Revenue and Financial Performance - Revenue for the three months ended October 31, 2024, was $645,796, representing a 50.9% increase from $427,841 in the same period of 2023[15]. - Total revenue for the nine months ended October 31, 2024, was $1,497,158, compared to $1,560,701 for the same period in 2023, representing a decrease of approximately 4.05%[47]. - Revenue from the sale of goods was $1,497,158 for the nine months ended October 31, 2024, compared to $1,395,667 for the same period in 2023, indicating an increase of approximately 7.27%[47]. - For the three months ended October 31, 2024, the net loss was $1,362,637, compared to a net loss of $1,759,946 for the same period in 2023, representing a decrease of approximately 22.5%[17][18]. - The company reported a net loss from operations of $4,726,060 for the nine months ended October 31, 2024, compared to a net loss of $3,604,348 for the same period in 2023, indicating an increase in operational losses[21][34]. Assets and Liabilities - Total current assets increased to $6,191,602 as of October 31, 2024, compared to $1,021,863 as of January 31, 2024[13]. - Total liabilities as of October 31, 2024, were $1,311,503, compared to $1,078,919 as of January 31, 2024, showing a 21.5% increase[13]. - Cash and cash equivalents increased to $5,698,187 as of October 31, 2024, from $492,942 as of January 31, 2024[13]. - The total working capital as of October 31, 2024, was $4,934,816, compared to a working capital deficit of $(26,099,053) as of October 31, 2023, reflecting a substantial turnaround[18][34]. - As of October 31, 2024, the company had cash and cash equivalents of $5,698,187, an increase from $1,265,323 as of October 31, 2023, indicating a significant improvement in liquidity[21][34]. Research and Development - Research and development expenses for the three months ended October 31, 2024, were $880,768, up from $551,503 in the same period of 2023, indicating a 59.6% increase[15]. - Research and development expenses for the Aversa Fentanyl product totaled $2,629,278 for the nine months ended October 31, 2024, an increase of 88.5% from $1,397,055 for the same period in 2023[165]. - The company is focused on developing transdermal pharmaceutical products, with a primary emphasis on incorporating its Aversa abuse deterrent technology into existing approved drugs[26]. - The company requires approximately $13 million for research and development of its abuse deterrent fentanyl transdermal system, which includes clinical manufacturing and clinical trials[147]. - The company has entered into a commercial development agreement with Kindeva Drug Delivery for Aversa Fentanyl, with an estimated cost of $8.1 million for completion[129]. Financing and Capital Structure - The company raised $8,400,000 from equity financing with European investors on April 19, 2024, which will support ongoing research and development efforts[34]. - The company has relied on sales of securities and issuance of debt to support cash flow from operations, highlighting its ongoing need for external financing[34]. - The company has a credit line facility of $5,000,000, which was amended in July 2023, to fund research and development of its Aversa product[34]. - The company completed an $8,400,000 equity financing on April 19, 2024, issuing 2,100,000 units at a price of $4.00 per unit, each consisting of one share of common stock and a warrant[156]. - The company entered into an amended three-year $5,000,000 credit line facility on July 13, 2023, replacing a previous $2,000,000 facility, with drawdowns bearing interest at 7% per annum[154]. Expenses and Cost Management - Total costs and expenses for the nine months ended October 31, 2024, were $6,223,218, compared to $5,126,278 for the same period in 2023, reflecting a 21.5% increase[15]. - Operating expenses totaled $5,183,433 for the nine months ended October 2024, compared to $4,269,915 for the same period in 2023, representing an increase of approximately 21.4%[123]. - Selling, general and administrative expenses decreased to $737,102 for the three months ended October 31, 2024, down from $1,330,929 in the same period in 2023, a reduction of approximately 44%[159]. - Selling, general and administrative expenses for the nine months ended October 31, 2024, were $2,554,155, a decrease of 10.4% compared to $2,849,399 for the same period in 2023[164]. - The company recorded bad debt expenses of $1,200 for the nine months ended October 31, 2024, significantly lower than $11,836 for the same period in 2023, reflecting improved credit management[51]. Stock and Equity - The weighted average shares of common stock outstanding for the three months ended October 31, 2024, were 11,101,945, compared to 7,833,150 in the same period of 2023[15]. - The total number of outstanding options as of October 31, 2024, is 1,324,835, with an intrinsic value of $4,139,797[120]. - The company has reserved a total of 1,400,000 shares under the Employee Stock Option Plan, pending stockholder approval[115]. - The Company issued 450,000 options to purchase shares at prices ranging from $2.37 to $5.99 during the nine months ended October 31, 2024[116]. - As of October 31, 2024, there are 5,597,998 warrants outstanding with an average exercise price of $6.35 and an intrinsic value of $314,199[109]. Compliance and Governance - The company recognized revenue from contracts with customers based on five criteria established under Topic 606, ensuring compliance with updated revenue recognition standards[39]. - The company applies a "right-of-use" model for lease accounting, recording operating lease liabilities on its balance sheet in accordance with ASU 2016-02[61]. - The company utilizes fair value measurements for financial and non-financial assets and liabilities, adhering to the fair value hierarchy established by ASC 820[68]. - The Company applies the asset and liability method for income taxes, recognizing deferred tax assets and liabilities based on future tax consequences[205]. - The Company concluded that its disclosure controls and procedures are not effective in ensuring timely and accurate reporting as required by SEC rules[209].

