CHATHAM, N.J., April 01, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a biopharmaceutical company with a portfolio of marketed products and a pipeline of development candidates, today announced the launch of TONIX ONE™, a fully-integrated digital platform designed to help patients better understand and manage their migraine condition.

新泽西州查塔姆，2025年4月1日（环球新闻社）——Tonix制药控股公司（纳斯达克股票代码：TNXP），一家拥有上市产品组合和开发候选药物管线的生物制药公司，今天宣布推出TONIX ONE™，这是一个完全集成的数字平台，旨在帮助患者更好地理解和管理他们的偏头痛状况。

Through a series of strategic partnerships with UpScript Telemedicine, ProModRx, Blink Health and a leading mobile application specializing in disease tracking, reporting and symptom management, Tonix is streamlining the migraine patient journey into a unified digital platform. Please visit .

通过与UpScript远程医疗、ProModRx、Blink Health以及一家专注于疾病追踪、报告和症状管理的领先移动应用达成一系列战略合作，Tonix正在将偏头痛患者的治疗过程整合到一个统一的数字平台中。请访问 。

www.tonixone.com

www.tonixone.com

for details.

详情请见。

“We developed TONIX ONE to leverage innovation and deliver a full-service digital solution that seamlessly guides patients from their migraine diary app to prescription fulfillment within hours. Our goal is not only to educate and empower patients seeking better treatment options but also to remove the barriers to care that many individuals living with migraines face,” said Scott Szymanski, Vice President of Sales and Marketing, Migraine, of Tonix Pharmaceuticals..

“我们开发了TONIX ONE，利用创新技术提供全方位的数字解决方案，无缝引导患者从偏头痛日记应用到数小时内完成处方配药。我们的目标不仅是教育和赋予寻求更好治疗选择的患者权力，还要消除许多偏头痛患者面临的护理障碍，”Tonix Pharmaceuticals偏头痛销售与营销副总裁Scott Szymanski表示。

TONIX ONE provides an intuitive, comprehensive journey for patients by offering educational resources about migraine and the limitations of oral medications which can sometimes lead to delayed or ineffective symptom relief. The platform also connects patients directly to migraine specialists via telehealth services and e-prescription requests, simplifying and accelerating access to treatment..

TONIX ONE 为患者提供了一个直观且全面的旅程，通过提供关于偏头痛及其口服药物局限性的教育资源，这些局限性有时会导致症状缓解延迟或无效。该平台还通过远程医疗服务和电子处方请求直接将患者与偏头痛专家联系起来，简化并加速了治疗的获取过程。

“With the launch of TONIX ONE, we are further strengthening Tonix Pharmaceuticals’ position as a leader in innovation, addressing barriers and inefficiencies that stand between patients and the life-changing medications they need,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals.

“随着TONIX ONE的推出，我们正在进一步巩固Tonix Pharmaceuticals作为创新领导者的地位，解决患者与他们所需改变生活的药物之间的障碍和低效问题，”Tonix Pharmaceuticals首席执行官Seth Lederman博士说道。

“By offering a fully-integrated digital platform that streamlines disease state education, prescription acquisition, and fulfillment, we are enhancing access for patients while creating value across our existing portfolio, pipeline, and future business development opportunities.”.

“通过提供一个完全集成的数字平台，简化疾病状态教育、处方获取和履行流程，我们正在增强患者获取途径，同时为现有的产品组合、研发管线和未来的业务发展机会创造价值。”

Gpmigraine.com

Gpmigraine.com

provides patients with valuable insights into migraine management by addressing the challenges associated with oral medications due to gastroparesis. The platform helps patients explore alternative treatments and empowers them to make informed decisions about their care.

通过解决因胃轻瘫导致的口服药物挑战，为患者提供有关偏头痛管理的宝贵见解。该平台帮助患者探索替代疗法，并赋予他们对自身护理做出明智决策的能力。

ProModRx

ProModRx

provides patients with a digital solution, dRx Request, to request an e-prescription from their established migraine clinician.

为患者提供了一种数字解决方案 dRx Request，以便向其指定的偏头痛医生请求电子处方。

UpScript Health

UpScript Health

is the leading telemedicine provider in the U.S. For patients who do not have an established migraine clinician or would rather use telemedicine, UpScript provides patients real-time access to 100’s of expert clinicians.

是美国领先的远程医疗提供商。对于没有固定偏头痛医生或更愿意使用远程医疗的患者，UpScript 为患者提供实时访问数百名专家的机会。

Blink Health

闪烁健康

is revolutionizing the pharmacy experience, using digital cutting-edge technology to dramatically improve patient access for branded medications.

正在通过使用尖端数字技术彻底改变药房体验，大幅改善患者对品牌药物的获取途径。

A leading mobile application

一款领先的移动应用程序

operated by a third party, and accessible on the TONIX ONE platform, designed to empower patients suffering from headaches and migraines through data-driven insights, enabling tracking, reporting, and self-management. By providing valuable health data, the platform helps accelerate diagnosis and optimize treatment options, ultimately enhancing the quality of life for people living with migraine symptoms, which in turn can accelerate diagnosis and fine-tune treatment options..

由第三方运营，并在TONIX ONE平台上可用，旨在通过数据驱动的洞察力帮助头痛和偏头痛患者，实现跟踪、报告和自我管理。通过提供宝贵的健康数据，该平台有助于加速诊断并优化治疗方案，最终提高偏头痛症状患者的生活质量，从而进一步加快诊断并微调治疗选择。

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《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快速通道资格，用于纤维肌痛的管理。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 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的突破性疗法认定，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 also has product candidates in development in 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 develop TNX-4200,.

Tonix 公司还有多个处于开发阶段的候选产品，涉及传染病领域，其中包括一款针对 mpox（猴痘）的疫苗 TNX-801。Tonix 近期宣布与美国国防部下属的国防威胁减少局 (DTRA) 签订了一份合同，将在五年内获得高达 3400 万美元的资金，用于开发 TNX-4200。

®

®

SymTouch

触控符号

®

®

(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 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，尚未获准用于任何适应症。

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

.

。

Please visit

请访问

www.tonixone.com

www.tonixone.com

for Tonix’s fully-integrated digital platform designed to help patients better understand and manage their migraine condition.

适用于Tonix完全集成的数字平台，该平台旨在帮助患者更好地理解和管理他们的偏头痛状况。

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“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示的情况有重大差异。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；我们产品候选物临床开发的时机和进展相关的风险；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, 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日的年度报告表格10-K中的风险因素，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此类风险因素和其他警示声明的明确限定。所提供的信息。

Media Contact

媒体联系人

Lisa DeScenza

丽莎·德森扎

LaVoieHealthScience

LaVoie健康科学

ldescenza@lavoiehealthscience.com

ldescenza@lavoiehealthscience.com

(978) 395-5970

(978) 395-5970

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

Indication and Usage

适应症和用法

Zembrace

泽姆布雷斯

®

®

SymTouch

对称触控

®

®

(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，用于治疗已被诊断为偏头痛的成人的急性偏头痛（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 Zembrace）；手指或脚趾刺痛或麻木；头晕；面部温暖、发热、灼烧感（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.

如果出现任何困扰您或持续不退的副作用，请告知您的医生。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。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 April 1, 2025

发布于2025年4月1日