Annonce • May 16
Active Intelligence and Nutriband Inc. Showcases Expanding Ai Wellness Product Portfolio and Announces New June Product Launches At Ecrm Conference Nutriband Inc. and its wholly owned subsidiary Active Intelligence announced its participation in the upcoming ECRM conference taking place in June 2026, where the Company will showcase its latest AI-branded product portfolio to buyers and executives from some of the nation’s largest retail and healthcare organizations. During the conference, Active Intelligence is scheduled to meet with category buyers and decision-makers representing major national retailers and distributors, including Walmart, Walgreens, Amazon, Cardinal Health, and numerous additional retail, pharmacy, healthcare, and e-commerce channels. The Company will feature its growing AI Tape product line, which continues to gain traction within the wellness, recovery, and athletic performance categories. In addition, Active Intelligence plans to introduce several new products scheduled for launch in June 2026, including: AI Performance Tape—a next-generation kinesiology and recovery product designed to support athletic performance, mobility, muscle recovery, and active lifestyles; AI Energy Patches—innovative wearable wellness patches formulated to support energy, focus, and daily performance; and AI Sleep—a wellness-focused solution developed to support relaxation, recovery, and improved sleep quality. The Company believes these new additions further strengthen its position within the rapidly expanding global wellness market and broaden its opportunities for national retail placement across multiple high-growth consumer categories. Annonce • Mar 18
Nutriband Ai Kinesiology Tapes Approves for Distribution and Sale in Costa Rica Nutriband Inc. announced that The Costa Rica Ministry of Health has approved the Company’s line of Kinesiology Tapes for import and Sale. Innomedica CCB, the company’s exclusive distribution partner for Costa Rica oversaw and financed the regulatory approval process. The Company, partnering with Innomedica plans to begin ramping up marketing efforts for these products and its mosquito repellant patch line following this latest approval. Annonce • Feb 04
Nutriband Inc. Announces Election of New Directors Nutriband Inc. announced that Following the completion of the shareholder meeting, the Board of Directors, at its Annual Meeting, elected the following two new directors to the Company’s Board of Directors, to serve and hold office until the next annual meeting of stockholders, or until their earlier resignacingn or removal from office. Alessandro Puddu, age 42, is an Italian Chartered Accountant and Statutory Auditor with a practice of audit, corporate advisory and financial reporting for industrial groups and listed companies. He advises companies on tax and corporate matters, company valuations, extraordinary corporate transactions and IAS/IFRS reporting, including consolidated financial statements. At the beginning of his career, he worked at PricewaterhouseCoopers as a Senior Auditor, reviewing Italian and multinational companies operating in various industrial sectors and is.enrolled in the Italian Register of Chartered Accountants (Dottori Commercialisti), the Register of Statutory Auditors held by the Italian Ministry of Economy and Finance, and the Register of Crisis & Insolvency Practitioners, and he has a Master’s Degree in Economics and Management. Viorica Carlig, age 50, has been the manager of TII Jet Services LDA, an aircraft service company, and has professional management experience for a substantial period in the management and growth of companies in the aircraft industry and as well in the industry’s regulatory compliance requirements. She received Ph.D. in Economics in 1999, and a Masters Degree in Business Administration from the Bucharest Academy of Economic Studies in 2006 and 1999, respectively. She further received Bachelor Degrees in Law and Commerce from the University of Bucharest and the Bucharest Academy of Economic Studies, in 2002 and 1998, respectively. Annonce • Dec 30
EarthVision Bio Solutions Inc. signed an agreement to acquire 90% stake in Pocono Pharmaceuticals, Inc. from Nutriband Inc. (NasdaqCM:NTRB) for $5 million. EarthVision Bio Solutions Inc. signed an agreement to acquire 90% stake in Pocono Pharmaceuticals, Inc. from Nutriband Inc. (NasdaqCM:NTRB) for $5 million on December 29, 2025. Nutriband Inc. Shareholders will retain 10% of the shareholding in Earth Vision Bio following the acquisition.
