Studies to assess efficacy, safety, user experience, and nasal residence time as Company prepares for regulatory path forward

公司正在准备监管路径，以评估疗效、安全性、用户体验和鼻腔停留时间的研究。

Raanana, Israel, March 27, 2025 (GLOBE NEWSWIRE) --

以色列拉阿纳纳，2025年3月27日（环球新闻社）--

Polyrizon Ltd. (Nasdaq: PLRZ), a biotech company specializing in innovative intranasal hydrogels, today announced the structuring of its clinical strategy for PL-14, the Company’s proprietary intranasal allergy blocker for seasonal allergic rhinitis.

Polyrizon Ltd.（纳斯达克股票代码：PLRZ），一家专注于创新鼻腔水凝胶的生物技术公司，今天宣布了其针对PL-14的临床策略架构，该产品是公司专有的用于季节性过敏性鼻炎的鼻腔过敏阻断剂。

The clinical strategy was updated in preparation for a planned pre-submission meeting with the U.S. Food and Drug Administration (FDA), which is expected to be followed by the initiation of clinical trials.

临床策略已更新，为与美国食品药品监督管理局 (FDA) 计划召开的预提交会议做准备，预计随后将启动临床试验。

The comprehensive clinical studies is expected to include:

预计全面的临床研究将包括：

A clinical study evaluating efficacy and safety under natural exposure conditions during peak allergy season

一项在过敏高发季节评估自然暴露条件下疗效和安全性的临床研究

A dedicated Human Factors (HF) study designed to assess usability and patient acceptance of PL-14

一项专门设计的人因工程 (HF) 研究，旨在评估 PL-14 的可用性和患者接受度。

An additional clinical study assessing the nasal residence time of the PL-14 formulation.

评估PL-14制剂鼻腔滞留时间的另一项临床研究。

Tomer Izraeli, CEO of Polyrizon, said: “Structuring our clinical plan brings us closer to our goal of advancing PL-14 toward regulatory approval and commercialization. By generating strong data around efficacy, safety and user experience, we believe PL-14 can provide meaningful value to millions suffering from allergic rhinitis.”.

Polyrizon首席执行官托默·以色列利表示：“制定我们的临床计划使我们更接近推动PL-14走向监管审批和商业化的目标。通过生成有关有效性、安全性和用户体验的有力数据，我们相信PL-14可以为数百万过敏性鼻炎患者提供有意义的价值。”

Polyrizon expects to initiate clinical trials in the U.S. and Europe in late 2025 to early 2026, following the completion of preclinical work and the upcoming FDA consultation.

Polyrizon 预计在 2025 年底至 2026 年初，在完成临床前工作和即将进行的 FDA 咨询后，将在美国和欧洲启动临床试验。

About Polyrizon Ltd.

关于Polyrizon有限公司。

Polyrizon is a development stage biotech company specializing in the development of innovative medical device hydrogels delivered in the form of nasal sprays, which form a thin hydrogel-based shield containment barrier in the nasal cavity that can provide a barrier against viruses and allergens from contacting the nasal epithelial tissue.

Polyrizon是一家处于开发阶段的生物技术公司，专注于开发以鼻喷雾形式递送的创新型医疗设备水凝胶，这种水凝胶在鼻腔内形成一层薄薄的水凝胶基屏障，可以提供针对病毒和过敏原接触鼻上皮组织的防护屏障。

Polyrizon’s proprietary Capture and Contain .

Polyrizon 的专有捕获和包含技术。

TM

商标

, or C&C, hydrogel technology, comprised of a mixture of naturally occurring building blocks, is delivered in the form of nasal sprays, and potentially functions as a “biological mask” with a thin shield containment barrier in the nasal cavity. Polyrizon are further developing certain aspects of our C&C hydrogel technology such as the bioadhesion and prolonged retention at the nasal deposition site for intranasal delivery of drugs.

或C&C水凝胶技术，由天然存在的基本成分混合而成，以鼻喷雾的形式递送，并可能在鼻腔内形成一种带有薄膜屏障的“生物面罩”。Polyrizon正在进一步开发我们C&C水凝胶技术的某些方面，例如生物粘附性和在鼻腔沉积部位的长时间滞留，以实现药物的鼻腔内递送。

Polyrizon refers to its additional technology, which is in an earlier stage of pre-clinical development, that is focused on nasal delivery of active pharmaceutical ingredients, or APIs, as Trap and Target ™, or T&T. For more information, please visit .

Polyrizon 提及其处于临床前开发早期阶段的额外技术，该技术专注于活性药物成分（API）的鼻腔递送，称为 Trap and Target™ 或 T&T。欲了解更多信息，请访问 。

https://polyrizon-biotech.com

https://polyrizon-biotech.com

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Forward Looking Statements

前瞻性声明

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and other securities laws. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates” and similar expressions or variations of such words are intended to identify forward-looking statements.

本新闻稿包含1995年《私人证券诉讼改革法》及其他证券法所指的“前瞻性陈述”。诸如“预期”、“预计”、“打算”、“计划”、“相信”、“寻求”、“估计”等词语或类似表达旨在识别前瞻性陈述。

For example, the Company is using forward-looking statements when it discusses its goal of advancing PL-14 toward regulatory approval and commercialization, its belief that PL-14 can provide meaningful value to millions suffering from allergic rhinitis and its expectation to initiate clinical trials in the U.S.

例如，公司在讨论其推动PL-14走向监管审批和商业化的目标准备时，使用了前瞻性声明。公司相信PL-14能为数百万过敏性鼻炎患者提供有意义的价值，并期望在美国启动临床试验。

and Europe in late 2025 to early 2026, following the completion of preclinical work and the upcoming FDA consultation. Forward-looking statements are not historical facts, and are based upon management’s current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain.

并在 2025 年底至 2026 年初在欧洲推出，前提是在完成临床前工作和即将进行的 FDA 咨询之后。前瞻性陈述并非历史事实，而是基于管理层当前的预期、信念和预测，其中许多本质上具有不确定性。

Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management’s expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements.

此类预期、信念和预测的表达是出于善意。然而，无法保证管理层的预期、信念和预测能够实现，实际结果可能与前瞻性陈述中所表达或暗示的内容存在重大差异。前瞻性陈述受到各种风险和不确定因素的影响，可能导致实际表现或结果与前瞻性陈述中所述的内容存在重大差异。

For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company’s reports filed from time to time with the Securities and Exchange Commission (“SEC”), including, but not limited to, the risks detailed in the Company’s annual report filed with the SEC on March 11, 2025 and subsequ.

有关影响公司的风险和不确定性的更详细描述，请参阅公司不时向美国证券交易委员会（“SEC”）提交的报告，包括但不限于公司于2025年3月11日向SEC提交的年度报告中详述的风险及其他后续文件。

Contacts:

联系人：

Michal Efraty

米哈尔·埃弗拉蒂

Investor Relations

投资者关系

IR@polyrizon-biotech.com

IR@polyrizon-biotech.com