Financial Performance - Total revenue for the three months ended July 31, 2024, was $442,830, a decrease of 32.5% compared to $655,928 for the same period in 2023[5]. - Net loss for the six months ended July 31, 2024, was $3,603,542, compared to a net loss of $1,844,402 for the same period in 2023, representing an increase in loss of 95.2%[5]. - The company generated total revenue of $851,362 for the six months ended July 31, 2024, compared to $1,132,860 for the same period in 2023, representing a decrease of approximately 25%[31]. - For the six months ended July 31, 2024, the company incurred a net loss from operations of $3,603,542 and used cash flow from operations of $2,377,673[19]. - For the three months ended July 31, 2024, the net loss was $1,705,465, indicating a continued trend of losses[8]. Assets and Liabilities - Total assets as of July 31, 2024, were $13,633,709, an increase from $7,517,154 as of January 31, 2024[4]. - Total current liabilities increased to $1,103,590 as of July 31, 2024, compared to $999,093 as of January 31, 2024, reflecting a rise of 10.5%[4]. - As of July 31, 2024, total assets increased to $12,460,986, with an accumulated deficit of $(31,583,561)[8]. - The total assets of the company as of July 31, 2024, were $13,633,709, an increase from $9,793,599 as of January 31, 2023, representing a growth of approximately 39%[82]. Cash and Cash Equivalents - Cash and cash equivalents as of July 31, 2024, were $6,759,967, compared to $492,942 as of January 31, 2024, indicating a significant increase[4]. - The company reported a cash and cash equivalents balance of $6,759,967 as of the end of the period, up from $2,334,553 in the previous year[10]. - As of July 31, 2024, the Company had cash and cash equivalents of $6,759,967 and working capital of $6,144,483[19]. Research and Development - Research and development expenses for the three months ended July 31, 2024, were $773,975, an increase of 73.8% from $445,122 in the same period of 2023[5]. - Research and development expenses for 4P Therapeutics rose significantly to $1,748,510 for the six months ended July 31, 2024, compared to $845,552 in the prior year, marking an increase of about 106%[81]. - The company has incurred expenses of $1,080,329 related to the commercial development and clinical manufacturing agreement with Kindeva Drug Delivery, with an estimated total cost of $8.1 million[86]. Stock and Equity - Total stockholders' equity as of July 31, 2024, was $12,460,986, up from $6,438,235 as of January 31, 2024, showing a growth of 93.5%[6]. - The company issued 2,100,000 shares of common stock for proceeds of $8,400,000 during the six months ended July 31, 2024[6]. - The Company completed an $8,400,000 equity financing with European investors, which included two related parties investing a total of $6,420,000[61]. Expenses - Operating expenses for Pocono Pharmaceuticals increased to $321,068 for the six months ended July 31, 2024, compared to $272,283 in the same period in 2023, reflecting an increase of approximately 18%[81]. - The Company recorded interest expenses of $13,637 during the six months ended July 31, 2024, compared to $12,401 for the same period in 2023[56]. - Depreciation expenses for the six months ended July 31, 2024, were $82,475, compared to $93,936 for the same period in 2023[52]. Legal and Compliance - The company is currently involved in a lawsuit seeking over $500,000 in damages, while also pursuing counterclaims for $1,000,000 against the plaintiffs[89][90]. - The company recorded a reserve for bad debts of $118,675 related to the bankruptcy proceedings from Sorrento Therapeutics Inc.[88]. Future Outlook - The company believes it will generate sufficient funds from operations to continue as a going concern for at least one year from the date of the financial statements[20]. - The estimated cost to complete the commercial development and clinical manufacturing agreement with Kindeva is approximately $8.1 million, with an expected FDA submission in twelve to eighteen months[86].

