ORLANDO, Fla., April 30, 2025 (GLOBE NEWSWIRE) -- Nutriband Inc. (NASDAQ:NTRB)(NASDAQ:NTRBW) today announced that CEO Gareth Sheridan has published a letter to shareholders providing insights on achievements and milestones through 2024 and the potential outlook for 2025. The full text of the letter is below.
Dear Shareholders,
Following the filing of our annual report as we wrap up a successful year packed with milestones and advances towards the commercialization of our AVERSA technology, the entire team at Nutriband would like to extend our warmest appreciation to all of you for your continued support throughout 2024 and into 2025.
Many of you have been with us from the beginning and many more joined our mission to change the pharmaceutical industry for the better by developing our Aversa technology designed to improve the safety of easily abused transdermal drugs, such as pain medications, while making them available to patients who need them. Pain patients have been struggling with inadequate care for too long, and they deserve to be able to access the medication they need. Aversa gives them this access. Today we are on track to be the world's first and only abuse deterrent technology in the transdermal space targeting abusable medications such as fentanyl and buprenorphine.
Nutriband is primarily focused on working with our partner Kindeva Drug Delivery, a leading global contract development and manufacturing organization focused on drug-device combination products, to develop our lead product, AVERSA™ Fentanyl, which incorporates Nutriband's AVERSA™ abuse-deterrent transdermal technology into Kindeva's FDA-approved transdermal fentanyl patch.
AVERSA Fentanyl has the potential to become the world's first opioid pain patch with abuse deterrent properties and is estimated to potentially reach peak annual sales of $80M - $200M. In addition, AVERSA Buprenorphine, our next candidate for AVERSA is projected to reach peak annual sales of $70M - $130M. Nutriband recently performed an extensive evaluation of the commercial cost of goods of incorporating the Aversa technology into existing FDA-approved transdermal patches and have confirmed the viability of achieving high margins that are typically found in NDA pharmaceutical products.
This past year we have made significant strides in the development and scale-up of the manufacturing process to bring the AVERSA technology closer towards commercialization. This has involved the development and refinement of our proprietary technology for commercial scale manufacturability as well as the establishment of the commercial supply chain and validation of the analytical methods required to meet FDA regulatory standards for a pharmaceutical product.
The new year has already been highlighted by a significant milestone with our partner Kindeva Drug Delivery to formalize our exclusive product development partnership and long-term commitment based on shared development costs in exchange for milestone payments. It solidifies a transition to commercial scale development for AVERSA Fentanyl. We have confidently shifted our focus from feasibility towards commercial development in support of an NDA filing and commercialization. This was a very strong show of support from our partner Kindeva which also allowed us to reduce the impact of dilution to our existing shareholders which I stress has been and will remain a core focus of the company. This was evident through our raise of $8.4M USD in April 2024 in a non-brokered private placement primarily through existing shareholders.
In addition, we continued to further expand the worldwide intellectual property portfolio for our Aversa™ abuse deterrent technology, with approvals in China and its territories, Hong Kong and Macao, and a new patent recently allowed in the United States. This improves our position to bring our leading abuse deterrent platform to market and we are now patented in 46 countries around the world. While initially concentrating on the US market, the unmet medical need for adequate pain management is a global problem, and our goal is to make AVERSA a global solution strategically targeting all major medical markets in the world.
Our 2025 goals are ambitious yet achievable, focused on getting into the clinic to evaluate our lead product, Aversa Fentanyl, in a pivotal Human Abuse Liability (HAL) clinical trial to support an NDA filing. This involves manufacturing clinical supplies using a commercial scale process and filing an Investigational New Drug application with the FDA. We are also excited to explore new potential partnerships, internationally for our AVERSA intellectual property and will be turning our focus to potential licensing and partnership opportunities as we near closer to filing our NDA with the FDA.
Financially, the team is excited by strong revenue in our Pocono Pharma subsidiary for our kinesiology tape contract manufacturing services. We strongly believe that 2025 is shaping up to be our best year on record at Pocono Pharma due to our expanding manufacturing collaboration with KT Tape, the world leader in kinesiology tape.
If you haven't already taken a moment to sign up for our email alerts, be sure to do so by visiting our website: www.Nutriband.com. Signing up will ensure that you receive the latest news and announcements as they become available.
Your continued support and belief in our vision have been pivotal to our reaching these milestones and others as we forge ahead. We remain committed to delivering innovative solutions and generating value for our shareholders. Thank you for your trust, confidence and investment in Nutriband Inc.
Sincerely,
Gareth Sheridan
CEO, Nutriband Inc.
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.
About Nutriband Inc.
We are primarily engaged in the development of a portfolio of transdermal pharmaceutical products. Our lead product under development is an abuse-deterrent fentanyl patch incorporating our AVERSA™ abuse-deterrent technology. AVERSA™ technology can be incorporated into any transdermal patch to prevent the abuse, misuse, diversion, and accidental exposure of drugs with abuse potential.
The Company's website is www.nutriband.com. Any material contained in or derived from the Company's websites or any other website is not part of this press release.
Forward-Looking Statements
Certain statements contained in this press release, including, without limitation, statements containing the words ‘'believes," "anticipates," "expects" and words of similar import, constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve both known and unknown risks and uncertainties. The Company's actual results may differ materially from those anticipated in its forward-looking statements as a result of a number 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 develop, 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 international, national and local general economic and market conditions and risks generally associated with an undercapitalized developing company, as well as the risks contained under "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in the Company's Form S-1, Form 10-K for the year ended January 31, 2025, filed April 28, 2025, the Forms 10-Q's filed subsequent to the Form 10-K in 2025, and the Company's other filings with the Securities and Exchange Commission. Except as required by applicable law, we undertake no obligation to revise or update any forward-looking statements to reflect any event or circumstance that may arise after the date hereof.
Contact Information:
Nutriband Inc.
Phone: 407-377-6695
Email: [email protected]
SOURCE: Nutriband Inc.
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