Investigator-initiated Phase 2 trial to evaluate TNX-102 SL’s potential to reduce severity of acute stress reaction (ASR) and frequency of acute stress disorder (ASD)

研究者发起的II期试验，评估TNX-102 SL减轻急性应激反应（ASR）严重程度和急性应激障碍（ASD）发生频率的潜力。

Trial is sponsored by the University of North Carolina (UNC) and supported by a grant from the U.S. Department of Defense

试验由北卡罗来纳大学（UNC）主办，并受到美国国防部的资助支持。

Topline results from the trial are expected in the second half of 2026

该试验的初步结果预计将在2026年下半年公布。

CHATHAM, N.J., May 21, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a fully-integrated biotechnology company with marketed products and a pipeline of development candidates, today announced the first patient has been dosed in the Phase 2, investigator-initiated OASIS trial to evaluate TNX-102 SL in reducing the severity of acute stress reaction (ASR) and the frequency of acute stress disorder (ASD).

新泽西州查塔姆，2025年5月21日（环球新闻社）——Tonix Pharmaceuticals Holding Corp.（纳斯达克股票代码：TNXP），一家拥有上市产品和开发候选药物的全集成生物技术公司，今日宣布，在评估TNX-102 SL减轻急性应激反应（ASR）严重程度及急性应激障碍（ASD）发生频率的二期研究者发起的OASIS试验中，首例患者已开始接受给药。

The trial is sponsored by the University of North Carolina (UNC) Institute for Trauma Recovery and supported by a $3 million grant from the U.S. Department of Defense (DoD)..

该试验由北卡罗来纳大学（UNC）创伤恢复研究所赞助，并得到美国国防部（DoD）300万美元的资助。

“TNX-102 SL has been shown to improve sleep quality in PTSD, and previous trials of TNX-102 SL suggested activity on sleep and stress-related symptoms in the first several weeks of treatment,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Addressing sleep disturbances is crucial in managing ASR, as poor sleep can exacerbate other symptoms and hinder recovery.

“TNX-102 SL 已被证明可以改善 PTSD 患者的睡眠质量，之前对 TNX-102 SL 的试验表明，在治疗的最初几周内，该药物对睡眠和与压力相关的症状有作用，”Tonix Pharmaceuticals 首席执行官 Seth Lederman 医学博士说道。“解决睡眠障碍对于管理 ASR 至关重要，因为糟糕的睡眠可能加重其他症状并阻碍康复。”

There is a significant unmet need for treating ASR after traumatic events, such as civilian motor vehicle collisions or warfighter experiences in forward bases or in theater. We are encouraged by the support of TNX-102 SL’s prior data improving PTSD symptomatology in the first several weeks of treatment, which may be crucial to reducing ASR symptoms and their sequalae.

在创伤事件（如平民机动车碰撞或战士在前线基地或战场的经历）后，治疗ASR存在显著的未满足需求。我们对TNX-102 SL之前的数据支持感到鼓舞，这些数据表明在治疗的前几周内其改善了PTSD症状，这对减轻ASR症状及其后遗症可能至关重要。

We look forward to topline results in the second half of 2026.”.

我们期待着在2026年下半年获得顶线结果。

The Optimizing Acute Stress Reaction Interventions with TNX-102 SL (OASIS) trial will examine the safety and efficacy of TNX-102 SL to reduce adverse posttraumatic neuropsychiatric sequelae among patients presenting to the emergency department (ED) after a motor vehicle collision (MVC). The trial plans to enroll approximately 180 MVC-trauma survivors at ED study sites around the U.S.

优化急性应激反应干预与TNX-102 SL（OASIS）试验将评估TNX-102 SL在减少机动车碰撞（MVC）后前往急诊科（ED）就诊患者不良创伤后神经精神后遗症方面的安全性和有效性。该试验计划在美国各地的急诊科研究站点招募大约180名MVC创伤幸存者。

Participants will be randomized in the ED to receive a two-week course of either TNX-102 SL 5.6 mg or placebo..