Financial Performance - For the three months ended April 30, 2024, revenue was $408,532, a decrease of 14.3% compared to $476,932 for the same period in 2023[12]. - Net loss for the three months ended April 30, 2024, was $1,898,077, compared to a net loss of $1,015,229 for the same period in 2023, representing an increase in loss of 86.7%[12]. - Revenue for the three months ended April 30, 2024, was $408,532, a decrease of 14.3% compared to $476,932 for the same period in 2023[42]. - For the three months ended April 30, 2024, net sales were $408,532 for Pocono Pharmaceuticals, compared to $401,057 in the same period of 2023[96]. - Gross profit for Pocono Pharmaceuticals was $164,786 for the three months ended April 30, 2024, down from $169,308 in 2023[96]. - Total operating expenses for the three months ended April 30, 2024, were $2,054,263, compared to $1,240,162 in the same period of 2023[96]. - The company's net loss for the three months ended April 30, 2024, was $1,898,077, or $(0.21) per share, compared to a loss of $1,015,235, or $(0.13) per share for the same period in 2023[134]. Assets and Liabilities - Total current assets increased to $8,729,940 as of April 30, 2024, compared to $1,021,863 as of January 31, 2024[10]. - Total liabilities increased to $1,791,367 as of April 30, 2024, compared to $1,078,919 as of January 31, 2024[10]. - As of April 30, 2024, the company recorded total assets of $15,154,480, with corporate assets at $8,210,779 and Pocono Pharmaceuticals at $5,044,569[98]. - As of April 30, 2024, net property and equipment amounted to $740,305, a decrease from $774,924 as of January 31, 2024[64]. - As of April 30, 2024, net intangible assets were $638,993, down from $667,280 as of January 31, 2024[71]. - Goodwill as of April 30, 2024, amounted to $5,021,713, unchanged from January 31, 2024[48]. Cash Flow and Financing - Cash and cash equivalents increased to $8,347,740 as of April 30, 2024, from $492,942 at the beginning of the period[17]. - The company reported a net cash used in operating activities of $833,926 for the three months ended April 30, 2024, compared to $749,864 for the same period in 2023[17]. - The company raised $8,400,000 from the sale of common stock and warrants during the three months ended April 30, 2024[17]. - The company generated $8,400,000 from equity financing with European investors on April 19, 2024, of which $7.12 million was from related parties[31]. - The company completed an $8,400,000 equity financing with European investors, where related parties invested a total of $7,120,000, receiving 1,780,000 shares of common stock and warrants for 3,560,000 shares[82]. - The company has relied on sales of securities and issuance of debt to support cash flow from operations since inception[31]. Research and Development - Research and development expenses rose significantly to $974,535 for the three months ended April 30, 2024, compared to $400,430 in the same period of 2023, an increase of 143.5%[12]. - Research and development expenses for 4P Therapeutics were $974,535 for the three months ended April 30, 2024, compared to $400,430 in 2023[96]. - The company incurred approximately $2,950,998 in expenses related to the feasibility Workplan for the AVERSA Fentanyl product, with an estimated total cost of $2.5 million[103]. - The company requires approximately $13 million for research and development of the abuse deterrent fentanyl transdermal system, including clinical manufacturing and trials[120]. - The company has a three-year $5,000,000 Credit Line Note facility to fund research and development of its Aversa product[31]. - Research and development costs are expensed as incurred, with no specific figures provided in the documents[55]. Operational Challenges - The company expects to continue incurring substantial losses and negative cash flow for the foreseeable future due to ongoing product development and clinical trials[183]. - The company faces significant challenges in achieving market acceptance for its products post-FDA approval, which could adversely affect its operating results and financial condition[184]. - The drug delivery industry is rapidly evolving, and the company's future success depends on its ability to keep pace with technological advancements and changing customer requirements[185]. - If FDA approval is obtained, the company anticipates facing strong competition from well-established firms with better resources and existing relationships within the healthcare system[186]. - The FDA regulatory process may be more time-consuming and costly than anticipated, with no guarantee of approval for the lead product[189]. - There is a risk that the company may not be able to launch any products even after receiving FDA marketing approval[189]. Stock and Options - The weighted average shares of common stock outstanding increased to 9,159,869 for the three months ended April 30, 2024, from 7,833,150 in the same period of 2023[12]. - The company issued 390,000 options to purchase shares at prices ranging from $2.37 to $2.61 per share during the three months ended April 30, 2024[91]. - As of April 30, 2024, there are 1,264,835 options outstanding with an average exercise price of $2.63[93]. - The company has reserved a total of 1,400,000 shares for its Employee Stock Option Plan, pending stockholder approval[90]. - The company has reserved a total of 1,400,000 shares under the 2021 Employee Stock Option Plan as of March 20, 2024[123]. Miscellaneous - The company recorded bad debt expenses of $1,200 for the three months ended April 30, 2024, compared to $0 for the same period in 2023[44]. - The company recorded a reserve for bad debts of $118,675 related to a claim from Sorrento Therapeutics, with proceeds of $106,528 received[106]. - The company has established additional monitoring controls over financial statements and improved internal controls for detailed accounting review of revenue items and accounts receivable[172]. - The company has not generated any revenue from 4P Therapeutics' products under development since the acquisition, continuing only contract research and development services[119]. - The company has entered into three-year employment agreements with key executives, with salaries reduced to $150,000 for the CEO and President, and $110,000 for the CFO as of July 31, 2022[99][100]. - The company completed the feasibility Workplan for the AVERSA product in February 2024, marking a significant milestone in its development[102].

