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

840万美元的私人配售已经结束，并将为铅产品AVERSA芬太尼的商业开发提供资金，以提交保密协议

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

在进行FDA批准所需的关键实验室评估和临床研究之前，Nutriband致力于完成商业规模扩大

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.

AVERSA芬太尼被开发为505（b）（2）NDA，用于单阶段1人类滥用潜在临床研究，无需2期或3期临床试验。

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.

佛罗里达州奥兰多/ACCESSWIRE/2024年4月24日/从事处方透皮药品开发的公司Nutriband Inc.（纳斯达克：NTRB）（纳斯达克：NTRBW）今天宣布，已完成840万美元的私募，为其主导产品AVERSA™芬太尼的商业开发计划提供资金。

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.

AVERSA芬太尼有可能成为世界上第一个阻止阿片类药物滥用的贴剂，旨在阻止滥用和误用，并降低芬太尼透皮贴剂意外暴露的风险。AVERSA芬太尼有可能在美国达到8000万至2亿美元的年销售额峰值。

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..

Nutriband目前正在与其合作伙伴Kindeva Drug Delivery（一家领先的全球合同开发和制造组织）合作，开发最终产品的商业规模制造工艺，该工艺将Nutriband的AVERSA™防滥用透皮技术纳入Kindeva的FDA批准的芬太尼透皮贴剂系统。

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:

凭借这一最新一轮资金，并基于迄今为止在商业透皮制造工艺规模方面取得的进展，Nutriband正在朝着以下发展里程碑迈进：

FDA Pre-IND Meeting

美国食品药品监督管理局IND前会议

Pivotal Laboratory Manipulation and Extraction Study

关键的实验室操作和提取研究

FDA IND Filing

美国食品药品监督管理局IND备案

Pivotal Human Abuse Potential Clinical Study

关键的人类虐待潜在临床研究

New Drug Application Filing 505(b)(2) NDA

新药申请备案505（b）（2）NDA

FDA Review and Approval (Expedited)

FDA审查和批准（加急）

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

该公司计划在2025年第一季度将其NDA提交上市审批。

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.

一旦最终的商业产品制造过程完成，Nutriband打算进行关键的实验室和临床评估，以证明AVERSA芬太尼的滥用威慑特性，符合FDA关于行业滥用威慑阿片类药物-评估和标签的指导。

Nutriband intends to obtain agreement on the pivotal studies required for approval in an FDA Pre-Investigational New Drug Application (Pre-IND) Meeting..

Nutriband打算就FDA新药申请预研究（IND）会议批准所需的关键研究达成协议。

The pivotal laboratory assessment to be conducted is a series of in vitro manipulation and extraction studies designed to determine if the potentially abuse-deterrent properties of the product can be defeated or compromised based on physical and chemical manipulation of the product. Preliminary studies conducted to date have shown that the AVERSA technology is very difficult to defeat by various physical or chemical means..

要进行的关键实验室评估是一系列体外操作和提取研究，旨在确定产品的潜在滥用威慑特性是否可以基于产品的物理和化学操作而被击败或受损。迄今为止进行的初步研究表明，AVERSA技术很难通过各种物理或化学手段击败。

The pivotal clinical study is a human abuse potential study performed to assess the impact of the potentially abuse-deterrent properties in a drug-experienced, recreational user population. The human abuse potential study is a randomized, double-blind, placebo-controlled and positive controlled crossover study comparing AVERSA Fentanyl to the currently marketed fentanyl patch which does not contain abuse-deterrent technology.

关键的临床研究是一项人类滥用潜力研究，旨在评估潜在滥用威慑特性对有毒品经历的娱乐性使用者人群的影响。人类滥用潜力研究是一项随机，双盲，安慰剂对照和阳性对照的交叉研究，比较了AVERSA芬太尼与目前上市的不含滥用威慑技术的芬太尼贴剂。

The success of the human abuse potential study is based on the assessment of drug liking using various instruments that are predictive of the likelihood of abuse. Nutriband will file an Investigational New Drug (IND) application with the FDA prior to conducting the Phase 1 human abuse potential clinical study.

人类滥用潜力研究的成功是基于使用各种预测滥用可能性的工具对药物喜好的评估。在进行第一阶段人类滥用潜在临床研究之前，Nutriband将向FDA提交一份研究性新药（IND）申请。

The IND will include the chemistry, manufacturing, and controls (CMC) information for the commercial product as well as the clinical study protocol for the human abuse potential study..

IND将包括商业产品的化学、制造和控制（CMC）信息以及人类滥用潜力研究的临床研究方案。

Following a successful Phase 1 clinical abuse potential study, Nutriband intends to file a 505(b)(2) New Drug Application (NDA) to the FDA for marketing approval of AVERSA™ Fentanyl. The 505(b)(2) NDA regulatory pathway limits the development required for products that contain drugs that have already been approved, and allows applicants to reference data already on file at the FDA.