The expected completion of the transaction is December 31, 2025. Nutriband inc. will use the proceeds from the sale of Pocono Pharma towards its continued development of AVERSA Fentanyl. Annonce • Dec 22
Nutriband Inc., Annual General Meeting, Jan 24, 2026 Nutriband Inc., Annual General Meeting, Jan 24, 2026. Location: 400 west church street, city national hourglass room, fl 32801, orlando, United States Annonce • Oct 28
Nutriband Announces Successful Meeting Completed with United States Fda for Its Abuse Deterrent Fentanyl Patch Nutriband Inc. announced that it has received final meeting minutes from its recent virtual face-to-face meeting held on September 18, 2025 with the United States Food and Drug Administration (US FDA) for its lead product, AVERSA™? FENTANYL (abuse deterrent fentanyl transdermal system). The meeting was held as a videoconference with the Division of Anesthesiology, Addiction Medicine, and Pain Medicine (DAAP) in the Office of Neuroscience (ON), Center for Drug Evaluation and Research (CDER). The proposed indication is management of pain in opioid-tolerant patients, severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternate treatment options are inadequate. The purpose of the meeting was to specifically provide feedback on the Chemistry, Manufacturing, and Controls (CMC) plans for the product from submission of an Investigational New Drug Application (IND) through approval of a 505(b)(2) New Drug Application (NDA). The main outcomes of the meeting were: The FDA confirmed that the regulatory pathway for the product is a 505(b)(2), NDA and provided guidance on the relied upon reference listed drug and bridging strategy. FDA provided expectations and constructive feedback on the registration batch plan and manufacturing process validation strategy for NDA submission. FDA discussed various considerations and advice for the finalization of the product specifications and stability testing plans for the clinical and commercial products. FDA provided feedback on the planned laboratory-based in vitro manipulation and extraction studies (Category1) to be conducted to fully characterize the product's abuse-deterrent properties, including the degree of effort required by an abuse to bypass or defeat those properties. In the past, the FDA has put out several warnings on the risks of fentanyl patchaccidental exposure, particularly in children, but to date there have not been any abuse deterrent fentanylpatches approved in the U.S, or in any other country to knowledge. Nutriband is partnering with Kindeva to develop AVERSA™? FentANYL which combines Nutriband's AVERSA™? abuse-deterrent technology with Kindeva's FDA-approved fentanyl patch. FDA Consumer Update: Accidental Exposures to Fentanyl Patches Continue to Be deadly to Children. FDA Drug Safety Communication: FDA requiring color changes to Duragesic (fentanyl) pain patches to aid safety--em emphasizing that accidental exposure to used patches can cause death (2013). With best-in-class facilities and comprehensive CDMO services, offer more than manufacturing--we deliver strategic value. The Company's actual results may differ materially from those anticipated in its forward-looking statements as a result of a num ber of factors, including those including the Company's ability to develop its proposed abuse-deterrent fentanyl transdermal system and other proposed products, its ability to obtain patent protection for its abuse technology, its ability to obtain the necessary financing to develop products and conduct the necessary clinical testing, its ability to obtain Federal Food and Drug Administration approval to market any product it may develop in the United States and to obtain any other regulatory approval necessary to market any product in other countries, including countries in Europe, its ability to market any product it may developed, its ability to create, sustain, manage or forecast its growth; its ability to attract and retain key personnel; changes in the Company's business strategy or development plans; competition; business disruptions; adverse publicity; and adverse publicity; and the Company's plans. Annonce • Oct 27
Nutriband Announces CEO Changes Nutriband Inc. announced that Company founder, Gareth Sheridan has returned as Company CEO. During the period of August 10 until October 27, Co-Founder and Chairman, Serguei Melnik had taken over the responsibilities of CEO. Mr. Sheridan has returned to the position of CEO effective immediately and will guide the company through the final 2025 framework towards the target NDA filing in 2026 for AVERSA Fentanyl. Annonce • Oct 08
