Nutriband is targeting a 505(b)(2) NDA to the FDA for marketing approval of AVERSA™ Fentanyl in Q1 2025
ORLANDO, FL / ACCESSWIRE / April 19, 2024 / Nutriband Inc. (NASDAQ:NTRB)(NASDAQ:NTRBW), a company engaged in the development of abuse deterrent pharmaceutical products announced that it has entered into definitive securities purchase agreements for the purchase and sale of an aggregate of 2,100,000 shares of common stock (the "Shares"), at a purchase price of $4 per share of common stock; for each Share of common stock purchased the investor receives a five-year warrant to purchase two shares of common stock. The exercise price of the Warrants is $6.43 per share. The private placement is expected to close on or about April 19, 2024, subject to the satisfaction of customary closing conditions.
The primary use of proceeds will be for completing the remaining clinical development of AVERSA Fentanyl and submission of its NDA with the FDA for marketing approval. AVERSA Fentanyl has the potential to become the world's first opioid patch with abuse deterrent properties and is estimated it could reach peak annual US sales of $80 million to $200 million.1
"The completion of this private placement should provide sufficient funding through our NDA filing for AVERSA Fentanyl with the FDA for marketing approval. This is a significant step for the company as we target this submission in Q1 2025," Said Gareth Sheridan, CEO.
The Securities being sold in the private placement have not been registered under the Securities Act of 1933, as amended, or state securities laws and may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from such registration requirements. The Company has agreed to file a registration statement with the SEC covering the resale of the Shares and the shares underlying the Warrants issuable in connection with the Purchase Agreements.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.
1 Health Advances Aversa Fentanyl market analysis report 2022
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, 2023, filed April 26, 2023, the Forms 10-Q's filed subsequent to the Form 10-K in 2023, 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:
RedChip Companies, Inc.
Email: NTRB@Redchip.com
Phone: 1-407-644-4256
Address:
431 E Horatio Ave, Suite #100
Maitland, FL 32751
Nutriband Inc.
Phone: 407-377-6695
Email: Support@nutriband.com
SOURCE: Nutriband Inc.
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