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Polyrizon (PLRZ) signs global CRO pact to advance nasal hydrogel trials

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6-K

Rhea-AI Filing Summary

Polyrizon Ltd. reports that it has signed an agreement with a leading global preclinical contract research organization to support its clinical development program for intranasal hydrogel-based medical devices. The CRO will run a package of biocompatibility studies under ISO 10993 standards and GLP requirements.

The studies are expected to begin in the second quarter of 2026 and are described as a key milestone on Polyrizon’s regulatory path toward starting clinical trials planned for later this year. The program will test cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity and pyrogenicity to help demonstrate product safety before human studies.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

Form 6-K

 

Report of Foreign Private Issuer

Pursuant to Rule 13a-16 or 15d-16

under the Securities Exchange Act of 1934

 

For the month of March 2026

 

Commission file number: 001-42375

 

Polyrizon Ltd.

(Translation of registrant’s name into English)

 

5 Ha-Tidhar Street

Raanana, 4366507, Israel

(Address of principal executive offices)

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

 

Form 20-F ☒    Form 40-F ☐ 

 

 

 

 

 

 

CONTENTS

 

Attached hereto and incorporated herein is the Registrant’s press release issued on March 17, 2026, titled “Polyrizon Signs an Agreement with Leading Global Preclinical CRO as Part of Clinical Development Program.”

 

The first four paragraphs of the press release attached to this Report of Foreign Private Issuer on Form 6-K as Exhibit 99.1 are incorporated by reference into the Registrant’s Registration Statements on Form S-8 (File No. 333-284410 and 333-288923) and Form F-3 (333-291368), filed with the Securities and Exchange Commission, to be a part thereof from the date on which this report is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.

 

1

 

 

EXHIBIT INDEX

 

Exhibit No.    
99.1   Press release titled: “Polyrizon Signs an Agreement with Leading Global Preclinical CRO as Part of Clinical Development Program”

 

2

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

  Polyrizon Ltd.
   
Date: March 17, 2026 By: /s/ Tomer Izraeli
  Name:  Tomer Izraeli
  Title: Chief Executive Officer

 

 

3

Exhibit 99.1

 

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

 

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 did Polyrizon (PLRZ) announce in its March 2026 Form 6-K?

Polyrizon announced it signed an agreement with a leading global preclinical CRO to conduct biocompatibility studies. These studies support its regulatory pathway and are part of advancing its intranasal hydrogel-based medical device platform toward planned clinical trials later in 2026.

How does the new CRO agreement support Polyrizon’s PLRZ clinical development program?

The CRO will run a comprehensive battery of preclinical biocompatibility tests under ISO 10993 and GLP standards. These studies are intended to support regulatory submissions and provide safety data needed before initiating human clinical trials for Polyrizon’s nasal hydrogel medical device technology.

When are Polyrizon’s new preclinical studies expected to start and what is the goal?

The preclinical biocompatibility studies are expected to commence in the second quarter of 2026. Their goal is to generate safety data for regulatory filings and help clear the path toward starting Polyrizon’s planned clinical trials later in the same year.

What types of biocompatibility tests will Polyrizon’s CRO partner perform?

The program includes cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity and pyrogenicity assessments. Together these tests are designed to evaluate biocompatibility and support regulatory submissions before progressing Polyrizon’s intranasal hydrogel products into human clinical studies.

What technology is Polyrizon (PLRZ) developing for its nasal medical device platform?

Polyrizon is developing proprietary hydrogel technologies delivered as nasal sprays, branded Capture and Contain (C&C) and Trap and Target (T&T). The hydrogels aim to form a thin barrier in the nasal cavity against viruses and allergens and may also enable intranasal drug delivery.

How does this 6-K relate to Polyrizon’s existing SEC registration statements?

The first four paragraphs of the press release are incorporated by reference into Polyrizon’s Form S-8 registration statements and its Form F-3 registration statement. This means that information about the CRO agreement and development progress becomes part of those effective SEC registration documents.

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Polyrizon Ltd

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