Nutriband Files Provisional Patent Application for Enhanced Transdermal Abuse Deterrent Technology Nutriband Inc. announced that it has filed a provisional patent application with the U.S. Patent and Trademark Office (USPTO) to further strengthen Nutriband's intellectual property protection for its AVERSA™? abuse deterrent transdermal technology. The provisional patent application covers improved aversive formulations and coating application methods to enhance the abuse deterrent properties of Nutriband's AVERSA™? transdermal technology and make it even more difficult to defeat. If this provisional patent application is converted into a non-provisional patent application and a new patent is subsequently granted, it could significantly extend the patent protection for products that utilize Nutriband's AverSA™? abuse deterrent technology as the statutory patent term of a US patent is 20 years from the non-provisional filing date. The AVERSA™? abuse deterrent technology is protected by a broad international intellectual property portfolio with patents issued in 46 countries including the United States, Europe, Japan, Korea, Russia, China, Canada, Mexico, and Australia. Nutriband's AVER SA™? abuse-deterrent technology can be utilized to incorporate aversive agents into transdermal patches to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential including opioids and stimulants. The AVERSA™®? abuse-deterrent Technology has the potential to improve the safety profile of transdermal drugs susceptible to abuse, such as opioids, while making sure that these drugs remain accessible to those patients who really need them. Annonce • Aug 12
Nutriband Inc. Announces CEO Changes Nutriband Inc. has announced that Company CEO, Gareth Sheridan will be stepping aside from his role for three months to enter the Irish Presidential election. The Nomination Hearings followed by the Election will take place over the course of September and October. During this period, Co-Founder and Chairman, Serguei Melnik will take over the responsibilities of CEO and guide the company through the final 2025 framework towards the target NDA filing in 2026. Mr. Melnik, a corporate strategy expert will continue to execute the Company’s strategic development and focus on shareholder value. Mr. Melnik has over 20 years experience in Capital markets. Annonce • Aug 08
Fda Grants Nutriband Meeting Request for Aversa™? Fentanyl Abuse Deterrent Fentanyl Patch Nutriband Inc. announced that the United States Food and Drug Administration (US FDA) has granted a Type C Meeting for its lead product, AVERSA FENTANYL (abuse deterrent transdermal system). The purpose of the meeting is to specifically provide feedback on the Chemistry, Manufacturing, and Controls (CMC) plans for the product from submission of an Investigational New Drug Application (IND) through approval of a 505(b)(2) New Drug Application (NDA) and subsequent commercialization. The meeting is scheduled as a virtual face-to-face meeting to be held on September 18, 2025 with the Division of Anesthesiology, Addiction Medicine, and Pain Medicine (DAAP) in the Office of Neuroscience (ON), Center for Drug Evaluation and Research (CDER). Nutriband is partnering with Kindeva to develop AVERSA™? FENTANYL which combines Nutriband's AVERSA™? abuse-deterrent technology with Kindeva's FDA-approved fentanyl patch. Nutriband's AVER SA™? abuse-deter Brent technology can be utilized to incorporate aversive agents into transdermalpatches to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential including opioids and stimulants. The AVERSA™? Abuse-deterrent technology has the potential to improve the safety profile of transdermal drugs susceptible to abuse, such as fentanyl, while making sure that these drugs remain accessible to those patients who really need them. Any material contained in or derived from the Company's websites or any other website is not part of this press release. Annonce • Jun 18
Nutriband and Kindeva Complete Commercial Manufacturing Process Scale-Up for Aversa™? Fentanyl Abuse Deterrent Fentanyl Patch Nutriband Inc. announced that it has completed commercial manufacturing process scale-up for its lead product, Aversa Fentanyl, with Kindeva, a leading global contract development and manufacturing organization (CDMO) focused on drug-device combination products. Nutriband is partnering with Kindeva to develop Aversa Fentanyl which combines Nutriband's Aversa™? abuse-deterrent technology with Kindeva's FDA-approved fentanyl patch. Aversa Fentanyl is manufactured at Kindeva's transdermal manufacturing facility located in the United States. The next step is to manufacture clinical supplies and file an Investigational New Drug (IND) application with the FDA to initiate a human abuse liability clinical study. Completing the commercial manufacturing scale-up is an important step towards development of a commercially viable product and event NDA filing. This achievement demonstrates the compatibility of the Aversa™? abuse deterrent platform technology with established transdermal patch manufacturing processes. Aversa Fentanyl has the potential to be the first abuse deterrent pain patch on the market. Annonce • Jun 02
Nutriband Inc. Provides Update on the Development of AVERSA Fentanyl Nutriband Inc. reports that the progress continues on the development of AVERSA Fentanyl, with the Company formalizing an exclusive product development partnership with Kindeva Drug Delivery. The formalized partnership with Kindeva Drug Delivery reflects a commitment to shared development costs in exchange for milestone payments, enabling Nutriband to advance its innovative transdermal drug delivery solutions towards regulatory approval and commercialization. AVERSA Fentanyl has the potential to be the world’s first abuse-deterrent opioid patch designed to deter the abuse and misuse and reduce the risk of accidental exposure of transdermal fentanyl patches. AVERSA Fentanyl has the potential to reach peak annual US sales of $80 million to $200 million. Annonce • Feb 11