参与者将在急诊科被随机分配接受为期两周的TNX-102 SL 5.6毫克或安慰剂疗程。

The OASIS trial will build upon a foundation of knowledge and infrastructure developed through the UNC-led, $40 million AURORA initiative. AURORA is a major national research initiative to improve the understanding, prevention and recovery of individuals who experience a traumatic event. AURORA is supported by funding from the National Institutes of Health (NIH), leading brain health nonprofit One Mind, private foundations, and partnerships with leading tech companies, such as Mindstrong Health and Verily Life Sciences, the healthcare arm of Alphabet, the parent company of Google..

OASIS 试验将在由北卡罗来纳大学领导的、耗资 4000 万美元的 AURORA 计划所建立的知识和基础设施基础上展开。AURORA 是一项重要的全国性研究计划，旨在加强对经历创伤事件的个体的理解、预防和康复。AURORA 获得了来自美国国立卫生研究院 (NIH)、领先的脑健康非营利组织 One Mind、私人基金会以及与领先科技公司的合作支持，例如 Mindstrong Health 和 Verily Life Sciences（Alphabet 旗下谷歌的母公司旗下的医疗保健部门）。

Acute and chronic stress disorders can affect both civilian and military populations. According to the National Center for PTSD, in the U.S. about 60% of men and 50% of women experience at least one trauma in their lives In the U.S. alone, one-third of ED visits (40-50 million patients per year) involve evaluation after trauma exposures, and in a 2014 study involving 3,157 US veterans, 87% reported exposure to at least one potentially traumatic event during their service.

急性应激障碍和慢性应激障碍可能影响平民和军人。根据美国国家创伤后应激障碍中心的数据，在美国，约60%的男性和50%的女性在其一生中至少经历过一次创伤。仅在美国，每年三分之一的急诊就诊（4000万至5000万患者）涉及创伤暴露后的评估。在2014年一项针对3157名美国退伍军人的研究中，87%的人报告在服役期间至少接触过一次潜在的创伤事件。

Moreover, as many as 500,000 U.S. troops who served in wars between 2001 and 2015 were diagnosed with PTSD. Currently, no medication is available in the immediate aftermath of traumatic events to treat the initial reaction and support long term health via a post-trauma clinical trajectory that prevents development or worsening of ASD, thereby also preventing PTSD..

此外，多达50万名在2001年至2015年间参与战争的美军士兵被诊断出患有创伤后应激障碍（PTSD）。目前，在创伤事件发生后的立即阶段，尚无药物可用于治疗初始反应，并通过预防急性应激障碍（ASD）的发展或恶化来支持长期健康，从而也预防PTSD的发生。

For more information, see ClinicalTrials.gov Identifier:

有关更多信息，请参阅 ClinicalTrials.gov 标识符：

NCT06636786

NCT06636786

About TNX-102 SL

关于TNX-102 SL

TNX-102 SL is a centrally acting, non-opioid investigational drug, designed for chronic use. The tablet is a patented sublingual formulation of cyclobenzaprine hydrochloride developed for bedtime dosing for the management of fibromyalgia. Cyclobenzaprine potently binds and acts as an antagonist at four different post-synaptic neuroreceptor subtypes: serotonergic-5-HT2A, adrenergic-α1, histaminergic-H1, and muscarinic-M1-cholinergic receptors.

TNX-102 SL 是一种中枢作用、非阿片类的在研药物，设计用于慢性使用。该药片是一种获得专利的环苯扎林盐酸盐舌下含服制剂，专为睡前给药以管理纤维肌痛症而开发。环苯扎林能够强力结合并在四种不同的突触后神经受体亚型上充当拮抗剂：血清素能-5-HT2A、肾上腺素能-α1、组胺能-H1 和毒蕈碱-M1-胆碱能受体。

Together, these interactions are believed to target the non-restorative sleep characteristic of fibromyalgia identified by Professor Harvey Moldofsky in 1975. Cyclobenzaprine is not associated with risk of addiction or dependence. The TNX-102 SL tablet is based on a eutectic formulation of cyclobenzaprine HCl and mannitol that provides a stable product which dissolves rapidly and delivers cyclobenzaprine by the transmucosal route efficiently into the bloodstream.

