Core Viewpoint - Nutriband Inc. CEO Gareth Sheridan will temporarily step aside to participate in the Irish Presidential Election, with Chairman Serguei Melnik taking over as interim CEO during this period [1][2][3] Company Leadership Transition - Gareth Sheridan will step down for three months, with the nomination hearings and election occurring in September and October [1] - Serguei Melnik, co-founder and Chairman, will assume CEO responsibilities and guide the company towards its NDA filing target in 2026 [2] Strategic Focus - Melnik, with over 20 years of experience in capital markets, will continue to execute the company's strategic development and focus on enhancing shareholder value [2] - Sheridan emphasized the strength of the company's team as its core asset and expressed confidence in meeting planned targets during his absence [3] Product Development - Nutriband's lead product, AVERSA Fentanyl, has received FDA approval for a meeting request, positioning it as a potential first-of-its-kind abuse-deterrent opioid patch [4] - AVERSA Fentanyl is projected to achieve peak annual US sales between $80 million and $200 million, with plans to expand into major global markets [4] Intellectual Property - The AVERSA technology is protected by a broad international intellectual property portfolio, with patents issued in 46 countries, including the US, Europe, and China [5] Company Overview - Nutriband Inc. focuses on developing transdermal pharmaceutical products, with AVERSA technology designed to prevent the abuse and accidental exposure of drugs with abuse potential [6]

Core Viewpoint - The FDA has granted Nutriband a Type C Meeting to discuss the Chemistry, Manufacturing, and Controls plans for its AVERSA™ FENTANYL product, which aims to provide an abuse-deterrent transdermal system for fentanyl [1][2]. Group 1: Product Development - Nutriband is collaborating with Kindeva to develop AVERSA™ FENTANYL, integrating Nutriband's abuse-deterrent technology with Kindeva's FDA-approved fentanyl patch [1][2]. - The AVERSA™ technology incorporates aversive agents into transdermal patches to prevent abuse, misuse, and accidental exposure of drugs with abuse potential, particularly opioids [3][6]. Group 2: Market Potential - AVERSA FENTANYL could be the first abuse-deterrent opioid patch, with potential peak annual sales in the U.S. estimated between $80 million and $200 million [4]. - The company aims to address the global unmet medical need for effective pain management by making AVERSA FENTANYL available in major medical markets worldwide [4]. Group 3: Intellectual Property - The AVERSA™ abuse-deterrent technology is protected by a broad international intellectual property portfolio, with patents issued in 46 countries, including the U.S., Europe, Japan, and China [5][6]. Group 4: Company Overview - Nutriband is focused on developing a portfolio of transdermal pharmaceutical products, with its lead product being the abuse-deterrent fentanyl patch [7].

Company Overview - Nutriband Inc. is focused on developing transdermal pharmaceutical products, with its lead product being an abuse-deterrent fentanyl patch utilizing AVERSA™ technology [4] - The AVERSA™ technology aims to prevent the abuse, misuse, diversion, and accidental exposure of drugs with abuse potential, particularly fentanyl [3][4] Preferred Stock Dividend - Nutriband is issuing a 25% preferred stock dividend, where shareholders of record on July 25, 2025, will receive one preferred share for every four common shares held [1] - The pay date for the new issuance is set for August 5, 2025 [1] Conversion and Dividend Details - Each preferred share will be convertible into one share of common stock upon FDA approval of the AVERSA Fentanyl product [2] - If not converted, preferred shares will receive an annual cash dividend from the company's profits, as determined by the Board of Directors [2]

Core Points - Nutriband Inc. has declared a 25% preferred stock dividend, with shareholders of record on July 25, 2025, receiving one preferred share for every four common shares held, payable on August 5, 2025 [1] - Each preferred share will be convertible to one common share following FDA approval of the AVERSA Fentanyl product, and if unconverted, will receive annual cash dividends from company profits as determined by the Board of Directors [2] - The CEO emphasized the company's focus on creating shareholder value and advancing the commercialization of the AVERSA Fentanyl product, highlighting recent progress in manufacturing scale-up with Kindeva [3] Product Information - AVERSA™ technology is designed to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential, particularly fentanyl, while ensuring accessibility for patients in need [4] - Nutriband is primarily focused on developing transdermal pharmaceutical products, with the AVERSA™ abuse-deterrent fentanyl patch as its lead product [5] Company Overview - Nutriband Inc. is engaged in the development of a portfolio of transdermal pharmaceutical products, with a strong emphasis on abuse-deterrent technologies [5]

Company Overview - Nutriband Inc. has been added to multiple Russell indexes, including the Russell Microcap, Russell Microcap Growth, Russell 3000E, and Russell 3000E Growth Indexes as part of the 2025 reconstitution [1][2] - The company focuses on developing transdermal pharmaceutical products, with its lead product being an abuse-deterrent fentanyl patch utilizing AVERSA™ technology [6] Product and Technology - AVERSA™ technology incorporates aversive agents into transdermal patches to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential, particularly fentanyl [5] - The potential peak annual US sales for AVERSA Fentanyl are estimated to be between $80 million and $200 million [2] Market Context - Russell indexes are widely utilized by investment managers and institutional investors, serving as benchmarks for approximately $10.6 trillion in assets as of June 2024 [3] - FTSE Russell, the global index provider, emphasizes the importance of adapting indexes to reflect the evolving US economy, with a transition to semi-annual reconstitution planned for 2026 [4]

Core Viewpoint - Nutriband has successfully completed the commercial manufacturing process scale-up for its lead product, Aversa™ Fentanyl, in partnership with Kindeva, marking a significant milestone towards developing a commercially viable abuse-deterrent fentanyl patch [1][3]. Group 1: Product Development - Aversa™ Fentanyl combines Nutriband's abuse-deterrent technology with Kindeva's FDA-approved fentanyl patch, and is manufactured at Kindeva's advanced transdermal facility in the United States [2]. - The next steps include manufacturing clinical supplies and filing an Investigational New Drug (IND) application with the FDA to initiate a human abuse liability clinical study [2]. Group 2: Market Potential - Aversa Fentanyl has the potential to be the first abuse-deterrent opioid patch on the market, aimed at deterring abuse and reducing accidental exposure risks, with projected peak annual US sales between $80 million to $200 million [5]. - The company plans to initially focus on the US market while also targeting global markets due to the widespread unmet medical need for effective pain management [5]. Group 3: Technology and Intellectual Property - Nutriband's AVERSA™ abuse-deterrent technology incorporates aversive agents into transdermal patches to prevent drug abuse, ensuring that these medications remain accessible to patients in need [4][7]. - The technology is protected by a broad international intellectual property portfolio, with patents issued in 46 countries, including major markets such as the United States, Europe, and China [6][7].

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].

Company Overview - Nutriband Inc. is primarily engaged in the development of transdermal pharmaceutical products, with its lead product being an abuse-deterrent fentanyl patch that incorporates AVERSA™ technology [3] Upcoming Event - CEO Gareth Sheridan will present at Noble Capital Markets' Emerging Growth Virtual Equity Conference on June 5 at 4 PM Eastern Standard Time, featuring a fireside style Q&A session [1] - Attendees can register for the event at no cost, and a video webcast will be available on the company's website and Channelchek for 90 days post-event [2] About Noble Capital Markets - Noble Capital Markets is a full-service investment bank and advisory firm established in 1984, known for its award-winning research team and investor distribution platform [5] About Channelchek - Channelchek, launched in 2018, is an investor community dedicated to public emerging growth companies, offering free institutional-quality research and listing over 7,000 public companies [6]

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.) |