CHATHAM, N.J., June 10, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biotechnology company with marketed products and a pipeline of development candidates, today announced that Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals, will present at the 2025 BIO International Convention, being held June 16-19, 2025, in Boston, Mass.

新泽西州查塔姆，2025年6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技术公司，今日宣布，Tonix制药首席执行官Seth Lederman博士将在2025年6月16日至19日于马萨诸塞州波士顿举行的2025年国际生物技术大会（BIO International Convention）上发表演讲。

The Company’s presentation will take place on Monday, June 16, at 5:00 p.m. in Room 153B at the Boston Convention & Exhibition Center..

公司的演讲将于6月16日星期一下午5点在波士顿会议展览中心153B室举行。

To schedule a meeting with the Company’s management at the convention, please submit a meeting request through the BIO One-on-One Partnering™ system or contact

要在大会期间安排与公司管理层的会议，请通过BIO一对一合作™系统提交会议请求或联系

brandon.weiner@icrhealthcare.com

布兰登·韦纳@icrhealthcare.com

.

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Tonix Pharmaceuticals Holding Corp.

Tonix制药控股公司

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*

Tonix is a fully integrated biotech 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技术公司，专注于转化疼痛管理疗法和应对公共卫生挑战的疫苗。Tonix的研发组合侧重于中枢神经系统（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了新药申请（NDA），并被分配了2025年8月15日作为《处方药使用者费用法案》（PDUFA）的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性新药申请（IND），被开发用于治疗急性应激反应和急性应激障碍。

Tonix’s 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的免疫学开发组合包括用于解决器官移植排斥、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。

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) for up to $34 million over five years. TNX-4200 is a small molecule broad-spectrum antiviral agent targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments.

Tonix的传染病产品组合包括TNX-801，一种正在研发中的猴痘和天花疫苗，以及TNX-4200，Tonix与美国国防部国防威胁减少局（DTRA）签订了高达3400万美元、为期五年的合同。TNX-4200是一种小分子广谱抗病毒药物，靶向CD45，用于预防或治疗感染，以提高军事人员在生物威胁环境中的医疗准备能力。

Tonix owns and operates a state-of-the art infectious disease research facilit.

Tonix 拥有并经营着一个最先进的传染病研究设施。

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®

SymTouch

触摸符号

®

®

(sumatriptan injection) 3 mg and Tosymra

(sumatriptan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.

（舒马曲普坦鼻喷雾剂）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

.

。

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》所指的前瞻性声明。这些声明可以通过使用诸如“预期”、“相信”、“预测”、“估计”、“预计”和“意图”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的批准或许可及违反FDA法规的风险；未能成功营销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的风险；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；研发能力有限且依赖第三方；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, 2024, as filed with the Securities and Exchange Commission (the “SEC”) on March 18, 2025, 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2025年3月18日向证券交易委员会（“SEC”）提交的截至2024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 for.

所有前瞻性声明均受所有风险因素和其他警示声明的明确限定。所提供的信息。

Investor Contact

投资者联系方式

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

对称触控

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(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.

（舒马普坦）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，无论是否伴有先兆。

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。如果出现心脏病发作的任何症状，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、乏力或嗜睡。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（仅限 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；感觉虚弱、嗜睡或疲倦；应用部位（鼻腔）反应（仅限 Tosymra）以及喉咙刺激（仅限 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.

如果出现任何困扰您或持续不消退的副作用，请告知您的医生。Zembrace 和 Tosymra 可能还有其他副作用。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。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 June 10, 2025

发布于2025年6月10日