0001213900-24-003023.txt : 20240111 0001213900-24-003023.hdr.sgml : 20240111 20240111170746 ACCESSION NUMBER: 0001213900-24-003023 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 14 CONFORMED PERIOD OF REPORT: 20240104 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20240111 DATE AS OF CHANGE: 20240111 FILER: COMPANY DATA: COMPANY CONFORMED NAME: NutriBand Inc. CENTRAL INDEX KEY: 0001676047 STANDARD INDUSTRIAL CLASSIFICATION: ORTHOPEDIC, PROSTHETIC & SURGICAL APPLIANCES & SUPPLIES [3842] ORGANIZATION NAME: 08 Industrial Applications and Services IRS NUMBER: 811118176 STATE OF INCORPORATION: NV FISCAL YEAR END: 0131 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-40854 FILM NUMBER: 24529901 BUSINESS ADDRESS: STREET 1: 121 S. ORANGE AVE. STREET 2: SUITE 1500 CITY: ORLANDO STATE: FL ZIP: 32801 BUSINESS PHONE: 407 377-6695 MAIL ADDRESS: STREET 1: 121 S. ORANGE AVE. STREET 2: SUITE 1500 CITY: ORLANDO STATE: FL ZIP: 32801 FORMER COMPANY: FORMER CONFORMED NAME: Nutriband Inc. DATE OF NAME CHANGE: 20160601 8-K 1 ea191528-8k_nutriband.htm CURRENT REPORT
false 0001676047 0001676047 2024-01-04 2024-01-04 0001676047 us-gaap:CommonStockMember 2024-01-04 2024-01-04 0001676047 NTRB:WarrantsMember 2024-01-04 2024-01-04 iso4217:USD xbrli:shares iso4217:USD xbrli:shares

 

 

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): January 4, 2024

 

Nutriband Inc.

 

Nevada   001-40854   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.

 

See Press Release attached as Exhibit 99.1.

 

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 Nutriband Press Release dated January 4, 2023
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: January 11, 2024 By: /s/ Gareth Sheridan
    R: Gareth Sheridan
    Chief Executive Officer

 

 

2

 

 

 

 EX-99.1 2 ea191528ex99-1_nutriband.htm NUTRIBAND PRESS RELEASE DATED JANUARY 4, 2023

Exhibit 99.1

 

NUTRIBAND SIGNS COMMERCIAL DEVELOPMENT AND CLINICAL SUPPLY AGREEMENT WITH KINDEVA DRUG DELIVERY FOR AVERSA™ FENTANYL, AN ABUSE DETERRENT FENTANYL PATCH

 

ORLANDO, FL / ACCESSWIRE / January 4, 2024 / Nutriband Inc. (NASDAQ:NTRB) (NASDAQ:NTRBW), a company engaged in the development of transdermal pharmaceutical products, today announced it has signed a commercial development and clinical supply agreement for their lead product, Aversa™ Fentanyl, with their partner, Kindeva Drug Delivery, a leading global contract development and manufacturing organization (CDMO) focused on drug-device combination products. Under this agreement, Kindeva will perform commercial manufacturing process development and manufacture clinical supplies for the human abuse liability clinical study required by the FDA in support of a New Drug Application (NDA). This new agreement replaces the previous feasibility agreement between the two companies which was focused on adapting Kindeva’s commercial transdermal manufacturing process to incorporate AVERSA™ abuse deterrent transdermal technology.

 

AVERSA™ Fentanyl combines Nutriband’s proprietary AVERSA™ abuse-deterrent transdermal technology with Kindeva’s FDA-approved transdermal fentanyl patch system with 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 $80M - $200M.1

 

“Execution of this commercial development agreement with our partner, Kindeva, will enable us to rapidly commercialize AVERSA™ Fentanyl and capitalize on its significant market potential. 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,” said Gareth Sheridan, CEO, Nutriband.

 

“Transdermal drug-delivery technologies continue to create positive health outcomes for patients globally,” said Kindeva Global Chief Commercial Officer David Stevens. “Kindeva brings more than a half a century of expertise in transdermal capabilities and innovation, and we appreciate Nutriband’s expertise and partnership in this next step in development to continue to bring new solutions to patients.”

 

 

1Health Advances Aversa Fentanyl market analysis report 2022

 

 

 

 

About AVERSA™ Abuse Deterrent Transdermal Technology

 

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.

 

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.

 

About Kindeva Drug Delivery

 

Kindeva is a global contract development manufacturing organization focused on drug-device combination products. Kindeva develops and manufactures products across a broad range of complex drug-delivery formats, including pulmonary & nasal, injectable, and transdermal . Its service offerings span early-stage feasibility through commercial scale drug product fill-finish, container closure system manufacturing, and drug-device product assembly. Kindeva serves a global client base from its nine manufacturing and research and development facilities located in the U.S. and U.K. For more information, please visit www.kindevadd.com.

 

2

 

 

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, 2023 and Forms 10-Q, 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.

 

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, 2022 and Forms 10-Q, 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.

 

For more information, contact:

 

Investor Relations

 

RedChip Companies

 

Dave Gentry

 

NTRB@redchip.com

 

1-800-RED-CHIP (733-2447)

 

407-491-4498

 

 

3

 

 

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