在成功进行第一阶段临床滥用潜力研究后，Nutriband打算向FDA提交505（b）（2）新药申请（NDA），以获得AVERSA™芬太尼的上市批准。505（b）（2）NDA监管途径限制了含有已被批准药物的产品所需的开发，并允许申请人参考已经在FDA存档的数据。

As a result, the NDA application will be primarily based on a single Phase 1 human abuse potential clinical study with no Phase 2 or 3 clinical trials needed..

因此，NDA申请将主要基于单一的1期人类虐待潜在临床研究，不需要2期或3期临床试验。

The AVERSA™ Fentanyl NDA has the potential to receive an expedited review by FDA as has been granted for certain abuse-deterrent oral opioid products, which shortens the regulatory review period to six months from the conventional 10-month FDA review cycle for NDAs.

AVERSA™芬太尼NDA有可能接受FDA对某些阻止滥用的口服阿片类药物产品的快速审查，这将监管审查期从传统的10个月FDA NDA审查周期缩短到6个月。

Combined, the clinical development and regulatory path for AVERSA™ Fentanyl is substantially limited compared to conventional pharmaceutical product development, requiring only a single clinical trial and, following a limited NDA pathway, undergoing an expedited review by the FDA.

综上所述，与传统的药品开发相比，AVERSA™芬太尼的临床开发和监管路径受到很大限制，只需要一次临床试验，并且遵循有限的NDA途径，接受FDA的快速审查。

Nutriband is developing its proprietary AVERSA™ abuse deterrent transdermal technology to be incorporated into any transdermal patch that contains a drug with a risk of abuse, misuse, or accidental exposure. The Company's AVERSA™ product development pipeline includes abuse deterrent versions of currently approved and marketed transdermal patches containing fentanyl, buprenorphine and methylphenidate which are labeled with FDA-required warnings for the risk of abuse and misuse, as well as warnings against accidental exposure..

Nutriband正在开发其专有的AVERSA™防滥用透皮技术，将其纳入任何含有滥用，误用或意外暴露风险的药物的透皮贴剂中。该公司的AVERSA™产品开发渠道包括目前批准和销售的含有芬太尼、丁丙诺啡和哌醋甲酯的透皮贴剂的滥用威慑版本，贴有FDA要求的滥用和误用风险警告，以及意外接触警告。

1 Health Advances Aversa Fentanyl market analysis report 2022

1 Health Advances Aversa芬太尼2022年市场分析报告

About AVERSA™ Abuse-Deterrent Transdermal Technology

关于AVERSA™防虐待透皮技术

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.

Nutriband的AVERSA™防滥用透皮技术可用于将厌恶剂掺入透皮贴剂中，以防止滥用、转移、误用和意外暴露具有滥用潜力的药物。AVERSA™防滥用技术有可能改善易受滥用的透皮药物（如芬太尼）的安全性，同时确保真正需要这些药物的患者仍然可以使用这些药物。

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..

该技术涵盖了广泛的知识产权组合，并在美国、欧洲、日本、韩国、俄罗斯、加拿大、墨西哥和澳大利亚获得了专利。

About Nutriband Inc.

关于Nutriband股份有限公司。

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..

我们主要从事透皮药品组合的开发。我们正在开发的主导产品是一种滥用威慑芬太尼贴剂，结合了我们的AVERSA™滥用威慑技术。AVERSA™技术可以整合到任何透皮贴剂中，以防止滥用、误用、转移和意外暴露具有滥用潜力的药物。

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.

公司网站为www.nutriband.com。公司网站或任何其他网站中包含或衍生的任何材料均不属于本新闻稿的一部分。

Forward-Looking Statements

前瞻性声明

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.

本新闻稿中包含的某些声明，包括但不限于包含“相信”、“预期”、“期望”和类似含义的声明，构成1995年《私人证券诉讼改革法》含义内的“前瞻性声明”。此类前瞻性陈述涉及已知和未知的风险和不确定性。

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 .

由于多种因素的影响，公司的实际结果可能与前瞻性声明中预期的结果存在重大差异，包括公司开发拟议的滥用威慑芬太尼透皮系统和其他拟议产品的能力，获得滥用技术专利保护的能力，获得开发产品和进行必要临床测试所需资金的能力，获得联邦食品和药物管理局批准在美国销售其可能开发的任何产品的能力，以及获得在其他国家（包括欧洲国家）销售任何产品所需的任何其他监管批准的能力，销售其可能开发的任何产品的能力，创造、维持、管理或预测其增长的能力；吸引和留住关键人员的能力；公司经营战略或发展计划的变更；竞争；业务中断；不利的宣传以及国际、国家和地方的一般经济和市场状况和风险，通常与资本不足的发展中公司有关，以及公司s-1表格、10-K表格（截至2023年1月31日的年度）中“风险因素”和“管理层对财务状况和经营成果的讨论和分析”中包含的风险，2023年4月26日存档，10-Q表格存档。