Serguei Melnik include annual salaries of **$250,000** each and a performance bonus based on net operating profit before income taxes[340](index=340&type=chunk)[401](index=401&type=chunk) - CFO Gerald Goodman's new employment agreement includes an annual salary of **$210,000**[341](index=341&type=chunk)[401](index=401&type=chunk) - In case of termination without cause or for good reason, executives are entitled to lump-sum payments including salary, bonuses, and accelerated vesting of stock options and warrants[402](index=402&type=chunk)[403](index=403&type=chunk) - The company currently has no pension plans for officers[410](index=410&type=chunk) [Security Ownership of Certain Beneficial Owners and Management](index=86&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) This section details beneficial ownership of common stock by directors, executive officers, and principal stockholders, highlighting their significant collective voting power Beneficial Ownership of Common Stock (as of April 22, 2022) | Name | Shares of Common Stock Owned Directly | Shares of Derivative Securities Owned | Total Beneficial Ownership Including Option Grants | Percentage | | :--- | :--- | :--- | :--- | :--- | | Gareth Sheridan | 1,510,000 | 20,000 | 1,530,000 | 19.56% | | Serguei Melnik | 707,500 | 20,000 | 727,500 | 9.3% | | Gerald Goodman | 22,500 | 85,000 | 107,500 | 1.36% | | All officers and directors as a group (11 individuals) | 2,374,924 | 188,500 | 2,563,424 | 32.00% | - As of April 22, 2022, **7,821,176 shares** of common stock were outstanding[413](index=413&type=chunk) - Officers and directors as a group beneficially own **32.00%** of the common stock, giving them effective power to elect directors and approve stockholder actions[414](index=414&type=chunk)[157](index=157&type=chunk) - No contracts or arrangements are known that would result in a change in control of the company[420](index=420&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=87&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions,%20and%20Director%20Independence) This section outlines related party transactions, primarily stock option and common stock issuances to directors and executive officers as compensation, and notes director independence - In FY2021, **51,825 shares** of common stock (valued at **$777,375**) were issued to executive officers and **78,500 shares** (valued at **$1,177,500**) to current and former independent directors as compensation[322](index=322&type=chunk)[323](index=323&type=chunk)[424](index=424&type=chunk) - On January 21, 2022, the Board approved stock option awards under the 2021 Employee Stock Option Plan to officers and directors for services rendered in fiscal 2022, with exercise prices of **$4.85** or **$5.34 per share**[426](index=426&type=chunk)[427](index=427&type=chunk) - Four directors (Radu Bujoreanu, Mark Hamilton, Dr. Mancas, and Irina Gram) are considered independent based on NASDAQ definitions[384](index=384&type=chunk) [Principal Accounting Fees and Services](index=88&type=section&id=Item%2014.%20Principal%20Accounting%20Fees%20and%20Services) This section details fees paid to the independent accountants for audit and other services for FY2022 and FY2021, all pre-approved by the audit committee Principal Accounting Fees and Services | Fee Type | Year Ended Jan 31, 2022 ($) | Year Ended Jan 31, 2021 ($) | | :--- | :--- | :--- | | Audit fees | 69,250 | 63,500 | | Audit – related fees | 12,200 | - | | Tax fees | - | - | | All other fees | - | 65,637 | - Audit fees increased from **$63,500** in FY2021 to **$69,250** in FY2022. Audit-related fees of **$12,200** were incurred in FY2022, while 'All other fees' decreased from **$65,637** in FY2021 to **$0** in FY2022[429](index=429&type=chunk) - All audit and permissible non-audit services performed by the independent accountants were pre-approved by the audit committee[431](index=431&type=chunk) [PART IV](index=89&type=section&id=PART%20IV) [Exhibits and Financial Statement Schedules](index=89&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section lists all exhibits filed with the Form 10-K, including corporate documents, various agreements, stock plans, and required certifications - The report includes various exhibits such as Articles of Incorporation, By-laws, Securities Purchase Agreements, Forms of Warrants, Stock Option Plans, and key Employment Agreements[434](index=434&type=chunk) - Certifications from the Principal Executive Officer and Principal Financial Officer, as required by the Sarbanes-Oxley Act, are also included[434](index=434&type=chunk) - Inline XBRL documents for the instance, schema, calculation, definition, label, and presentation linkbases are provided[434](index=434&type=chunk) [Form 10-K Summary](index=91&type=section&id=Item%2016.%20Form%2010-K%20Summary) This item states that a Form 10-K Summary is not applicable - Form 10-K Summary is not applicable[437](index=437&type=chunk) [Signatures](index=92&type=section&id=SIGNATURES) The report is signed by the Chief Executive Officer, Chief Financial Officer, and other directors on April 28, 2022 - The report is signed by Gareth Sheridan (Chief Executive Officer and Director), Gerald Goodman (Chief Financial Officer), Serguei Melnik (Director), Radu Bujoreanu (Director), Mark Hamilton (Director), Stefan Mancas (Director), and Irina Gram (Director)[442](index=442&type=chunk) - The report was signed on April 28, 2022[441](index=441&type=chunk)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended October 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________ to __________ Commission File Number 000-55654 NUTRIBAND INC. (Exact name of registrant as specified in its charter) | NEVADA | 81-1118176 | | --- | --- | | (Stat ...