Nutriband Inc. Appoints Anastasia Nichita to Product Advisory Board Nutriband Inc. announced World and European Wrestling Gold medalist and Olympic Silver medalist Anastasia Nichita has been appointed to its Product Advisory Board to expand the Nutriband Brand and promote it’s over the counter sports and consumer products internationally. Annonce • Dec 27
Nutriband Inc. Extends Chinese Patent to Macao for its AVERSA™ Abuse Deterrent Transdermal Technology Nutriband Inc. announced that it has completed the registration requirements to extend its Chinese patent to Macao for its patent entitled, “Abuse and Misuse Deterrent Transdermal Systems,” which protects its AVERSA™ abuse deterrent transdermal technology. The Macao IP Office has assigned number J/9010 to the patent with an entry date of December 17, 2024. Macao is a Special Administrative Region (SAR) of the People’s Republic of China which affords it a high degree of autonomy with its own patent system and patent laws which are separate and distinct from those of mainland China. The Aversa™ abuse deterrent technology is now covered by a broad international intellectual property portfolio with patents issued in 46 countries including the United States, Europe, Japan, Korea, Russia, China, Canada, Mexico, and Australia as well as two regions of China: Hong Kong and Macao. Nutriband’s 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. The AVERSA™ abuse-deterrent technology has the potential to improve the safety profile of transdermal drugs susceptible to abuse while making sure that these drugs remain accessible to those patients who really need them. Nutriband is currently working with its partner Kindeva Drug Delivery (formerly 3M drug delivery systems), a leading global contract development and manufacturing organization focused on drug-device combination products, to develop its lead product, AVERSA™ Fentanyl, which incorporates Nutriband’s AVERSA™ abuse-deterrent transdermal technology into Kindeva’s FDA-approved transdermal fentanyl patch system. AVERSA Fentanyl has the potential to be the world’s first abuse-deterrent opioid patch designed to deter the abuse and misuse and reduce the risk of accidental exposure of transdermal fentanyl patches. AVERSA Fentanyl has the potential to reach peak annual US sales of $80 million to $200 million. About AVERSA™ Abuse-Deterrent Transdermal Technology: Nutriband's AVERSA™ abuse-deterrent transdermal technology incorporates aversive agents into transdermal patches to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential. The AVERSA™ abuse-deterrent technology has the potential to improve the safety profile of transdermal drugs susceptible to abuse, such as fentanyl, while making sure that these drugs remain accessible to those patients who really need them. The technology is covered by a broad intellectual property portfolio with patents granted in the United States, Europe, Japan, Korea, Russia, China, Canada, Mexico, and Australia. Annonce • Dec 20
Nutriband Inc., Annual General Meeting, Jan 23, 2025 Nutriband Inc., Annual General Meeting, Jan 23, 2025. Location: 400 west church street, city national hourglass room, fl 32801, orlando, United States Annonce • Oct 17
Nutriband Inc.'s Mosquito Repellent Patch Approved by Ministry of Health of Costa Rica Nutriband Inc. announced that it has received approval from the Costa Rica Ministry of Health for the production and marketing of its Mosquito Repellent Patch, designed to reduce the risk of mosquito bites and associated health risks associated with exposure to mosquito bites. The Company intends to further expand distribution throughout South and Central America. The Nutriband insect Repellent Patch contains simple natural ingredients which are used to mask human odors that are attractive to insects. Recommended wear sites include exposed areas of skin such as the neck, arms and leg. The active ingredient in the Nutriband Mosquito Repellent patch is similar to what is used in mosquito patches that were approved in Africa based on extensive safety and efficacy testing with a goal to reduce the spread of malaria and HIV. Specific country approvals in Africa included Ghana, Nigeria and the Ivory Coast. Nutriband Inc.'s wholly owned contract manufacturing subsidiary, Pocono Pharmaceutical will act as exclusive manufacturer for the product. Annonce • Sep 24
Nutriband Receives China Patent Notice of Allowance for Its Aversa(TM) Abuse Deterrent Transdermal Technology Nutriband Inc. announced that it has received a Notice of Allowance from the Chinese National Intellectual Property Administration (CNIPA) for patent application entitled, "Abuse and Misuse Deterrent Transdermal Systems," which protects its AVERSA™ abuse deterrent transdermal technology. The Aversa™ abuse deterrent technology is now covered by a broad international intellectual property portfolio with patents issued in 46 countries including the United States, Europe, Japan, Korea, Russia, Mexico, Canada, Australia, and China. Nutriband's 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. The AVERSA™ abuse-deterrent technology has the potential to improve the safety profile of transdermal drugs susceptible to abuse while making sure that these drugs remain accessible to those patients who really need them. Nutriband abuse-deterrent transdermal technology consists of a proprietary aversive agent coating that employs taste aversion to deter the oral abuse of and accidental exposure to transdermal opioid and stimulant patch products. Preliminary studies