这些相互作用共同被认为能够针对1975年由哈维·莫尔多夫斯基教授发现的纤维肌痛症患者的非恢复性睡眠特征。环苯扎林不会导致成瘾或依赖的风险。TNX-102 SL片剂基于环苯扎林盐酸盐和甘露醇的共熔配方，该配方提供了一种稳定的产品，能够快速溶解，并通过口腔黏膜途径高效地将环苯扎林输送到血液中。

The eutectic protects cyclobenzaprine HCl from interacting with the basifying agent that is also part of the formulation and required for efficient transmucosal absorption. Patents based on TNX-102 SL’s eutectic composition and its properties have issued in the U.S., E.U., Japan, China and many other jurisdictions around the world and provide market protection into 2034.

低共熔物保护盐酸环苯扎林不与配方中的碱化剂相互作用，该碱化剂是有效透粘膜吸收所必需的。基于TNX-102 SL低共熔组成的专利及其特性已在美国、欧盟、日本、中国和世界许多其他地区获得授权，并提供到2034年的市场保护。

The European Patent Office’s Opposition Division maintained Tonix’s European Patent EP 2 968 992 in unamended form after an Opposition was filed against it by a Sandoz subsidiary, Hexal AG. Hexal AG did not appeal that decision. The formulation of TNX-102 SL was designed specifically for sublingual administration and transmucosal absorption for bedtime dosing to target disturbed sleep, while reducing the risk of daytime somnolence.

欧洲专利局异议部在山德士子公司赫萨尔股份公司对Tonix的欧洲专利EP 2 968 992提出异议后，维持了该专利的原始形式。赫萨尔股份公司未对该决定提出上诉。TNX-102 SL的配方专门设计用于舌下给药和经黏膜吸收，以便在睡前服用，旨在改善睡眠障碍，同时降低日间嗜睡的风险。

Clinical pharmacokinetic studies indicated that relative to oral cyclobenza.

临床药代动力学研究表明，相对于口服环苯扎。

Tonix Pharmaceuticals Holding Corp.

托尼克斯制药控股公司

*

*

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是一家完全集成的生物技术公司，专注于开发疼痛管理和公共卫生挑战疫苗的变革性疗法。Tonix的研发组合主要集中于中枢神经系统（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。针对纤维肌痛管理的两项统计显著的III期研究已经完成，并据此提交了新药申请（NDA）。此外，FDA已为该药物设定PDUFA（处方药使用者费用法案）目标日期为2025年8月15日，以决定是否批准其上市销售。

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-801，一种正在开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）签订了为期五年、金额高达3400万美元的合同。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 拥有并经营着一家最先进的传染病研究机构。

* 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定，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》定义的前瞻性声明。这些声明可能通过使用诸如“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指的内容存在重大差异。这些因素包括但不限于：未能获得FDA核准或批准以及违反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；研发投入有限且依赖第三方；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日向美国证券交易委员会（“SEC”）提交的截至2024年12月31日的年度报告Form 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。信息如下。

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® SymTouch® (sumatriptan succinate) injection (Zembrace) and 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.

Zembrace® SymTouch®（琥珀酸舒马普坦）注射剂（Zembrace）和Tosymra®（舒马普坦）鼻喷雾剂是处方药，用于治疗已被诊断为偏头痛的成人急性偏头痛发作，无论是否有先兆。

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、家族心脏病史）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和您服用的药物，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 可能导致头晕、虚弱或嗜睡。如果出现这些症状，请勿驾驶车辆、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、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.

告诉您的医生您是否有任何困扰您或无法消退的副作用。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

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 May 21, 2025

发布于2025年5月21日