[Part I: Financial Information](index=4&type=section&id=Part%20I%3A%20Financial%20Information) [Financial Statements](index=4&type=section&id=Item%201%20Financial%20Statements) The unaudited condensed consolidated financial statements for Q1 2025 reflect a net loss, increased revenue, and decreased assets and cash, indicating continued reliance on financing [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of April 30, 2025, total assets decreased to $6.15 million from $7.47 million, primarily due to reduced cash, while liabilities remained stable and equity decreased Condensed Consolidated Balance Sheet Highlights (in USD) | Account | April 30, 2025 (Unaudited) | January 31, 2025 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $2,964,097 | $4,311,719 | | Total Current Assets | $3,429,647 | $4,794,265 | | Goodwill | $1,719,535 | $1,719,535 | | **Total Assets** | **$6,152,181** | **$7,469,955** | | **Liabilities & Equity** | | | | Total Current Liabilities | $925,051 | $982,845 | | **Total Liabilities** | **$1,048,795** | **$1,041,050** | | **Total Stockholders' Equity** | **$5,103,386** | **$6,428,905** | [Condensed Consolidated Statements of Operations](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For the three months ended April 30, 2025, revenue increased by 63% to $667,432, with the net loss improving to $1.39 million due to lower operating expenses Consolidated Statements of Operations (in USD) | Metric | Three Months Ended April 30, 2025 | Three Months Ended April 30, 2024 | | :--- | :--- | :--- | | Revenue | $667,432 | $408,532 | | Cost of revenues | $415,451 | $243,746 | | Research and development | $683,426 | $974,535 | | Selling, general and administrative | $982,052 | $1,079,728 | | Loss from operations | $(1,413,497) | $(1,889,477) | | **Net loss** | **$(1,388,869)** | **$(1,898,077)** | | **Net loss per share (basic and diluted)** | **$(0.12)** | **$(0.21)** | [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the three months ended April 30, 2025, net cash used in operating activities increased, resulting in a $1.35 million net decrease in cash, ending the period with $2.96 million Consolidated Statements of Cash Flows (in USD) | Cash Flow Activity | Three Months Ended April 30, 2025 | Three Months Ended April 30, 2024 | | :--- | :--- | :--- | | Net Cash Used In Operating Activities | $(1,336,972) | $(833,926) | | Net Cash Used in Investing Activities | $(5,324) | $(6,195) | | Net Cash Provided by Financing Activities | $(5,326) | $8,694,919 | | **Net change in cash** | **$(1,347,622)** | **$7,854,798** | | **Cash and cash equivalents - End of period** | **$2,964,097** | **$8,347,740** | [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 business structure, accounting policies, and financial components, covering transdermal products, going concern, revenue recognition, and legal contingencies - The company's primary business is the development of transdermal pharmaceutical products, focusing on its Aversa abuse-deterrent technology, with revenue generated through Pocono Pharmaceuticals and 4P Therapeutics[21](index=21&type=chunk)[23](index=23&type=chunk)[107](index=107&type=chunk) - Management believes recent equity financing of **$8.4 million** in April 2024 and a **$5 million** related-party credit line alleviate substantial doubt about the company's ability to continue as a going concern, despite historical operating losses[28](index=28&type=chunk)[29](index=29&type=chunk) - All revenue for the three months ended April 30, 2025 and 2024, was generated from the sale of goods within the United States[39](index=39&type=chunk) - The company is a defendant in a lawsuit with Joseph Gunnar, LLC, and Lucosky Brookman LLP, who are seeking over **$500,000** in damages, with the company denying allegations and filing counterclaims; a **$100,000** settlement offer from plaintiffs has not been responded to[99](index=99&type=chunk)[100](index=100&type=chunk)[101](index=101&type=chunk) - The company signed an amended agreement with Kindeva Drug Delivery for Aversa Fentanyl, reducing labor rates in exchange for a **$3.0 million** milestone payment upon FDA approval[96](index=96&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=27&type=section&id=Item%202%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management attributes Q1 2025 revenue growth to increased demand, with a narrowed net loss due to reduced expenses, and believes recent financing alleviates going concern doubts Results of Operations Comparison (in USD) | Metric | Three Months Ended April 30, 2025 | Three Months Ended April 30, 2024 | | :--- | :--- | :--- | | Revenue | $667,432 | $408,532 | | Gross Profit | $251,981 | $164,786 | | R&D Expenses | $683,426 | $974,535 | | SG&A Expenses | $982,052 | $1,079,728 | | Net Loss | $(1,388,869) | $(1,898,077) | - Revenue increase was driven by the Pocono Pharmaceuticals segment due to new equipment meeting increased demand, while the 4P Therapeutics segment generated no revenue[117](index=117&type=chunk) - The decrease in R&D expenses is primarily due to a reduction in labor costs for the Aversa Fentanyl product development[119](index=119&type=chunk) - The company's cash and cash equivalents decreased from **$4.31 million** at Jan 31, 