Revenue Performance - Total revenue for the three months ended July 31, 2021, was $213,739, a 153% increase compared to $84,450 for the same period in 2020[13]. - Total revenue for the six months ended July 31, 2021, reached $647,227, up 218% from $203,814 in the same period of 2020[13]. - Revenue from the sale of goods for the six months ended July 31, 2021, was $541,251, up from $120,770 in 2020, indicating an increase of 348%[41]. - For the three months ended July 31, 2021, total revenue was $213,739, compared to $84,450 for the same period in 2020, representing a growth of 152%[41]. - For the six months ended July 31, 2021, the company generated revenue of $647,227, up from $203,814 in the same period in 2020, resulting in a gross margin of $291,621 compared to $11,938 in 2020[121]. Net Loss and Expenses - Net loss for the three months ended July 31, 2021, was $519,923, compared to a net loss of $225,869 for the same period in 2020, representing a 130% increase in losses[13]. - Net loss for the six months ended July 31, 2021, was $835,880, an increase of 31% from a net loss of $638,063 in the same period of 2020[13]. - Selling, general and administrative expenses for the three months ended July 31, 2021, were $509,219, a significant increase from $193,331 in the same period of 2020[13]. - Selling, general and administrative expenses for the six months ended July 31, 2021, were $1,088,827, an increase from $355,248 in the same period in 2020, primarily due to non-cash consulting expenses and expenses from Active Intelligence[122]. Assets and Liabilities - Total current assets as of July 31, 2021, were $606,750, compared to $314,188 as of January 31, 2021, reflecting a 93% increase[11]. - Total assets increased to $10,163,555 as of July 31, 2021, from $9,927,419 as of January 31, 2021, marking a 2.4% growth[11]. - Total liabilities as of July 31, 2021, were $2,847,489, slightly up from $2,815,473 as of January 31, 2021[11]. - Stockholders' equity increased to $7,316,066 as of July 31, 2021, from $7,111,946 as of January 31, 2021, indicating a 2.9% rise[11]. Cash Flow and Financing - Cash used in operating activities was $367,944 for the six months ended July 31, 2021, compared to $313,652 for the same period in 2020, indicating a 17% increase in cash outflow[18]. - The company reported net cash provided by financing activities of $569,605 for the six months ended July 31, 2021, compared to $342,719 for the same period in 2020, reflecting a 66% increase in financing cash flow[18]. - Cash and cash equivalents at the end of the period were $304,258, significantly up from $39,248 at the end of the same period in 2020, marking an increase of over 675%[18]. - The company incurred stock-based compensation expenses of $225,000 for the six months ended July 31, 2021, compared to $38,000 in the same period in 2020, which is an increase of approximately 493%[18]. Acquisitions and Investments - The acquisition of 4P Therapeutics LLC for $2,250,000 included a royalty of 6% on all revenue generated from the abuse deterrent intellectual property developed by 4P Therapeutics[22]. - The company acquired net assets valued at $7,418,073 from Pocono Coated Products and Active Intelligence, including $6,085,180 in common stock issued and a note payable of $1,332,893[59]. - The company acquired Advanced Health Brands, Inc. for 1,250,000 shares of common stock valued at $2,500,000[89]. - The company purchased assets from Pocono Coated Products for $6,000,000 in common stock and a $1,500,000 promissory note[97]. Regulatory and Compliance - The company recognizes revenue based on the five criteria established under Topic 606, ensuring compliance with revenue recognition standards[36]. - The company has implemented plans to alleviate substantial doubt about its ability to continue as a going concern, including increasing sales commitments and reducing overhead expenses[31]. - The company has established additional monitoring controls over financial statements and added qualified accounting personnel to reduce reliance on third-party consultants[144]. - The SEC accepted a settlement offer from the company and its officers for violations related to inaccurate statements in SEC filings, resulting in cease-and-desist orders[150]. Product Development and Market Position - The company is focused on developing transdermal pharmaceutical products, which are currently in the preclinical stage and require FDA approval before marketing[24]. - The company is seeking FDA approval for its transdermal pharmaceutical products, which is a time-consuming and expensive process[111]. - The company has suspended its pharmaceutical product development operations due to a lack of funds, which is critical for the development of transdermal systems for pharmaceuticals[154]. - The company has not completed the development of its lead product, the abuse deterrent fentanyl transdermal system, and lacks any marketable product in the United States[156]. Leadership and Governance - Nutriband Inc. is represented by Gareth Sheridan as the Chief Executive Officer and Gerald Goodman as the Chief Financial Officer, indicating leadership stability[164]. - The CEO's annual salary is set at $42,000, increasing to $170,000 upon raising at least $2,500,000 in equity financing[92]. Miscellaneous - The company recorded no bad debt expense for doubtful accounts related to accounts receivable for the six months ended July 31, 2021, and 2020[42]. - The company has no long-term contractual obligations and can terminate contracts at any time[110]. - The company has filed various certifications including Section 302 and Section 906 by the Chief Executive Officer and Chief Financial Officer, ensuring compliance with regulatory requirements[31][32][33]. - The report includes XBRL documents which facilitate the analysis and sharing of financial data, enhancing transparency and accessibility for investors[101].