The World Health Organization (WHO) recently reaffirmed the spread of new clade Ib Mpox a public health emergency of international concern (PHEIC): second Mpox-related WHO PHEIC declaration in two years

世界卫生组织（WHO）最近重申，新分支Ib型猴痘的传播是国际关注的突发公共卫生事件（PHEIC）：两年内的第二次猴痘相关的世卫组织PHEIC声明。

Clade Ib Mpox cases detected in several countries in Central and Eastern Africa as well as China, Thailand, Singapore, India, England, parts of Europe and the Middle East, Canada and the United States

在中非和东非以及中国、泰国、新加坡、印度、英国、欧洲和中东部分地区、加拿大和美国检测到进化枝Ib猴痘病例。

Tolerability of TNX‐801 vaccination in immune-compromised animal models supports clinical development

免疫功能低下动物模型中TNX‐801疫苗的耐受性支持临床开发。

CHATHAM, N.J., March 10, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced it has been awarded a grant from the Medical CBRN Defense Consortium (MCDC) to support the development of TNX-801 (recombinant horsepox virus, live vaccine).

新泽西州查塔姆，2025年3月10日（环球新闻社）——Tonix制药控股公司（纳斯达克股票代码：TNXP）（Tonix或公司），一家拥有上市产品和开发候选药物管线的完全整合型生物制药公司，今日宣布已获得医疗化学、生物、放射与核防御联盟（MCDC）的拨款，以支持TNX-801（重组马痘病毒，活疫苗）的开发。

MCDC is a consortium of industrial, academic, and non-profit entities that supports the U.S. government in meeting military requirements for medical products to protect against chemical, biological, radiological and nuclear (CBRN) threats. TNX-801 is in development as an mpox and smallpox vaccine with the potential to be delivered via innovative alternative methods to improve patient compliance, ease of use and tolerability.

MCDC是一个由工业、学术和非营利实体组成的联盟，支持美国政府满足针对化学、生物、放射性和核（CBRN）威胁的医疗产品军事需求。TNX-801正在开发作为猴痘和天花疫苗，具有通过创新替代方法递送的潜力，以提高患者的依从性、使用便利性和耐受性。

The MCDC grant will allow for further comprehensive market analyses, target market identification and commercialization planning, including for both private and government markets..

MCDC 拨款将允许进行更全面的市场分析、目标市场识别和商业化规划，包括私有和政府市场。

“We are excited by the opportunity to collaborate with MCDC and are thankful for their support of our vaccine candidate,” said Seth Lederman, M.D., President, and Chief Executive Officer of Tonix. “TNX-801 offers an appealing target product profile, requiring just a single dose for durable, long-term protection, with favorable shipping and storage requirements.

“我们对与MCDC合作的机会感到兴奋，并感谢他们对我们疫苗候选产品的支持，”Tonix公司总裁兼首席执行官Seth Lederman博士表示。“TNX-801提供了一个极具吸引力的目标产品特性，只需单剂量即可实现持久的长期保护，同时具备良好的运输和储存要求。”

With a significant global unmet need, TNX-801 is in a strong position to make a potential impact towards preventing mpox and controlling mpox epidemics.”.

由于全球存在显著的未满足需求，TNX-801 有潜力在预防猴痘和控制猴痘流行方面产生重要影响。

TNX-801 is an attenuated live-virus vaccine based on synthesized horsepox that has been shown to provide single-dose immune protection against a monkeypox challenge with better tolerability than 20th century vaccinia live-virus vaccines in animals. TNX-801 has previously been shown to protect animals against lethal challenge with intratracheal clade I monkeypox virus..

TNX-801 是一种基于合成马痘病毒的减毒活病毒疫苗，已被证明在动物中单剂量免疫保护能够对抗猴痘攻击，并且比20世纪的牛痘活病毒疫苗具有更好的耐受性。TNX-801 之前已被证明可以保护动物免受气管内 I 型猴痘病毒的致死攻击。

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An outbreak of clade I mpox was declared a Public Health Emergency of International Concern (PHEIC) by the World Health Organization (WHO) in August of 2024 and reaffirmed in February 2025.

