• Nutriband’s AVERSA(TM) technology is advancing toward commercialization as the first abuse-deterrent transdermal fentanyl patch
• Recent FDA regulatory changes underscore the urgent need for safer opioid delivery methods and responsible prescribing
• Strategic milestones with partner Kindeva and a strengthened global IP portfolio position Nutriband for long-term growth

A Market Demanding Safer Opioid Solutions

The opioid crisis remains a critical public health challenge in the U.S. and globally, prompting a series of new regulatory measures designed to improve safety and reduce misuse. In early 2025, the FDA approved Journavx (suzetrigine), a first-in-class non-opioid painkiller offering patients safer alternatives to opioids. Additionally, opioid manufacturers are now required to include prepaid mail-back envelopes for safe disposal of unused medications, while enhanced boxed warnings on opioid labels further reinforce the dangers of misuse, addiction, and overdose.

These regulatory shifts reflect a growing emphasis on not only expanding non-opioid options but also improving the safety of existing opioid therapies, creating a compelling market opportunity for innovative technologies that deter abuse without compromising patient access.

Nutriband’s Unique Approach to Abuse-Deterrent Delivery

Nutriband (NASDAQ: NTRB) is at the forefront of this evolving landscape with its proprietary AVERSA(TM) technology, which embeds aversive agents into transdermal drug patches to deter misuse, diversion, and accidental exposure. The company’s lead product, AVERSA(TM) Fentanyl, combines Nutriband’s abuse-deterrent formulation with Kindeva Drug Delivery’s FDA-approved fentanyl patch, aiming to become the world’s first opioid pain patch with built-in abuse-deterrent properties.

According to Nutriband’s shareholder letter in April, AVERSA(TM) Fentanyl could achieve peak annual sales between $80 million and $200 million, with its next candidate, AVERSA(TM) Buprenorphine, targeting peak sales of $70 million to $130 million. Importantly, recent commercial cost analyses have confirmed the economic viability of integrating AVERSA(TM) into existing FDA-approved transdermal products, positioning NTRB to capture high-margin opportunities in a market desperate for safer pain management solutions.

Progress Toward Commercialization

In 2024, Nutriband made significant strides in scaling up its manufacturing processes and strengthening its supply chain infrastructure to meet FDA regulatory standards. A major milestone was achieved with Kindeva Drug Delivery formalizing an exclusive partnership, enabling NTRB to shift from feasibility to full-scale commercial development of AVERSA(TM). This collaboration not only validates the technology but also reduces dilution risks for shareholders, as highlighted by the company’s successful $8.4 million private placement in April 2024.

Looking ahead, Nutriband is preparing to enter pivotal Human Abuse Liability (“HAL”) clinical trials, a key step toward filing a New Drug Application (“NDA”) with the FDA. The company’s global intellectual property portfolio, now covering 46 countries including recent approvals in China and the U.S., further cements its leadership in abuse-deterrent transdermal drug delivery.

A Strategic Outlook for 2025 and Beyond

Nutriband’s ambitions for 2025 include advancing AVERSA(TM) Fentanyl through clinical trials, exploring international licensing opportunities, and expanding its commercial manufacturing collaborations. Notably, its Pocono Pharma subsidiary continues to generate strong revenue from contract manufacturing services, particularly through its growing partnership with KT Tape, the world leader in kinesiology tape.

As opioid safety regulations tighten and the demand for abuse-deterrent therapies increases, Nutriband is well-positioned to capitalize on these trends. With a unique technology platform, strategic alliances, and a robust IP foundation, the company stands out as a promising player addressing one of the pharmaceutical industry’s most urgent challenges.

For more information, visit the company’s website at www.Nutriband.com.

NOTE TO INVESTORS: The latest news and updates relating to NTRB are available in the company’s newsroom at https://ibn.fm/NTRB

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