Tivic Health被选中于 5月 7日向战争技术观察计划部展示 Entolimod™作为辐射应对措施及其口服跨粘膜计划

SAN ANTONIO

圣安东尼奥

,

，

April 15, 2026

2026年4月15日

/PRNewswire/ -- Tivic Health Systems, Inc. (Nasdaq:

/PRNewswire/ -- Tivic Health Systems, Inc.（纳斯达克：

TIVC

TIVC

), a clinical-stage immunotherapeutics company, today announced it has been selected to present at the U.S. Department of War's Tech Watch program on May 7, 2026. The Tech Watch initiative identifies emerging technologies with high-value defense and dual-use applications.

），一家临床阶段的免疫治疗公司，今天宣布其已被选中于2026年5月7日在美国国防部的Tech Watch计划中进行展示。Tech Watch倡议旨在识别具有高价值防御和双重用途应用的新兴技术。

Tivic Health will present its Entolimod

Tivic Health 将展示其 Entolimod

™

™

TLR5 agonist lead drug candidate and its plans for an oral transmucosal delivery program for Entolimod

TLR5激动剂先导药物候选物及其关于Entolimod的口腔黏膜递送计划

™

™

— a delivery concept the Company believes has compelling and immediate relevance for both individual warfighter care and large-scale mass casualty response. The Company is currently in the process of engaging a specialized formulation development partner to advance this program.

——公司认为这一递送概念对单兵医疗护理和大规模伤亡响应都具有紧迫且直接的相关性。公司目前正在与一家专业配方开发合作伙伴接洽，以推进该计划。

'The geopolitical environment has fundamentally changed the calculus around medical countermeasure preparedness,' said Michael K. Handley, chief executive officer of Tivic Health Systems. 'The threats are no longer theoretical — governments around the world are actively reassessing their readiness, and the window to establish Entolimod™ as a cornerstone of national and allied defense stockpiles has never been more open.

“地缘政治环境已经从根本上改变了围绕医疗对策准备的考量，”Tivic Health Systems首席执行官迈克尔·K·汉德利表示。“威胁不再只是理论上的——世界各国政府正在积极重新评估其准备状态，而将Entolimod™确立为国家和盟国防御储备核心的时机从未如此开放。”

We believe this is the right technology, at exactly the right time.'.

我们相信，这正是正确的技术，且恰逢其时。

Entolimod™ is a selective Toll-like receptor 5 (TLR5) agonist that activates NF-κB signaling pathways to protect cells from radiation-induced damage across both bone marrow and gastrointestinal tissues simultaneously. This dual-system mechanism represents a meaningful advance over currently stockpiled ARS countermeasures, including Neupogen® (filgrastim), Neulasta® (pegfilgrastim), and Leukine® (sargramostim), which are designed to stimulate hematopoietic recovery but do not address the lethal damage caused to the gastrointestinal tract at higher radiation doses — a key determinant of survival that remains a significant unmet need..

Entolimod™ 是一种选择性 Toll 样受体 5 (TLR5) 激动剂，可激活 NF-κB 信号通路，同时保护骨髓和胃肠道组织免受辐射诱导的损伤。这种双系统机制相较于目前储备的急性辐射综合症 (ARS) 对策（如 Neupogen®（非格司亭）、Neulasta®（培非格司亭）和 Leukine®（沙格司亭））有了显著进步，后者旨在刺激造血恢复，但无法解决较高辐射剂量对胃肠道造成的致命损伤——这是决定生存率的关键因素，也是目前尚未满足的重要需求。

The Company is in early-stage exploration of an oral transmucosal delivery formulation intended to extend this radioprotection advantage by making Entolimod™ faster to administer, more stable, and accessible in scenarios where intravenous or injectable delivery is not practical. If successfully developed, an oral transmucosal formulation could be administered rapidly, without needles, and without the need for trained medical personnel — a critical advantage in combat environments and mass casualty events where speed of treatment and ease of administration can determine survival outcomes.

公司正在早期探索一种口服跨粘膜递送制剂，旨在通过使Entolimod™更快速施用、更稳定，并在静脉或注射给药不切实际的情况下可及，从而扩展这种放射防护优势。如果成功开发，口服跨粘膜制剂可以快速给药，无需针头，也无需训练有素的医务人员——这在战斗环境和大规模伤亡事件中是一个关键优势，因为治疗速度和给药便利性往往能决定生存结果。

The Company believes this delivery approach, if realized, could meaningfully expand access to life-saving countermeasures in scenarios where conventional medical infrastructure is unavailable, overwhelmed, or destroyed..