2024年8月，世界卫生组织（WHO）宣布I分支猴痘疫情为国际关注的突发公共卫生事件（PHEIC），并在2025年2月重申。

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Starting from an outbreak in the Democratic Republic of the Congo, clade I mpox has spread to sixteen Central African Countries and outside of Africa, including in China, Thailand, Singapore, India, England, parts of Europe and the Middle East, Canada and the United States.

从刚果民主共和国爆发开始，I型猴痘已传播到十六个中非国家，并扩散到非洲以外的地区，包括中国、泰国、新加坡、印度、英国、欧洲部分地区、中东、加拿大和美国。

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Tonix Pharmaceuticals Holding Corp.

Tonix制药控股公司

*

*

Tonix is a fully-integrated biopharmaceutical company focused on transforming therapies for pain management and vaccines for public health challenges. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to advance TNX-102 SL, a product candidate for the management of fibromyalgia, for which an NDA was submitted based on two statistically significant Phase 3 studies for the management of fibromyalgia and for which a PDUFA (Prescription Drug User Fee act) goal date of August 15, 2025 has been assigned for a decision on marketing authorization.

Tonix是一家完全整合的生物制药公司，专注于转化疼痛管理疗法和应对公共卫生挑战的疫苗。Tonix的研发组合专注于中枢神经系统（CNS）疾病。Tonix的首要任务是推进TNX-102 SL，这是一种用于治疗纤维肌痛的候选产品，已基于两项统计显著的三期临床研究提交新药申请（NDA），并被分配了2025年8月15日作为PDUFA（处方药使用者费用法案）目标日期以决定是否授予上市许可。

The FDA has also granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD).

美国食品药品监督管理局（FDA）还授予了TNX-102 SL治疗纤维肌痛的快速通道资格。TNX-102 SL还在美国国防部（DoD）资助的北卡罗来纳大学OASIS研究中，根据医生发起的研究用新药申请（IND），被开发用于治疗急性应激反应和急性应激障碍。

Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic in Phase 2 development designed to treat cocaine intoxication that has FDA Breakthrough Therapy designation, and its development is supported by a grant from the National Institute on Drug Abuse. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is an Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases.

Tonix的中枢神经系统（CNS）产品组合包括TNX-1300（可卡因酯酶），这是一种处于二期开发阶段的生物制品，旨在治疗可卡因中毒，并已获得FDA突破性疗法认定，其开发得到了国家药物滥用研究所的资助。Tonix的免疫学开发产品组合包括用于应对器官移植排斥、自身免疫和癌症的生物制品，其中包括TNX-1500，这是一种Fc修饰的人源化单克隆抗体，靶向CD40配体（CD40L或CD154），正在开发用于预防同种异体移植排斥和治疗自身免疫疾病。

TNX-1500 has completed a positive Phase I trial. Tonix’s infectious disease portfolio includes TNX-801, a vaccine in development for mpox and smallpox, as well as TNX-4200 for which Tonix has a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) fo.

TNX-1500 已完成了一项积极的 I 期试验。Tonix 的传染病产品组合包括 TNX-801，一种正在开发用于猴痘和天花的疫苗，以及 TNX-4200，Tonix 与美国国防部下属的国防威胁减少局 (DTRA) 签有合同。

®

®

SymTouch

触摸符号

®

®

(sumatriptan injection) 3 mg and Tosymra

（舒马普坦注射液）3毫克和Tosymra

®

®

(sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.

(sumatriptan鼻喷雾剂) 10毫克，用于治疗成人急性偏头痛，无论是否伴有先兆。

* Tonix’s product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication.

* Tonix的产品开发候选药物为研究性新药或生物制品；其疗效和安全性尚未确立，也未获批准用于任何适应症。

Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.

