MARKET WIRE NEWS

Polyrizon Signs an Agreement with Leading Global Preclinical CRO as Part of Clinical Development Program

MWN-AI** Summary

Polyrizon Ltd. (Nasdaq: PLRZ), a preclinical-stage biotechnology company based in Raanana, Israel, has recently entered into a significant agreement with a leading global preclinical Contract Research Organization (CRO). This partnership is pivotal to advancing Polyrizon's clinical development program, particularly in the context of developing innovative intranasal solutions aimed at creating a barrier against viruses and allergens.

The CRO, recognized for its expertise in biocompatibility and regulatory-compliant testing, will carry out comprehensive preclinical biocompatibility studies in line with ISO 10993 standards and Good Laboratory Practice (GLP) requirements. These studies, which are scheduled to begin in the second quarter of 2026, encompass a series of assessments—including cytotoxicity, sensitization, and acute systemic toxicity—essential for ensuring product safety before human trials commence later in the year.

Tomer Izraeli, CEO of Polyrizon, expressed that partnering with a globally recognized preclinical entity not only fortifies their regulatory strategy but also aligns perfectly with their anticipated timeline for initiating clinical trials. This agreement follows a series of recent achievements for Polyrizon, including the successful manufacturing of GMP clinical trial material and a productive FDA pre-submission meeting, supported by positive preclinical results demonstrating the efficacy of their allergen-blocking technology.

Polyrizon continues to execute its development roadmap, focusing on its proprietary Capture and Contain™ hydrogel technology, which is designed to provide a protective barrier within the nasal cavity. The company is also advancing its Trap and Target™ technology, aimed at enhancing intranasal delivery of active pharmaceutical ingredients. With a commitment to innovation and clinical validation, Polyrizon remains on a promising path toward addressing unmet medical needs in allergy and viral protection.

MWN-AI** Analysis

Polyrizon Ltd. (Nasdaq: PLRZ) stands at an exciting juncture following its recent agreement with a leading global preclinical Contract Research Organization (CRO). This partnership marks a pivotal development in Polyrizon's clinical trajectory, which showcases a commitment to rigorous safety evaluations essential for advancing its innovative intranasal hydrogel technology.

The timing of this agreement comes at a critical moment, as Polyrizon is nearing the initiation of its clinical trials later this year. Their proactive approach toward regulatory compliance, particularly through ISO 10993 standards and Good Laboratory Practices, strengthens their posture against regulatory scrutiny. With compelling preclinical data suggesting promising allergen-blocking performance, the company appears poised for potential breakthroughs in nasal biomedical applications.

For investors, this contract with a reputable CRO not only signals credibility but also aligns with broader industry trends where robust preclinical stages are increasingly vital to attract funding, partnerships, and favorable market positioning. As the company continues to innovate with its proprietary Capture and Contain TM hydrogel technology and develops additional capabilities under the Trap and Target ™ platform, growth potential is substantial.

However, it is critical to temper enthusiasm with caution. The biotech sector is fraught with uncertainties, particularly surrounding clinical trial outcomes and regulatory approvals. Investors should closely monitor milestones, especially as the timeline for clinical trials draws near. As with any preclinical-stage biotech venture, volatility is expected, meaning that short-term price swings may occur alongside the announcement of interim results or regulatory feedback.

In summary, while Polyrizon's partnership signals promise for those interested in the biotechnology sector, careful diligence is advised. Vigilant tracking of its regulatory progress and clinical developments will be essential for making informed investment decisions in the evolving landscape of biotech innovations.

**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.

Source: GlobeNewswire

Raanana, Israel, March 17, 2026 (GLOBE NEWSWIRE) -- Polyrizon Ltd. (Nasdaq: PLRZ) (“Polyrizon” or the “Company”), a pre-clinical-stage biotechnology company developing intranasal administrated solutions, today announced the signing of an agreement with a leading global preclinical Contract Research Organization (CRO), a recognized expert in biocompatibility and regulatory-compliant testing.

This agreement forms part of Polyrizon's ongoing efforts to advance its clinical development program, which also includes a recent manufacturing of GMP production of clinical trial material, successful completion of an FDA pre-submission meeting, and positive preclinical data demonstrating effective allergen-blocking performance.

Under the agreement, the CRO will conduct a comprehensive package of preclinical biocompatibility studies in accordance with ISO 10993 standards and GLP requirements. The studies are expected to commence in the second quarter of 2026 and represent a key milestone in Polyrizon’s potential regulatory pathway toward initiating clinical trials, which are planned to commence later this year.

The preclinical program includes cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity and pyrogenicity assessments, designed to support regulatory submissions and ensure product safety prior to human studies.

“This agreement marks an important step in the advancement of our development program,” said Tomer Izraeli, CEO of Polyrizon. “We believe that engaging a globally recognized preclinical partner strengthens our regulatory strategy and supports our expected timeline toward initiating clinical trials later this year.”

Polyrizon continues to execute its development roadmap as it advances its proprietary nasal medical device technology platform toward clinical validation.

About Polyrizon

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’s proprietary Capture and Contain TM, 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. 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 https://polyrizon-biotech.com.

Forward Looking Statements

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. For example, the Company is using forward-looking statements when it discusses ongoing efforts to advance its clinical development program and the timing and progress of its clinical trials. 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. 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. 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 subsequent filings with the SEC. Forward-looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. Polyrizon is not responsible for the contents of third-party websites.

Contacts:

Michal Efraty
Investor Relations
IR@polyrizon-biotech.com


FAQ**

What are the anticipated timelines for clinical trials following the completion of the preclinical studies for Polyrizon Ltd. PLRZ?

The anticipated timelines for clinical trials following the completion of preclinical studies for Polyrizon Ltd. (PLRZ) typically range from several months to a few years, depending on regulatory approvals, study design, and funding availability.

How does the partnership with the leading global preclinical CRO enhance Polyrizon Ltd. PLRZ's regulatory strategy for safe product development?

The partnership with a leading global preclinical CRO enhances Polyrizon Ltd. (PLRZ)'s regulatory strategy by providing access to advanced expertise and resources, enabling more efficient and compliant product development processes that ensure safety and efficacy.

Can you elaborate on the key milestones achieved by Polyrizon Ltd. PLRZ in its preclinical development leading up to the upcoming clinical trials?

Polyrizon Ltd. (PLRZ) has achieved key preclinical milestones including successful formulation development, positive results in animal models demonstrating safety and efficacy, and completion of necessary regulatory assessments, all paving the way for its upcoming clinical trials.

What specific benefits does the Capture and Contain TM hydrogel technology from Polyrizon Ltd. PLRZ offer in comparison to existing allergen and virus defense methods?

Polyrizon Ltd.'s Capture and Contain TM hydrogel technology offers superior efficacy in allergen and virus defense by encapsulating and neutralizing harmful agents, thereby preventing their entry into the body more effectively than conventional methods.

**MWN-AI FAQ is based on asking OpenAI questions about Polyrizon Ltd. (NASDAQ: PLRZ).

Polyrizon Ltd.

NASDAQ: PLRZ

PLRZ Trading

0.81% G/L:

$13.65 Last:

6,757 Volume:

$13.71 Open:

mwn-alerts Ad 300

PLRZ Latest News

PLRZ Stock Data

$21,948,636
1,472,806
N/A
1
N/A
Biotechnology & Life Sciences
Healthcare
US
Raanana

Subscribe to Our Newsletter

Link Market Wire News to Your X Account

Download The Market Wire News App