Ms. Fogarty has served at Tonix since 2016, most recently as Executive Vice President, Product Development

福格蒂女士自2016年以来一直在Tonix任职，最近一次担任产品开发执行副总裁

Tonix is Preparing for Potential Launch of TNX-102 SL for the management of fibromyalgia with U.S. FDA PDUFA goal date of August 15, 2025

Tonix正在准备推出用于治疗纤维肌痛的TNX-102 SL，美国FDA PDUFA的目标日期为2025年8月15日

CHATHAM, N.J., Feb. 04, 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 the promotion of Siobhan Fogarty to Chief Technical Officer (CTO), effective immediately.

新泽西州查塔姆，2025年2月4日（环球通讯社）--Tonix Pharmaceuticals Holding Corp.（纳斯达克代码：TNXP）（Tonix或该公司），一家拥有上市产品和开发候选人渠道的完全整合的生物制药公司，今天宣布将Siobhan Fogarty晋升为首席技术官（CTO），立即生效。

Ms. Fogarty joined Tonix in 2016 and previously served as Executive Vice President of Product Development. Ms. Fogarty has over 25 years of experience in pharmaceutical and biotech product development, manufacturing and quality, for both small and large molecules, at notable pharmaceutical and biotech companies..

福格蒂女士于2016年加入Tonix，此前担任产品开发执行副总裁。福格蒂女士在著名的制药和生物技术公司拥有超过25年的制药和生物技术产品开发、制造和质量经验，无论是小分子还是大分子。。

In December, Tonix announced that the U.S. Food and Drug Administration (FDA) assigned a Prescription Drug User Fee Act (PDUFA) goal date of August 15, 2025, for a decision on marketing authorization for TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 5.6 mg for the management of fibromyalgia. TNX-102 SL is a non-opioid, centrally-acting analgesic.

12月，Tonix宣布，美国食品和药物管理局（FDA）将处方药用户费用法案（PDUFA）的目标日期定为2025年8月15日，以决定TNX-102 SL（盐酸环苯扎林舌下片剂）5.6 mg用于治疗纤维肌痛的上市授权。TNX-102 SL是一种非阿片类中枢镇痛药。

Fibromyalgia is a common chronic pain condition that affects mostly women..

纤维肌痛是一种常见的慢性疼痛，主要影响女性。。

“Siobhan is an invaluable member of our team and an outstanding leader who has contributed in many ways to our success since she joined in 2016, and we are excited that she is executing at a higher level in her new role as our first CTO,” said Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals.

。

“Her energy, insights and organizational abilities will be welcome as we enter into a landmark time for the Company with the upcoming PDUFA goal date of August 15, 2025, for TNX-102 SL for the management of fibromyalgia. In addition to her stewardship of TNX-102 SL, Siobhan has played key roles advancing our pipeline of small molecule, biologics and live-virus vaccines.”.

“随着PDUFA即将于2025年8月15日实现TNX-102 SL治疗纤维肌痛的目标，她的精力，见解和组织能力将受到欢迎。除了她对TNX-102 SL的管理之外，Siobhan在推进我们的小分子，生物制剂和活病毒疫苗管道方面发挥了关键作用。”。

Ms. Fogarty started her career with Elan Corporation as a formulation scientist where she gained experience in several different areas of drug delivery, including solid, liquids, IV, and transdermal formulations. At Elan, she took products from concept to commercial manufacture in both Ireland and the U.S.

福格蒂女士在Elan Corporation开始了她的职业生涯，她是一名配方科学家，在那里她在药物输送的几个不同领域获得了经验，包括固体，液体，IV和透皮制剂。在Elan，她在爱尔兰和美国将产品从概念转变为商业制造。

Ms. Fogarty moved to Glaxo SmithKline, London, as a manufacturing strategist after the merger of Glaxo and SmithKline Beecham. Returning to product development, Ms. Fogarty established European product development sites for Fuisz Technologies and Biovail Corporation, leading multi-disciplinary teams for the development of products from early conceptual/preclinical development, through the various clinical phases and transferring to U.S./Canadian manufacturing sites during registration for commercialization.

葛兰素史克和史克比查姆合并后，福格蒂女士搬到伦敦的葛兰素史克担任制造业战略家。回到产品开发领域，福格蒂女士为Fuisz Technologies和Biovail Corporation建立了欧洲产品开发网站，领导多学科团队开发产品，从早期概念/临床前开发到各个临床阶段，并在注册商业化期间转移到美国/加拿大制造基地。

Subsequently, Ms. Fogarty started a consultancy firm, eMSc, that advised pharmaceutical and biotech companies in product development and implementation of a phased approach to quality.   Ms. Fogarty obtained her masters in Pharmaceutical Sciences at Trinity College, Dublin, and is a European Union Qualified Person.

随后，福格蒂女士创办了一家咨询公司eMSc，为制药和生物技术公司的产品开发和分阶段质量管理提供咨询。福格蒂女士在都柏林三一学院获得药学硕士学位，是欧盟合格人士。

Her primary degree is in Industrial Chemistry from the University of Limerick where she interned at Pfizer..

她的主要学位是利默里克大学的工业化学，她在辉瑞公司实习。。

“I am grateful for the incredible eight years I have already enjoyed working at Tonix and look forward to the challenges and opportunities of my new role,” said Ms. Fogarty. “Tonix is entering a momentous time, and it is an honor to assume these new responsibilities as part of this extraordinary team.”.

福格蒂女士说：“我很感激在托尼工作了令人难以置信的八年，并期待着我新角色的挑战和机遇。”。“托尼正在进入一个重要的时期，作为这个非凡团队的一部分，承担这些新的责任是一种荣誉。”。

Tonix Pharmaceuticals Holding Corp.