2025, to **$2.96 million** at April 30, 2025, with working capital also decreasing from **$3.81 million** to **$2.50 million**[121](index=121&type=chunk) - In April 2024, the company completed an **$8.4 million** equity financing with European investors to fund operations and development[111](index=111&type=chunk)[116](index=116&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=35&type=section&id=Item%203%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) This section is not applicable for the company at the time of filing - The company has indicated that this item is not applicable[152](index=152&type=chunk) [Controls and Procedures](index=35&type=section&id=Item%204%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were not effective due to material weaknesses, but remediation efforts are underway - The CEO and CFO concluded that disclosure controls and procedures are not effective[154](index=154&type=chunk) - Material weaknesses identified include the absence of segregation of duties and lack of qualified accounting personnel[155](index=155&type=chunk) - Remediation efforts include adding qualified accounting personnel to reduce reliance on third-party consultants and improving internal controls for transaction reviews[155](index=155&type=chunk) [Part II: Other Information](index=36&type=section&id=Part%20II%3A%20Other%20Information) [Legal Proceedings](index=36&type=section&id=Item%201.%20Legal%20Proceedings) The company is a defendant in a lawsuit seeking over $500,000 in damages, denies all allegations, has filed counterclaims, and has not responded to a settlement offer - The company is a defendant in a lawsuit filed by Joseph Gunnar, LLC and Lucosky Brookman LLP in New York[160](index=160&type=chunk) - Allegations include breach of contract, fraudulent activities, and tortious interference, with Gunnar seeking over **$500,000** in damages and LB seeking reimbursement of legal fees[160](index=160&type=chunk) - Nutriband denies all allegations and has filed counterclaims for intentional interference and breach of fiduciary duty, seeking **$1,000,000** for each claim[161](index=161&type=chunk) - The plaintiffs proposed a settlement offer of **$100,000** in early 2024, to which the company has not responded[162](index=162&type=chunk) [Risk Factors](index=36&type=section&id=Item%201A%20Risk%20Factors) The company highlights key risks including economic uncertainty, its pre-market development stage, stock price volatility, potential dilution, and the need to keep pace with technological change - The company faces risks from economic uncertainty and U.S. administration policies that could affect costs and FDA approval timelines[164](index=164&type=chunk) - As a development-stage company with no marketable product in the U.S., there is no assurance of achieving profitability, and the company has a history of substantial losses[165](index=165&type=chunk)[166](index=166&type=chunk) - The company's stock price has been and is expected to remain volatile, and future equity offerings may cause significant dilution to existing stockholders[169](index=169&type=chunk)[170](index=170&type=chunk) - The drug delivery industry is subject to rapid technological change, and a failure to keep pace could render the company's products obsolete[171](index=171&type=chunk) [Exhibits](index=38&type=section&id=Item%206%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including CEO and CFO certifications and Inline XBRL data files Filed Exhibits | Exhibit Number | Description | | :--- | :--- | | 31.1 | Section 302 Certification of Chief Executive Officer | | 31.2 | Section 302 Certification of Chief Financial Officer | | 32.1 | Section 906 Certification of Chief Executive Officer | | 32.2 | Section 906 Certification of Chief Financial Officer | | 101 | Inline XBRL Documents (Instance, Schema, Calculation, etc.) |

Core Insights - Nutriband Inc. has made significant progress in the commercialization of its AVERSA technology, aimed at improving the safety of transdermal drugs prone to abuse, particularly pain medications [4][6][10] Company Achievements - The company has established a partnership with Kindeva Drug Delivery to develop AVERSA Fentanyl, which is expected to be the first opioid pain patch with abuse deterrent properties [5][8] - Nutriband has expanded its intellectual property portfolio, securing patents in 46 countries, including recent approvals in China, Hong Kong, and the United States [9][15] - The company raised $8.4 million in April 2024 through a non-brokered private placement, primarily from existing shareholders, to support its development efforts [8] Financial Outlook - AVERSA Fentanyl is projected to achieve peak annual sales between $80 million and $200 million, while AVERSA Buprenorphine is estimated to reach peak sales of $70 million to $130 million [6] - The Pocono Pharma subsidiary is expected to have a strong revenue year in 2025 due to expanding collaborations in contract manufacturing services [11] Future Goals - Nutriband aims to initiate a pivotal Human Abuse Liability clinical trial for AVERSA Fentanyl in 2025, supporting an NDA filing with the FDA [10] - The company plans to explore international partnerships for its AVERSA intellectual property as it approaches the NDA filing [10]