have shown that the coating is very difficult to scrape off and the technology has a patented immediate and extended-release profile which presents an additional layer of deterrence to prevent the aversive layer from easily being washed off in an attempt to separate the drug from the aversive agents. Nutriband is currently working with its partner Kindeva Drug Delivery, a leading global contract development and manufacturing organization focused on drug-device combination products, to develop its lead product, AVERSA™ Fentanyl, which incorporates Nutriband's AVERSA™ abuse-deterrent transdermal technology into Kindeva's FDA-approved transdermal fentanyl patch system. AVERSA Fentanyl has the potential to be the world's first abuse-deterrent opioid patch designed to deter the abuse and misuse and reduce the risk of accidental exposure of transdermal fentanyl patches. AVERSA Fentanyl has the potential to reach annual US sales of $80 million to $200 million. Annonce • Sep 19
Nutriband Inc. (NasdaqCM:NTRB) announces an Equity Buyback for $1 million worth of its shares. Nutriband Inc. (NasdaqCM:NTRB) announces a share repurchase program. Under the program, the company will repurchase up to $1 million worth of its common stock. As of September 16, 2024, the company had 11,106,185 shares of common stock outstanding. Reported Earnings • Sep 05
Second quarter 2025 earnings released: US$0.15 loss per share (vs US$0.11 loss in 2Q 2024) Second quarter 2025 results: US$0.15 loss per share (further deteriorated from US$0.11 loss in 2Q 2024). Revenue: US$442.8k (down 33% from 2Q 2024). Net loss: US$1.71m (loss widened 106% from 2Q 2024). Annonce • Jun 21
Nutriband Inc. Provides Product Development Update for its Lead Product Aversa Fentanyl Nutriband Inc. provided an update on its Aversa Fentanyl product development program to shareholders as it aims to complete scale-up of the commercial manufacturing process and move towards the single Phase 1 human abuse potential study prior to NDA filing. As previously reported, the Company with its partner Kindeva Drug Delivery completed the feasibility agreement and entered into a commercial development and clinical supply agreement to manufacture product for the human abuse potential clinical study in support of a New Drug Application (NDA) to be submitted to FDA. The feasibility agreement was focused on adapting Kindeva's commercial transdermal manufacturing process to incorporate AVERSA™ abuse deterrent transdermal technology. Nutriband is currently working with its partner Kindeva Drug Delivery to develop the commercial scale manufacturing process for the final product which will incorporate Nutriband's AVERSA abuse-deterrent transdermal technology into Kindeva's FDA-approved transdermal fentanyl patch system. Recently, Kindeva Drug Delivery completed the validation of the aversive agent cleaning analytical methods required to allow work with the aversive agents, denatonium benzoate and capsaicin, on the commercial manufacturing line. Once the final commercial product manufacturing process is completed, Nutriband intends to file an IND with the FDA and perform the pivotal laboratory and clinical evaluations to demonstrate the abuse-deterrent properties of AVERSA Fentanyl, in compliance with FDA Guidance. Nutriband will file an Investigational New Drug (IND) application with the FDA prior to conducting the single Phase 1 human abuse potential clinical study required for its NDA. The IND will include the chemistry, manufacturing, and controls (CMC) information for the commercial product as well as the clinical study protocol for the human abuse potential study. No Phase 2 or phase 3 Clinical Trials are required prior to submitting for approval. AVERSA(TM) Fentanyl is estimated to have the potential to reach peak annual US sales of $80 million to $200 million, according to a market analysis report from Health Advances. The pivotal laboratory assessment to be conducted is a series of in vitro manipulation and extraction studies designed to determine if the potentially abuse-deterrent properties of the product can be defeated or compromised based on physical and chemical manipulation of the product. Preliminary studies conducted to date have shown that the AVERSA technology is very difficult to defeat by various physical or chemical means. The pivotal clinical study is a human abuse potential study performed to assess the impact of the potentially abuse-deterrent properties in a drug-experienced, recreational user population. The human abuse potential study is a randomized, double-blind, placebo-controlled and positive controlled crossover study comparing AVERSA Fentanyl to the currently marketed fentanyl patch which does not contain abuse-deterrent technology. The success of the human abuse potential study is based on the assessment drug liking using various instruments that are predictive of the likelihood of abuse. Nutriband's AVERSA abuse-deterrent technology incorporates aversive agents into transdermal patches to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential. The AVERSA abuse-deterrent technology has the potential to improve the safety profile of transdermal drugs susceptible to abuse, such as fentanyl while making sure that these drugs remain accessible to those patients who really need them. The technology is covered by a broad intellectual property portfolio with patents granted in the United States, Europe, Japan, Korea, Russia, Canada, Mexico, and Australia. Annonce • May 19
