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SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549 

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of

the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported); February 13, 2025

 

Nutriband Inc.

 

Nevada   000-40854   81-1118176
(State or Other Jurisdiction
of Incorporation)
  (Commission File Number)   (I.R.S. Employer
Identification No.)

 

121 S. Orange Ave. Suite 1500

Orlando, Florida

  32801
(Address of Principal Executive Offices)   (Zip Code)

 

(407) 377-6695

Registrant’s Telephone Number, Including Area Code

 

 

(Former name or former address, if changed since last report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

  

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). 

 

Emerging growth company 

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. 

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class   Trading Symbol(s)   Name of each exchange on which registered
Common Stock    NTRB   The Nasdaq Stock Market LLC 
Warrants   NTRBW   The Nasdaq Stock Market LLC

 

 

 

 

 

 

Item 7.01. Regulation FD Disclosure.

 

Nutriband Inc., a company engaged in the development of prescription transdermal pharmaceutical products, today announced that it has signed an addendum to the Commercial Development and Clinical Supply Agreement for its lead product, Aversa™ Fentanyl, that it has in place with its partner, Kindeva Drug Delivery, a leading global contract development and manufacturing organization (CDMO) focused on drug-device combination products.

 

Nutriband and Kindeva have revised their agreement to formalize their exclusive product development partnership and long-term commitment based on shared development costs in exchange for milestone payments. Nutriband’s AVERSA™ 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.

 

Item 9.01 Financial Statements and Exhibits

 

(d) Exhibits

 

The following exhibits are being filed with this Current Report on Form 8-K:

 

99.1   Press Release issued February 13, 2025
104   Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

1

 

 

SIGNATURES

 

PURSUANT TO THE REQUIREMENTS OF THE SECURITIES EXCHANGE ACT OF 1934, THE REGISTRANT HAS DULY CAUSED THIS REPORT TO BE SIGNED ON ITS BEHALF BY THE UNDERSIGNED THEREUNTO DULY AUTHORIZED.

 

  NUTRIBAND, INC.
     
Date: February 13, 2025 By: /s/ Gareth Sheridan
    R: Gareth Sheridan
    Chief Executive Officer

 

 

2

 

Exhibit 99.1

 

 

Nutriband and Kindeva formalize exclusive product development partnership and long-term commitment based on shared development costs in exchange for milestone payments

 

Nutriband is partnering with Kindeva Drug Delivery to develop Aversa™ Fentanyl which combines Nutriband’s Aversa™ abuse-deterrent technology with Kindeva’s FDA-approved fentanyl patch.

 

ORLANDO, Fla., Feb. 13, 2025 (GLOBE NEWSWIRE) -- Nutriband Inc. (NASDAQ:NTRB)(NASDAQ:NTRBW), a company engaged in the development of prescription transdermal pharmaceutical products, today announced that it has signed an addendum to the Commercial Development and Clinical Supply Agreement for its lead product, Aversa™ Fentanyl, that it has in place with its partner, Kindeva Drug Delivery, a leading global contract development and manufacturing organization (CDMO) focused on drug-device combination products.

 

Nutriband and Kindeva have revised their agreement to formalize their exclusive product development partnership and long-term commitment based on shared development costs in exchange for milestone payments.

 

Nutriband’s AVERSA™ 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.

 

Nutriband’s 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.

 

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.

 

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

 

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.

 

1Health Advances Aversa Fentanyl market analysis report 2022

 

 

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Cover
Feb. 13, 2025
Document Type 8-K
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Entity File Number 000-40854
Entity Registrant Name Nutriband Inc
Entity Central Index Key 0001676047
Entity Tax Identification Number 81-1118176
Entity Incorporation, State or Country Code NV
Entity Address, Address Line One 121 S. Orange Ave. Suite 1500
Entity Address, City or Town Orlando
Entity Address, State or Province FL
Entity Address, Postal Zip Code 32801
City Area Code 407
Local Phone Number 377-6695
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Pre-commencement Issuer Tender Offer false
Entity Emerging Growth Company true
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Common Stock [Member]  
Title of 12(b) Security Common Stock 
Trading Symbol NTRB
Security Exchange Name NASDAQ
Warrants  
Title of 12(b) Security Warrants
Trading Symbol NTRBW
Security Exchange Name NASDAQ

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