Nutriband Closes $8.4M Private Placement for Commercial Development of Aversa(R) Fentanyl Transdermal Patch Through FDA Submission

Private Placement of $8.4 million has closed and will fund the commercial development of lead product AVERSA Fentanyl to NDA filing

Nutriband working to complete the commercial scale-up prior to performing the pivotal laboratory assessment and clinical study required for FDA approval

AVERSA Fentanyl being developed as 505(b)(2) NDA on single Phase 1 human abuse potential clinical study with no Phase 2 or 3 clinical trials needed.

ORLANDO, FL / ACCESSWIRE / April 24, 2024 / Nutriband Inc. (NASDAQ:NTRB)(NASDAQ:NTRBW), a company engaged in the development of prescription transdermal pharmaceutical products, today announced that it has closed the $8.4 million private placement to fund the commercial development program for its lead product, AVERSA Fentanyl. 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.¹

Nutriband is currently working with its partner Kindeva Drug Delivery, a leading global contract development and manufacturing organization, 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.

With this latest round of funding and based on progress made on the commercial transdermal manufacturing process scale-up to date, Nutriband is pushing towards the following development milestones:

• FDA Pre-IND Meeting
• Pivotal Laboratory Manipulation and Extraction Study
• FDA IND Filing
• Pivotal Human Abuse Potential Clinical Study
• New Drug Application Filing 505(b)(2) NDA
• FDA Review and Approval (Expedited)

The Company is targeting Q1 of 2025 to file its NDA for marketing approval.

Once the final commercial product manufacturing process is completed, Nutriband intends to perform the pivotal laboratory and clinical evaluations to demonstrate the abuse-deterrent properties of AVERSA Fentanyl, in compliance with FDA Guidance for Industry Abuse-Deterrent Opioids - Evaluation and Labeling. Nutriband intends to obtain agreement on the pivotal studies required for approval in an FDA Pre-Investigational New Drug Application (Pre-IND) Meeting.