Nutriband Inc. Appoints Sergei Glinka to Its Board of Directors Nutriband Inc. announced the appointment of Sergei Glinka to its board of directors. Glinka is a seasoned and highly respected business executive with an impressive track record in leadership roles across major European companies. Mr. Glinka, an Estonian citizen, is an experienced and highly regarded businessman who has held numerous Executive and Board positions in large European Companies providing Glinka with deep insights and networks across various industries in Europe. Currently Mr. Glinka serves on the Boards of European Companies including Automecanica Skb Property Srl., GST Investments OU and TG Biochemicals Ltd. As the seventh member of Nutriband's board of directors, Glinka is poised to facilitate new licensing and networking opportunities throughout Europe as Nutriband aims to expand its AVERSA technology internationally. Currently, AVERSA is patented in 45 countries, including all EU countries and the UK. Annonce • May 03
Nutriband Inc. announced delayed annual 10-K filing On 05/01/2024, Nutriband Inc. announced that they will be unable to file their next 10-K by the deadline required by the SEC. Reported Earnings • May 02
Full year 2024 earnings released: US$0.69 loss per share (vs US$0.53 loss in FY 2023) Full year 2024 results: US$0.69 loss per share (further deteriorated from US$0.53 loss in FY 2023). Revenue: US$2.09m (flat on FY 2023). Net loss: US$5.49m (loss widened 22% from FY 2023). Annonce • Apr 25
Nutriband Inc. announced that it expects to receive $8.4 million in funding Nutriband Inc. announced that it has entered into definitive securities purchase agreements for the purchase and sale of an aggregate of 2,100,000 shares of common stock at a price of $4 per share for the aggregate gross proceeds of $8,400,000 on April 23, 2024. Annonce • Mar 30
Nutriband Inc. Provides Clinical and Regulatory Path Overview for Lead Product - AVERSA(R) Fentanyl Transdermal Patch Nutriband Inc. provided an overview of the clinical development and regulatory pathway for its lead product, AVERSA Fentanyl, an abuse-deterrent fentanyl transdermal patch. Nutriband has partnered with Kindeva Drug Delivery, a leading global contract development and manufacturing organization, to incorporate Nutriband's AVERSA abuse-deterrent transdermal technology into Kindeva's FDA-approved transdermal fentanyl patch system. As Nutriband's abuse-deterrent technology is incorporated into the fentanyl patch but is physically separate and does not come in contact with the drug layer, the clinical trials typically needed to demonstrate safety and efficacy for a new drug formulation are not required. Nutriband plans to utilize the 505(b)(2) New Drug Application (NDA) regulatory pathway which limits the development required for products that contain drugs that have already been approved, and allows applicants to reference data already on file at the FDA. As a result, the NDA application will be primarily based on a single Phase 1 human abuse potential clinical study with no Phase 2 or 3 clinical trials needed. A clinical abuse potential study is typically performed in recreational drug abuse and is designed to demonstrate that the abuse-deterrent product is less preferable to recreational drug abuse than conventional fentanyl patches which contain no abuse-deterrent technology. Following a successful Phase 1 clinical abuse potential study, Nutriband intends to file a 505(b)(2) NDA to the FDA for marketing approval of AVERSA Fentanyl, which has the potential to be the first and only abuse deterrent patch approved anywhere in the world. The AVERSA Fentanyl NDA has the potential to receive an expedited review by FDA as has been granted for certain abuse-deterrent oral opioid products, which shortens the regulatory review period to six months from the conventional 10-month FDA review cycle for NDAs. Combined, the clinical development and regulatory path for AVERSA Fentanyl is substantially limited compared to conventional pharmaceutical product development, requiring only a single clinical trial and, following a limited NDA pathway, undergoing an expedited review by the FDA. Nutriband is developing its proprietary AVERSA abuse deterrent transdermal technology to be incorporated into any transdermal patch that contains a drug with a risk of abuse, misuse, or accidental exposure. The Company's AVERSA product development pipeline includes abuse deterrent versions of currently approved and marketed transdermal patches containing fentanyl, buprenorphine and methylphenidate which are labeled with FDA-required warnings for the risk of abuse and misuse, as well as warnings against accidental exposure. Annonce • Mar 26
