Core Viewpoint - Nutriband Inc. has received a new patent for its AVERSA™ transdermal abuse deterrent technology, enhancing its intellectual property protection in the United States and internationally, which is crucial for the development of its lead product, an abuse-deterrent fentanyl patch [1][2][3]. Group 1: Patent and Technology - The United States Patent and Trademark Office issued patent number 12,318,492 for "Abuse and Misuse Deterrent Transdermal Systems" on June 3, 2025, expanding Nutriband's intellectual property protection [1]. - AVERSA™ technology incorporates aversive agents into transdermal patches to prevent abuse, misuse, and accidental exposure of drugs with abuse potential, improving the safety profile of transdermal drugs like fentanyl [3][4]. Group 2: Market Potential - Nutriband's lead product under development, Aversa™ Fentanyl, is projected to achieve peak annual U.S. sales between $80 million and $200 million, positioning it as a potential market leader in abuse-deterrent pain patches [2].

ORLANDO, Fla., June 03, 2025 (GLOBE NEWSWIRE) -- Nutriband Inc. (NASDAQ:NTRB) (NASDAQ:NTRBW) today announced that CEO, Gareth Sheridan will present at Noble Capital Markets’ Emerging Growth Virtual Equity Conference on Thursday, June 5th at 4PM Eastern Standard Time. The formal presentation will feature a fireside style Q&A session with questions welcome from the live virtual audience. Scheduled 1x1 meetings with the Company are also available for registered, qualified investor attendees. Attendees interest ...

Core Insights - Nutriband Inc. reported a record revenue of $667,000 for Q1 2025, reflecting a 63% year-over-year increase [2] - The company is expanding its kinesiology tape production through its Pocono Pharma subsidiary, focusing on penetration pricing to establish partnerships with major retail brands [2] - Nutriband is advancing the development of AVERSA Fentanyl through a partnership with Kindeva Drug Delivery, aimed at regulatory approval and commercialization [3] Financial Performance - The first quarter revenue of $667,000 represents a significant growth of 63% compared to the same period last year [2] - The increasing revenue from Pocono is crucial for enhancing shareholder value [2] Product Development - AVERSA Fentanyl is being developed as the world's first abuse-deterrent opioid patch, which aims to reduce the risk of misuse and accidental exposure [4] - The potential peak annual sales for AVERSA Fentanyl in the U.S. are estimated to be between $80 million and $200 million [4] - The partnership with Kindeva Drug Delivery involves shared development costs and milestone payments, facilitating the advancement of Nutriband's transdermal drug delivery solutions [3]

[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]