Zembrace SymTouch 和 Tosymra 是 Tonix Medicines 的注册商标。所有其他标志均为其各自所有者的财产。

This press release and further information about Tonix can be found at

本新闻稿和有关Tonix的更多信息可在此处找到：

www.tonixpharma.com

www.tonixpharma.com

.

。

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Noyce RS, et al. Viruses. 2023 Jan 26;15(2):356. Doi: 10.3390/v15020356. PMID: 36851570; PMCID: PMC9965234

诺伊斯 RS 等。病毒。2023年1月26日；15(2):356。doi: 10.3390/v15020356。PMID: 36851570；PMCID: PMC9965234

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WHO Press Release August 14, 2024. “WHO Director-General declares mpox outbrfeak a public health emergency of international concern”. URL:

世界卫生组织新闻稿 2024年8月14日。 “世卫组织总干事宣布猴痘疫情为国际关注的突发公共卫生事件”。 网址：

www.who.int/news/item/14-08-2024-who-director-general-declares-mpox-outbreak-a-public-health-emergency-of-international-concern

www.who.int/news/item/2024年8月14日-世卫组织总干事宣布猴痘疫情为国际关注的突发公共卫生事件

(accessed 8-15-24)

（引用日期：24年8月15日）

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McQuiston JH, et al.

麦克奎斯顿 JH，等。

U.S. Preparedness and Response to Increasing Clade I Mpox Cases in the Democratic Republic of

美国对刚果民主共和国日益增加的进化枝I型猴痘病例的准备和应对措施

the Congo

刚果

. 2024, MMWR Morbi Mortal Wkly Rep: United States. p. 435-440

2024年，MMWR疾病与死亡率周报：美国，第435-440页

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https://www.cdc.gov/mpox/situation-summary/

https://www.cdc.gov/mpox/situation-summary/

Forward Looking Statements

前瞻性声明

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others.

本新闻稿中的某些陈述属于1995年《私人证券诉讼改革法案》定义的前瞻性陈述。这些陈述可能通过使用诸如“预期”、“相信”、“预测”、“估计”、“预计”和“打算”等前瞻性词语来识别。

These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition.

这些前瞻性陈述基于Tonix的当前预期，实际结果可能会有重大差异。有许多因素可能导致实际事件与这些前瞻性陈述所表明的情况有重大不同。这些因素包括但不限于：未能获得FDA核准或批准以及不符合FDA法规的风险；未能成功推广我们任何产品的风险；我们的产品候选物临床开发的时间和进展相关风险；我们对额外融资的需求；专利保护和诉讼的不确定性；政府或第三方支付方报销的不确定性；研发力度有限及对第三方的依赖；以及激烈的竞争。

As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, and periodic reports filed with the SEC on or after the date thereof.

与任何正在开发的药物一样，新产品的开发、监管审批和商业化过程中存在重大风险。Tonix 不承担更新或修改任何前瞻性声明的义务。投资者应阅读公司于2024年4月1日向美国证券交易委员会（“SEC”）提交的截至2023年12月31日年度的Form 10-K年报中列出的风险因素，以及在该日期或之后向SEC提交的定期报告。

All of Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set fort.

所有前瞻性声明均受所有此类风险因素和其他警示声明的明确限定。所提供的信息。

Investor Contact

投资者联系

Jessica Morris

杰西卡·莫里斯

Tonix Pharmaceuticals

托尼克斯制药公司

investor.relations@tonixpharma.com

投资者关系@tonixpharma.com

(862) 799-8599

(862) 799-8599

Peter Vozzo

彼得·沃佐

ICR Healthcare

ICR医疗保健

peter.vozzo@icrhealthcare.com

彼得·沃佐@icrhealthcare.com

(443) 213-0505

(443) 213-0505

Media Contact

媒体联系人

Ray Jordan

雷·乔丹

Putnam Insights

普特南洞察

ray@putnaminsights.com

ray@putnaminsights.com

(949) 245-5432

(949) 245-5432

Indication and Usage

适应症和用法

Zembrace

泽姆布雷斯

®

®

SymTouch

触控符号

®

®

(sumatriptan succinate) injection (Zembrace) and Tosymra

（琥珀酸舒马普坦）注射液（Zembrace）和Tosymra

®

®

(sumatriptan) nasal spray are prescription medicines used to treat acute migraine headaches with or without aura in adults who have been diagnosed with migraine.