Nutriband Inc. Announces Data Supporting Need for Safer Abuse-Deterrent Transdermal Patches Presented At 2024 American Academy of Pain Medicine Annual Meeting Nutriband Inc. announced that data on the incidence of transdermal patch abuse and accidental pediatric exposure was presented at the 2024 American Academy of Pain Medicine (AAPM) Annual Meeting on March 8, 2024. The American Academy of Pain Medicine (AAPM) is dedicated to advancing multidisciplinary pain care, education, advocacy, and research. The data indicate that transdermal patch abuse and accidental pediatric exposures to patches continue to be a serious problem resulting in major medical outcomes and death, suggesting an unmet need for safer abuse-deterrent versions of transdermal patches containing drugs with a risk of abuse, misuse or accidental exposure. Nutriband's lead product is AVERSA™ Fentanyl which combines Nutriband's proprietary AVERSA™ abuse-deterrent transdermal technology with an already FDA-approved transdermal fentanyl patch and has the potential to become the world's first opioid patch with abuse-deterrent properties. AVERSA™ Fentanyl is estimated to have the potential to reach peak annual US sales of $80 million - $200 million. Nutriband is developing its proprietary Aversa® abuse-deterrent transdermal technology which can be incorporated into any transdermal patch that contains any drug with a risk of abuse, misuse or accidental exposure. Its Aversa® product development pipeline includes abuse-deterrent versions of currently approved and marketed transdermal patches containing fentanyl, buprenorphine and methylphenidate which are labeled with FDA-required warnings for the risk of abuse and misuse, as well as warnings against accidental exposure. Transdermal patches are designed to provide an alternative route of administration for opioid or stimulant drugs that are prescribed for treatment of conditions such as chronic pain, opioid use disorder or attention deficit/hyperactivity disorder. Although transdermal versions offer improved pharmacokinetic delivery as well as patient convenience with wear times of up to 7 days, they contain an increased drug payload which can often be a target for recreational drug abusers or subject to accidental pediatric exposure, particularly with infants and toddlers. Abuse of opioids, and in particular fentanyl abuse and overdose, continues to be an epidemic which can lead to the abuse of prescription transdermal fentanyl and other opioid containing transdermal products. According to the FDA, accidental exposure to medication is a leading cause of poisoning in children. Young children, in particular, have died or become seriously ill after being exposed to a skin patch containing fentanyl, a powerful opioid pain reliever. Children can overdose on new and used fentanyl patches by putting them in their mouth or sticking the patches on their skin. This can cause death by slowing the child's breathing and decreasing the levels of oxygen in their blood. Nutriband abuse-deterrent transdermal technology consists of a proprietary aversive agent coating that employs taste aversion to deter the oral abuse of and accidental exposure to transdermal opioid and stimulant patch products. Preliminary studies have shown that the coating is very difficult to scrape off and the technology has a patented immediate and extended-release profile which presents an additional layer of deterrence to prevent the aversive layer from easily being washed off in an attempt to separate the drug from the aversive agents. The company engaged Rocky Mountain Poison & Drug Safety (RMPDS), a division of Denver Health and Hospital Authority, Denver, Colorado to determine the incidence of abuse and accidental pediatric exposure of transdermal patches containing drugs of abuse in the United States based on poison center data for the surveillance period 2018-2022. RMPDS utilized the Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS®) System, a surveillance system that collects real-world safety and effectiveness data about prescription drugs. Key findings from the study include: Major medical outcome or death resulted from a notable proportion of fentanyl and buprenorphine patch intentional exposures and accidental pediatric exposures, Two deaths were reported due to abuse of fentanyl transdermal patches, Oral abuse accounted for 62.5% of all intentional abuse/misuse event reports for fentanyl patches (85.3% of non-dermal routes of abuse), and A notable proportion of accidental pediatric exposures to transdermal formulations resulted in major medical outcomes (fentanyl patches: 10.1%, buprenorphine patches: 16.7%). Annonce • Mar 05
Nutriband Inc. Announces Data on the Incidence of Transdermal Patch Abuse and Accidental Pediatric Exposure Will Be Presented At the 2024 American Academy of Pain Medicine Annual Meeting Nutriband Inc. announced that data on the incidence of transdermal patch abuse and accidental pediatric exposure will be presented at the 2024 American Academy of Pain Medicine (AAPM) Annual Meeting to be held in Scottsdale, ArizonaMarch 7-10, 2024. The company engaged Rocky Mountain Poison & Drug Safety (RMPDS), a division of Denver Health and Hospital Authority, Denver, Colorado to determine the incidence of abuse and accidental pediatric exposure of transdermal patches containing drugs of abuse in the United States. RMPDS utilized the Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS®) System, a surveillance system that collects real-world safety and effectiveness data about prescription drugs. Transdermal patches are designed to provide an alternative route of administration for opioid or stimulant drugs that are prescribed for treatment of conditions such as chronic pain, opioid use disorder or attention deficit/hyperactivity disorder. Although transdermal versions offer improved pharmacokinetic delivery as well as patient convenience with wear times of up to 7 days, they contain an increased drug payload which can often