Revenue and Financial Performance - For the year ended January 31, 2024, the company generated revenue of $2,085,314, a slight increase from $2,079,609 in the previous year, with costs of revenue at $1,223,209 compared to $1,329,200[178]. - The company reported a net loss of $5,485,314, or $(0.69) per share, for the year ended January 31, 2024, compared to a loss of $4,483,474, or $(0.53) per share, for the previous year[183]. - For the year ended January 31, 2024, the Company incurred a net loss from operations of $4,871,926 and used cash flow from operations of $3,527,509[191]. - The company’s total revenue from contract manufacturing services was $1,920,280 for the year ended January 31, 2024[178]. Expenses - The company incurred research and development expenses of $1,960,425 for its Aversa Fentanyl product, up from $982,227 in the previous year[181]. - Selling, general and administrative expenses decreased to $3,773,606 for the year ended January 31, 2024, from $3,916,041 in the prior year[179]. - The company recorded bad debt expenses of $118,364 for doubtful accounts related to accounts receivable for the year ended January 31, 2024[201]. - The company’s interest expense increased to $75,815 for the year ended January 31, 2024, compared to $6,289 in the previous year[183]. - The company recorded an impairment expense of $327,326 in the previous year due to a write-down of goodwill related to its Pocono acquisition[180]. Cash and Financing - As of January 31, 2024, the company had cash and cash equivalents of $492,942, down from $1,985,440 a year earlier[184]. - The company completed an $8,400,000 equity financing with European investors on April 19, 2024, consisting of 2,100,000 units at a price of $4.00 per unit[177]. - The Company entered into a three-year $5,000,000 Credit Line Note facility to fund research and development of its Aversa product[191]. - The Company recorded proceeds of $8,400,000 from a private placement of its common stock on April 19, 2024[191]. Inventory and Assets - As of January 31, 2024, total inventory was $168,605, a decrease from $229,335 as of January 31, 2023[204]. - Goodwill amounted to $5,021,713 as of January 31, 2024, unchanged from the previous year[207]. Future Outlook - The Company believes it will generate sufficient funds from operations to continue for one year from the date of the financial statements[192]. - The Company has generated operating losses since inception and has relied on sales of securities and debt issuance to support cash flow[191]. - Research and development costs are expensed as incurred, reflecting the Company's commitment to innovation[214]. Capital Requirements - The company has a capital requirement of approximately $13 million for the research and development of its abuse deterrent fentanyl transdermal system[169].

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)

As filed with the Securities and Exchange Commission on July 6, 2023 Registration No. 333-271791 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 2 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Nutriband Inc. (Exact name of registrant as specified in its charter) (State or jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Nevada 2834 81-1118176 (I.R.S. Employer Identification No.) Orlando, Florid ...

As filed with the Securities and Exchange Commission on June 23, 2023 Registration No. 333-271791 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 1 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Nutriband Inc. (Exact name of registrant as specified in its charter) (State or jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Nevada 2834 81-1118176 (I.R.S. Employer Identification No.) Orlando, Florida ...

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 ...

As filed with the Securities and Exchange Commission on May 10, 2023 Registration No. 333-_____ UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Nutriband Inc. (Exact name of registrant as specified in its charter) (State or jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Nevada 2834 81-1118176 (I.R.S. Employer Identification No.) 121 South Orange Ave., Suite 1500 O ...