(sumatriptan) 鼻喷雾剂是一种处方药，用于治疗被诊断为偏头痛的成人急性偏头痛（无论有无先兆）。

Zembrace and Tosymra are not used to prevent migraines. It is not known if Zembrace or Tosymra are safe and effective in children under 18 years of age.

Zembrace 和 Tosymra 不用于预防偏头痛。目前尚不清楚 Zembrace 或 Tosymra 在 18 岁以下儿童中是否安全有效。

Important Safety Information

重要安全信息

Zembrace and Tosymra can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop use and get emergency help if you have any signs of a heart attack:

Zembrace 和 Tosymra 可能导致严重的副作用，包括心脏病发作和其他心脏问题，这些问题可能会导致死亡。如果出现任何心脏病发作的迹象，请停止使用并寻求紧急帮助：

Zembrace and Tosymra are not for people with risk factors for heart disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam shows no problem.

Zembrace 和 Tosymra 不适用于有心脏病风险因素（高血压或高胆固醇、吸烟、超重、糖尿病、心脏病家族史）的人，除非心脏检查显示没有问题。

Do not use Zembrace or Tosymra if you have:

如果您有以下情况，请勿使用Zembrace或Tosymra：

Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements.

告诉您的医生您的所有健康状况以及您正在服用的所有药物，包括维生素和补充剂。

Zembrace and Tosymra can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert.

Zembrace 和 Tosymra 可能导致头晕、虚弱或嗜睡。如果是这样，请勿驾驶汽车、操作机器或做任何需要保持警觉的事情。

Zembrace and Tosymra may cause serious side effects including:

Zembrace 和 Tosymra 可能导致严重的副作用，包括：

The most common side effects of Zembrace and Tosymra include: pain and redness at injection site (Zembrace only); tingling or numbness in your fingers or toes; dizziness; warm, hot, burning feeling to your face (flushing); discomfort or stiffness in your neck; feeling weak, drowsy, or tired; application site (nasal) reactions (Tosymra only) and throat irritation (Tosymra only)..

Zembrace 和 Tosymra 最常见的副作用包括：注射部位疼痛和发红（仅 Zembrace）；手指或脚趾刺痛或麻木；头晕；面部发热、灼烧感（潮红）；颈部不适或僵硬；感到虚弱、嗜睡或疲倦；应用部位（鼻腔）反应（仅 Tosymra）以及喉咙刺激（仅 Tosymra）。

Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Zembrace and Tosymra. For more information, ask your provider.

如果您有任何困扰您的或不消失的副作用，请告诉您的医生。这些并非Zembrace和Tosymra的所有可能副作用。欲了解更多信息，请咨询您的医生。

This is the most important information to know about Zembrace and Tosymra but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit https://www.tonixpharma.com or call 1-888-869-7633.

这是关于Zembrace和Tosymra最重要的信息，但并不全面。欲了解更多信息，请咨询您的医生并阅读患者信息和使用说明。您还可以访问https://www.tonixpharma.com 或拨打1-888-869-7633。

You are encouraged to report adverse effects of prescription drugs to the FDA. Visit

我们鼓励您向 FDA 报告处方药的不良反应。请访问

www.fda.gov/medwatch

www.fda.gov/medwatch

, or call 1-800-FDA-1088.

，或者拨打1-800-FDA-1088。

Released March 10, 2025

发布于2025年3月10日