公司相信，如果这种交付方式得以实现，在传统医疗基础设施无法使用、不堪重负或被摧毁的情况下，它可以有意义地扩大获得救命对策的渠道。

'Our Entolimod™ platform was built to address the most urgent unmet needs in radiation medicine, and we believe an oral transmucosal approach, if successfully developed, would take that mission to the next level,' Mr. Handley continued. 'For the warfighter in the field and for first responders managing a mass casualty event, the ability to administer an effective radiation countermeasure quickly, simply, and without specialized equipment would be transformative.

汉德利先生继续说道：“我们的Entolimod™平台旨在解决放射医学中最紧迫的未满足需求，我们相信，如果成功开发出口腔黏膜途径，将会把这一使命提升到一个新的水平。对于在战场上的士兵和应对大规模伤亡事件的急救人员来说，能够快速、简单地施用一种有效的辐射对抗措施，并且无需使用特殊设备，这将是革命性的。”

We look forward to presenting this vision to the Department of War on May 7th and to advancing what we believe is a critical component of national preparedness.'.

我们期待着在5月7日向战争部展示这一愿景，并推进我们认为是国家准备工作的关键组成部分。

The Department of War has expressed encouraging interest in advancing discussions with Tivic Health regarding Entolimod™ and its potential applications for national defense preparedness.

战争部已表示出令人鼓舞的兴趣，愿与Tivic Health就Entolimod™及其在国防准备中的潜在应用推进讨论。

Strategic and Competitive Positioning

战略与竞争定位

Warfighter relevance:

作战人员相关性：

Addresses a critical unmet need in military radiation casualty care with a mechanism that protects both GI and hematopoietic tissues

满足了军事辐射伤亡护理中一个关键的未满足需求，其机制可同时保护胃肠道和造血组织。

Mass casualty potential:

大规模伤亡潜力：

Early-stage oral transmucosal delivery concept, if developed, could enable rapid treatment of large numbers of casualties without trained personnel or medical infrastructure

早期的口腔黏膜递送概念如果得以开发，可无需专业人员或医疗基础设施即可实现对大批伤员的快速治疗。

Differentiated mechanism:

差异化机制：

Dual GI and bone marrow protection versus currently stockpiled G-CSF therapies, which address only hematopoietic recovery

双效胃肠道和骨髓保护，相比当前储备的仅针对造血恢复的G-CSF疗法

Administration simplicity (target profile):

管理简便性（目标配置文件）：

No needle, no IV, no specialized equipment required — subject to successful formulation development

无需针头，无需静脉注射，无需专用设备——视配方开发是否成功而定。

Regulatory pathway:

监管途径：

Advancing toward BLA submission under the FDA's Animal Rule

根据FDA的动物规则，向BLA提交申请迈进

About Tivic Health Systems

关于Tivic健康系统

Tivic Health is developing biologics that activate innate immune pathways for cytoprotection and modulate immune responses in conditions driven by radiation, disease, and immune dysregulation. The company's lead candidate, Entolimod™ for acute radiation syndrome (ARS), has been extensively studied having demonstrated survival benefits and improved tissue recovery in animal models under the FDA's Animal Rule.

Tivic Health正在开发激活先天免疫途径以实现细胞保护并在由辐射、疾病和免疫失调引发的状况下调节免疫反应的生物制品。该公司的主要候选药物Entolimod™用于急性放射综合征（ARS），已在FDA的动物规则下通过动物模型进行了广泛研究，显示出生存益处和组织恢复的改善。

Entolimod™ is a novel Toll-like receptor 5 (TLR5) agonist that activates NF-κB signaling pathways to protect cells from damage and stimulate immune responses. Entolimod™ for ARS has received Fast Track and Orphan Drug designations from the U.S. Food and Drug Administration. Tivic is also advancing Entolasta™, a next-generation TLR5 agonist designed for potential broader therapeutic applications, including oncology supportive care.