Financial Performance - For the year ending January 31, 2025, the company generated revenue of $2,139,537, a 2.6% increase from $2,085,314 in the previous year[165]. - The company's gross margin for the year ending January 31, 2025, was $743,317, down from $862,105 in the prior year, primarily due to lower margins on tape sales[165]. - The company incurred a net loss of $10,482,617, or $(0.99) per share, for the year ended January 31, 2025, compared to a loss of $5,485,314, or $(0.69) per share, for the previous year[171]. - Selling, general and administrative expenses increased to $4,313,810 for the year ending January 31, 2025, from $3,773,606 in the previous year, primarily due to higher non-cash compensation and public relations costs[166]. - The company has not generated any revenue from its 4P Therapeutics segment for the year ending January 31, 2025, due to a shift in focus and the winding down of the main contract[165]. - The company anticipates an increase in demand for its products in the subsequent year, despite the decline in gross margin[165]. Research and Development - Research and development expenses for the Aversa Fentanyl product amounted to $3,119,134 for the year ending January 31, 2025, compared to $1,960,425 in the previous year, reflecting increased labor and material costs[167]. - Research and development costs are expensed as incurred, indicating a focus on innovation and product development[201]. Cash and Working Capital - As of January 31, 2025, the company had cash and cash equivalents of $4,311,719 and working capital of $3,811,420, significantly up from $492,942 and $22,770, respectively, as of January 31, 2024[172]. - As of January 31, 2025, the Company had cash and cash equivalents totaling $3,804,000, exceeding federally insured cash balance limits[189]. Impairment and Goodwill - An impairment charge of $3,595,216 was recorded during the year ending January 31, 2025, reducing the value of goodwill and intangible assets[168]. - Goodwill amounted to $1,719,535 as of January 31, 2025, down from $5,021,713 as of January 31, 2024, following an impairment charge of $3,302,478 during the year[194]. - The Company recorded an impairment charge of $293,038 to its intellectual property during the year ending January 31, 2025[193]. Inventory and Accounts Receivable - As of January 31, 2025, the total inventory was $212,041, consisting of work-in-process of $46,255, finished goods of $16,609, and raw materials of $149,177, compared to $168,605 in total inventory as of January 31, 2024[191]. - The Company recorded bad debt expenses of $1,200 and $11,836 for doubtful accounts related to accounts receivable for the years ended January 31, 2025, and 2024, respectively[190]. - The Company maintains allowances for doubtful accounts based on specific identification and historical loss application, reflecting a proactive approach to credit risk management[190]. Accounting Policies - The Company completed necessary changes to its accounting policies and internal controls to comply with lease accounting standards[200]. - The Company recognizes deferred tax assets and liabilities based on the differences between financial statements and tax basis, using enacted tax rates[203]. - The Company applies a straight-line depreciation method for property, plant, and equipment, with useful lives ranging from 3 to 20 years[192].

Core Insights - Nutriband Inc. has received a patent grant in Macao for its AVERSA™ abuse deterrent transdermal technology, enhancing its intellectual property portfolio [1][2][3] - The AVERSA™ technology aims to prevent the abuse and misuse of drugs, particularly opioids, while ensuring accessibility for patients in need [4][6] - The company is collaborating with Kindeva Drug Delivery to develop AVERSA™ Fentanyl, which could potentially achieve peak annual US sales between $80 million and $200 million [5][6] Intellectual Property - The patent J/9010 was granted on February 11, 2025, and is part of a broader international portfolio covering 46 countries, including major markets like the US, Europe, and China [2][3] - Macao's patent system operates independently from mainland China's, providing a unique advantage for Nutriband's technology [2] Product Development - AVERSA™ technology incorporates aversive agents into transdermal patches to mitigate risks associated with drug abuse, including accidental exposure [4][6] - The lead product under development is an abuse-deterrent fentanyl patch, which is designed to be the first of its kind in the market [5][6] Market Potential - The AVERSA™ Fentanyl patch is positioned to address significant market needs in opioid management, with a substantial projected sales range indicating strong market interest [6]

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 technology, which is positioned as a potential breakthrough in abuse deterrent patches for chronic pain management [3][4] Company Overview - Nutriband Inc. focuses on developing transdermal pharmaceutical products, with its lead product being an abuse deterrent fentanyl patch utilizing AVERSA technology [4] - 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 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].