be a target for recreational drug abusers or subject to accidental pediatric exposure, particularly with infants and toddlers. Abuse of opioids, and in particular fentanyl abuse and overdose, continues to be an epidemic which can lead to the abuse of prescription transdermal fentanyl and other opioid containing transdermal products. According to the FDA, accidental exposure to medication is a leading cause of poisoning in children. Young children, in particular, have died or become seriously ill after being exposed to a skin patch containing fentanyl, a powerful opioid pain reliever. Children can overdose on new and used fentanyl patches by putting them in their mouth or sticking the patches on their skin. This can cause death by slowing the child's breathing and decreasing the levels of oxygen in their blood. Nutriband is developing its proprietary Aversa abuse deterrent transdermal technology which can be incorporated into any transdermal patch that contains any drug with a risk of abuse, misuse or accidental exposure. Its Aversa product development pipeline includes abuse deterrent versions of currently approved and marketed transdermal patches containing fentanyl, buprenorphine and methylphenidate which are labeled with FDA-required warnings for the risk of abuse and misuse, as well as warnings against accidental exposure. Nutriband's AVERSA abuse-deterrent transdermal technology can be utilized to incorporate aversive agents into transdermal patches to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential. The AVERSA abuse-deterrent technology has the potential to improve the safety profile of transdermal drugs susceptible to abuse, such as fentanyl, while making sure that these drugs remain accessible to those patients who really need them. The technology is covered by a broad intellectual property portfolio with patents granted in the United States, Europe, Japan, Korea, Russia, Canada, Mexico, and Australia. New Risk • Jan 07
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 13% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$3.6m free cash flow). Share price has been highly volatile over the past 3 months (18% average weekly change). Earnings have declined by 16% per year over the past 5 years. Minor Risks Shareholders have been diluted in the past year (13% increase in shares outstanding). Revenue is less than US$5m (US$2.1m revenue). Market cap is less than US$100m (€22.7m market cap, or US$24.8m). Annonce • Dec 17
Nutriband Inc., Annual General Meeting, Jan 21, 2024 Nutriband Inc., Annual General Meeting, Jan 21, 2024, at 10:00 US Eastern Standard Time. Location: 400 West Church Street, City National Hourglass Room Orlando Florida United States Agenda: To elect six directors to the Corporation’s Board of Directors, each to hold office for a term expiring at the next Annual Meeting of Stockholders, or until his or her successor is elected and qualified, or until his or her earlier resignation or removal; to consider Ratification of Sadler, Gibb & Associates, LLC as the independent auditor to perform the audit of our consolidated financial statements for 2024; to hold an advisory vote to approve executive compensation; to hold an advisory vote on the frequency of future advisory votes on executive compensation; and to transact such other business as may properly come before the Annual Meeting and any adjournment or postponement thereof. Reported Earnings • Dec 14
Third quarter 2024 earnings released: US$0.23 loss per share (vs US$0.14 loss in 3Q 2023) Third quarter 2024 results: US$0.23 loss per share (further deteriorated from US$0.14 loss in 3Q 2023). Revenue: US$427.8k (down 31% from 3Q 2023). Net loss: US$1.76m (loss widened 64% from 3Q 2023). Annonce • Nov 29
Nutriband Inc. Expands its AI Kinesiology Tape Portfolio with the Launch of AI Tape Heating and Cooling Nutriband Inc. announced the launch of its new Heating and Cooling Kinesiology Tape as part of its Active Intelligence (AI Tape) Brand portfolio. AI Tape Heating and Cooling provides all of the stretch, support, and benefits of traditional kinesiology tape, plus pain-relieving ingredients that provide both heating and cooling sensation for the temporary relief of minor aches and pains of muscles and joints. The Heating and Cooling product marks AI Tape's second product launched in the year 2023. All AI Tape products are manufactured in the USA at Nutriband's facility in Cherryville, North Carolina. The new AI Tape products are available for purchase on Amazon and company website. Reported Earnings • Sep 12
Second quarter 2024 earnings released: US$0.11 loss per share (vs US$0.12 loss in 2Q 2023) Second quarter 2024 results: US$0.11 loss per share (improved from US$0.12 loss in 2Q 2023). Revenue: US$655.9k (up 44% from 2Q 2023). Net loss: US$829.2k (loss narrowed 20% from 2Q 2023). Annonce • Jul 28
Nutriband Inc. Launches AI Tape Brand Direct- to Consumer Offerings Nutriband Inc. announced the launch of its consumer sports recovery tape brand, Active Intelligence AI Tape ("AI Tape"), with products now available for purchase on Amazon and Activeintell.com. AI Tape is designed to combine many of the traditional benefits of kinesiology tape with the addition of clothing and therapeutic ingredients held in suspension with a proprietary adhesive mix. AI Tape is manufactured in the USA at the Company's Pocono Pharmaceutical facility in North Carolina.