Entolimod™ 是一种新型的Toll样受体5（TLR5）激动剂，可激活NF-κB信号通路以保护细胞免受损伤并刺激免疫反应。Entolimod™ 用于急性辐射综合征（ARS）已获得美国食品药品监督管理局（FDA）的快速通道和孤儿药资格认定。Tivic还在推进Entolasta™，这是一款下一代TLR5激动剂，设计用于潜在更广泛的治疗应用，包括肿瘤支持治疗。

Tivic's clinical pipeline includes potential treatments for neutropenia, which is most commonly caused by chemotherapy, and a state of T-cell dysfunction known as lymphocyte exhaustion. Tivic's wholly owned subsidiary, Velocity Bioworks, is a full-service contract development manufacturing organization (CDMO) offering biomanufacturing services to third-party biotech companies.

Tivic的临床管线包括治疗中性粒细胞减少症（通常由化疗引起）以及称为淋巴细胞耗竭的T细胞功能障碍状态的潜在疗法。Tivic的全资子公司Velocity Bioworks是一家全方位服务的合同开发制造组织（CDMO），为第三方生物技术公司提供生物制造服务。

Tivic also leverages Velocity Bioworks' manufacturing capabilities to advance its own drug pipeline with the expected benefits of lower costs, accelerated manufacturing outcomes and supply chain security. For more information, visit .

Tivic还利用Velocity Bioworks的生产能力来推进自己的药物研发管线，预期将带来降低成本、加快生产进度和保障供应链等好处。欲了解更多信息，请访问。

https://ir.tivichealth.com

https://ir.tivichealth.com

.

。

Forward-Looking Statements

前瞻性声明

This press release may contain 'forward-looking statements' that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as 'anticipate,' 'believe,' 'contemplate,' 'could,' 'estimate,' 'expect,' 'intend,' 'seek,' 'may,' 'might,' 'plan,' 'potential,' 'predict,' 'project,' 'target,' 'aim,' 'should,' 'will,' 'would,' or the negative of these words or other similar expressions, although not all forward-looking statements contain these words.

本新闻稿可能包含“前瞻性声明”，这些声明受到重大风险和不确定性的影响。本新闻稿中除历史事实陈述之外的所有声明均为前瞻性声明。本新闻稿中的前瞻性声明可以通过诸如“预期”、“相信”、“考虑”、“可能”、“估计”、“期望”、“意图”、“寻求”、“或许”、“也许”、“计划”、“潜在”、“预测”、“预计”、“目标”、“旨在”、“应该”、“将”、“会”等词语或这些词语的否定形式或其他类似表达来识别，尽管并非所有前瞻性声明都包含这些词语。

Forward-looking statements are based on Tivic Health Systems Inc.'s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate, including as a result of the company's interactions with and guidance from the FDA and other regulatory authorities; the continued interest of BARDA and other U.S.

前瞻性声明基于Tivic Health Systems Inc.的当前预期，并受制于固有的不确定性、风险和难以预测的假设。此外，某些前瞻性声明基于对未来事件的假设，这些假设可能被证明不准确，包括由于公司与FDA和其他监管机构的互动及指导；BARDA和其他美国机构的持续关注。

government agencies in Entolimod™; the ability of the company to achieve the expected benefits from the acquisition of development and manufacturing assets within expected time frames or at all; changes to the company's relationship with its partners; expectations regarding the potential benefits of the leadership transition; failure to obtain FDA or similar clearances or approvals and noncompliance with FDA or similar regulations, including related to the Animal Rule; the company's future development of Entolimod or Entolasta; the ability to successfully engage a formulation development partner and develop an oral transmucosal delivery formulation; change.

政府机构在Entolimod™方面；公司能否在预期时间内或完全实现从收购开发和制造资产中获得预期收益；公司与合作伙伴关系的变化；关于领导层过渡潜在益处的预期；未能获得FDA或类似批准或许可，以及未遵守FDA或类似法规，包括与动物规则相关的规定；公司未来对Entolimod或Entolasta的开发；能否成功吸引配方开发合作伙伴并开发出口腔黏膜递送配方；变化。

Investor Contact:

投资者联系方式：

Tivic Investor Relations

Tivic投资者关系

[email protected]

电子邮件地址

Media Contact:

媒体联系人：

DJ Freyman

DJ弗雷曼

[email protected]

电子邮件地址

SOURCE Tivic Health Systems, Inc.

来源：Tivic Health Systems, Inc.

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