Core Insights - Nutriband Inc. has signed an Associate Partnership agreement with Charlotte FC to enhance brand visibility, particularly for its AI Tape product manufactured locally in Charlotte [1][2] - The partnership aims to promote Nutriband's AVERSA platform technology, which is positioned as a potential first-of-its-kind abuse deterrent patch for chronic pain management [3] - Nutriband is focused on developing a portfolio of transdermal pharmaceutical products, with its lead product being an abuse deterrent fentanyl patch utilizing AVERSA technology [4] Company Overview - Nutriband Inc. specializes in transdermal pharmaceutical products, with a manufacturing facility located in North Carolina [2][4] - The AVERSA technology is designed to prevent the abuse, misuse, diversion, and accidental exposure of drugs with abuse potential, and can be integrated into any transdermal patch [4]

Core Points - Nutriband Inc. has received trademark registration for "Nutriband™" from the USPTO, which is crucial for the commercialization of its AVERSA technology [1][2] - The AVERSA technology aims to prevent the abuse and misuse of drugs, with the lead product being AVERSA™ Fentanyl, a transdermal system designed to deter abuse [2][6] - Nutriband is collaborating with Kindeva Drug Delivery to scale up the commercial manufacturing process for AVERSA™ Fentanyl, which is intended for FDA approval [3] - A market analysis indicates that AVERSA™ Fentanyl could achieve peak annual U.S. sales between $80 million and $200 million, highlighting the potential market impact of the technology [4] - The AVERSA™ technology incorporates aversive agents into transdermal patches to deter drug abuse, particularly for high-abuse-potential medications like fentanyl [5] - Nutriband is focused on developing a range of transdermal pharmaceutical products, with a strong intellectual property portfolio supporting its AVERSA technology [6]

Core Insights - Nutriband has formalized an exclusive product development partnership with Kindeva Drug Delivery to develop Aversa™ Fentanyl, which integrates Nutriband's abuse-deterrent technology with Kindeva's FDA-approved fentanyl patch [1][2] - The partnership involves shared development costs in exchange for milestone payments, indicating a long-term commitment between the two companies [2] Company Overview - Nutriband is focused on developing prescription transdermal pharmaceutical products, with Aversa™ Fentanyl being its lead product under development [5] - The Aversa™ technology aims to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential, particularly opioids and stimulants [2][4] Technology Details - Aversa™ abuse-deterrent technology employs a proprietary aversive agent coating that utilizes taste aversion to deter oral abuse and accidental exposure to transdermal opioid and stimulant patches [3] - The technology is protected by a broad international intellectual property portfolio, with patents issued in 46 countries, including the United States, Europe, Japan, and China [3][4] Market Potential - Aversa™ Fentanyl has the potential to be the world's first abuse-deterrent opioid patch, with projected peak annual U.S. sales estimated between $80 million and $200 million [4]

Core Viewpoint - Nutriband Inc. has appointed Olympic medalist Anastasia Nichita to its Product Advisory Board to enhance the brand and promote its sports and consumer products internationally [1][2]. Group 1: Company Overview - Nutriband Inc. specializes in the development of transdermal pharmaceutical products, with a focus on an abuse deterrent fentanyl patch utilizing AVERSA™ technology [4]. - The company produces various products through its subsidiary Pocono Pharma, including AI Tape, which combines traditional kinesiology tape benefits with therapeutic ingredients [3]. Group 2: Strategic Initiatives - The addition of Anastasia Nichita is expected to provide valuable insights and experience to strengthen Nutriband's consumer product categories globally [2].

Core Viewpoint - Nutriband Inc. has received a Notice of Allowance from the USPTO for its patent application related to the Aversa™ abuse deterrent technology, which is expected to enhance its intellectual property protection in the U.S. for transdermal products aimed at preventing drug abuse and misuse [1][2][4]. Group 1: Technology Overview - The Aversa™ abuse deterrent technology incorporates aversive agents into transdermal patches to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential, including opioids and stimulants [3][6]. - This technology employs a proprietary aversive agent coating that utilizes taste aversion to deter oral abuse and accidental exposure to transdermal products [3][6]. Group 2: Product Development - Nutriband's lead product under development is Aversa™ Fentanyl, which aims to be the first abuse deterrent fentanyl transdermal system on the market [2][5]. - Aversa™ Fentanyl has the potential to achieve peak annual U.S. sales ranging from $80 million to $200 million [5]. Group 3: Intellectual Property - The Aversa™ technology is protected by a broad international intellectual property portfolio, with patents issued in 46 countries, including the U.S., Europe, Japan, Korea, Russia, China, Canada, Mexico, and Australia [1][4][6].

Core Insights - Nutriband is planning to file for FDA approval for its AVERSA™ Fentanyl product in the first half of 2025 [1] - The AVERSA™ technology aims to deter abuse and misuse of transdermal fentanyl patches, potentially improving safety for patients [4][11] - The technology is protected by a broad intellectual property portfolio with patents granted in 46 countries, including major markets [10][15] Company Developments - Nutriband is collaborating with Kindeva Drug Delivery to develop AVERSA™ Fentanyl, which integrates Nutriband's abuse-deterrent technology into an FDA-approved transdermal system [3] - The company has completed the registration requirements to extend its Chinese patent to Macao, enhancing its intellectual property protection [9] - AVERSA™ Fentanyl is projected to achieve peak annual sales in the U.S. ranging from $80 million to $200 million [12] Technology Overview - The AVERSA™ abuse-deterrent technology incorporates aversive agents into transdermal patches to prevent drug abuse and accidental exposure [4][11] - This technology is designed to maintain accessibility for patients who genuinely need these medications while reducing the risk of misuse [4][11] - The technology's broad patent coverage includes regions such as Hong Kong and Macao, in addition to other major markets [10][15]

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].