东京制药控股公司。

*

*

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是一家全面整合的生物制药公司，专注于改变疼痛管理疗法和应对公共卫生挑战的疫苗。。Tonix的首要任务是推进TNX-102 SL，这是一种治疗纤维肌痛的候选产品，根据两项具有统计学意义的纤维肌痛治疗3期研究提交了NDA，并为其指定了2025年8月15日的PDUFA（处方药用户费用法案）目标日期，以决定上市授权。

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).

FDA还批准TNX-102 SL用于治疗纤维肌痛的快速通道。在美国国防部（DoD）资助的OASIS研究中，北卡罗莱纳大学（University of North Carolina）的医师发起的IND也正在开发TNX-102 SL，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的中枢神经系统产品组合包括TNX-1300（可卡因酯酶），这是一种用于治疗可卡因中毒的生物制剂，已被FDA授予突破性治疗称号，其开发得到了美国国家药物滥用研究所的资助。Tonix的免疫学开发组合包括用于解决器官移植排斥反应，自身免疫和癌症的生物制剂，包括TNX-1500，它是一种针对CD40配体（CD40L或CD154）的Fc修饰的人源化单克隆抗体，正在开发用于预防同种异体移植物排斥反应和治疗自身免疫性疾病。

Tonix also has product candidates in development in the area of infectious disease, including a vaccine for mpox, TNX-801. Tonix recently announced a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to $34 million over five years to devel.

Tonix还在传染病领域开发候选产品，包括mpox疫苗TNX-801。Tonix最近宣布与美国国防部国防威胁减少局（DTRA）签订合同，在五年内提供3400万美元用于开发。

®

®

SymTouch

SymTouch

®

®

(sumatriptan injection) 3 mg and Tosymra

®

®

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

（舒马曲坦鼻喷雾剂）10毫克，用于治疗成人有或没有先兆的急性偏头痛。

* 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的产品开发候选人是研究性新药或生物制剂；。

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。所有其他标记均为其各自所有者的财产。

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

有关Tonix的新闻稿和更多信息，请访问

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.

根据1995年《私人证券诉讼改革法案》，本新闻稿中的某些声明具有前瞻性。这些陈述可以通过使用前瞻性词语来识别，例如“预期”、“相信”、“预测”、“估计”、“预期”和“打算”等。

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.

这些前瞻性声明是基于Tonix目前的预期，实际结果可能会有很大差异。有许多因素可能导致实际事件与此类前瞻性声明所示的事件存在重大差异。；与未能成功销售我们的任何产品有关的风险；与我们候选产品临床开发的时间和进度相关的风险；我们需要额外的融资；专利保护和诉讼的不确定性；政府或第三方付款人报销的不确定性；有限的研发工作和对第三方的依赖；和实质性竞争。

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，监管批准和商业化都存在重大风险。Tonix不承担更新或修订任何前瞻性声明的义务。投资者应阅读2024年4月1日提交给美国证券交易委员会（“SEC”）的截至2023年12月31日的年度报表10-K中列出的风险因素，以及在该日期或之后提交给SEC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.

所有此类风险因素和其他警示性声明明确限定了Tonix的所有前瞻性声明。信息集堡垒。

Investor Contact

投资者联系人

Jessica Morris

杰西卡·莫里斯

Tonix Pharmaceuticals

Tonix 制药

investor.relations@tonixpharma.com

investor.relations@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

peter.vozzo@icrhealthcare.com

(443) 213-0505

(443) 213-0505

Media Contact

媒体联系人

Ray Jordan

雷·乔丹

Putnam Insights

Putnam Insights公司

ray@putnaminsights.com

ray@putnaminsights.com

(949) 245-5432

(949) 245-5432

Indication and Usage

适应症和用法

Zembrace

Zembrace 的

®

®

SymTouch

SymTouch

®

®

(sumatriptan succinate) injection (Zembrace) and Tosymra

（琥珀酸舒马曲坦）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.

（舒马曲普坦）鼻喷雾剂是一种处方药，用于治疗被诊断患有偏头痛的成年人中有或没有先兆的急性偏头痛。

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对18岁以下儿童是否安全有效。

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会引起严重的副作用，包括心脏病发作和其他心脏问题，可能导致死亡。如果您有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不适合有心脏病危险因素（高血压或胆固醇、吸烟、超重、糖尿病、心脏病家族史）的人，除非心脏检查没有问题。

Do not use Zembrace or Tosymra if you have:

如果您有以下情况，请不要使用Zembrace或Tosymra：

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

告诉你的医生你的所有医疗状况和服用的药物，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会导致头晕、虚弱或嗜睡。如果是这样，不要开车，不要使用机器，也不要在需要警惕的地方做任何事情。

Zembrace and Tosymra may cause serious side effects including:

Zembrace和Tosymra可能会引起严重的副作用，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；脸上有温暖、炎热、灼热的感觉（潮红）；颈部不适或僵硬；感到虚弱、昏昏欲睡或疲倦；应用部位（鼻腔）反应（仅Tosymra）和喉咙刺激（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.

如果你有任何副作用困扰你或没有消失，请告诉你的医生。这些并不是Zembrace和Tosymra可能产生的所有副作用。有关更多信息，请咨询您的提供商。

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.

这是了解Zembrace和Tosymra最重要的信息，但并不全面。有关更多信息，请与您的提供者联系，并阅读患者信息和使用说明。https://www.tonixpharma.com或致电1-888-869-7633。

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

鼓励您向FDA报告处方药的不良反应。访问

www.fda.gov/medwatch

政府/医疗观察

, or call 1-800-FDA-1088.

，或致电1-800-FDA-1088。

Released February 4, 2025

2025年2月4日发布