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Polyrizon (PLRZ) clears NASARIX biocompatibility milestone toward first human trial

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6-K

Rhea-AI Filing Summary

Polyrizon Ltd. reported that its NASARIX/Allergy Blocker nasal spray achieved successful results in a comprehensive biocompatibility evaluation program. All required biological safety tests met their predefined acceptance criteria, supporting the product’s safety profile for intranasal use.

The program followed internationally recognized standards, including the ISO 10993 series, FDA guidance and European regulatory requirements, and assessed biological endpoints, long-term systemic toxicity and toxicological risk based on final product configuration and materials. These non-clinical results are presented as a key milestone toward advancing the device to its first-in-human clinical trial and potential commercialization as a drug-free nasal barrier for managing seasonal allergic rhinitis.

Positive

  • None.

Negative

  • None.
Biocompatibility standard ISO 10993 series Standards for biological safety assessment of medical devices
Toxicological risk standard ISO 10993-17 Used for long-term systemic toxicity assessment
Risk management standard ISO 14971 Framework for medical device risk management
Forward-looking law reference 1995 Private Securities Litigation Reform Act of 1995 cited
Latest annual report year 2025 Form 20-F for year ended December 31, 2025 referenced for risks
biocompatibility evaluation program medical
"announced successful results from its biocompatibility evaluation program for its proprietary Allergy Blocker nasal spray"
ISO 10993 regulatory
"in accordance with internationally recognized standards for biological safety assessment of medical devices, including the ISO 10993 series"
A family of international standards for testing whether materials and medical devices are safe to touch or put into the human body, covering chemical, biological and toxicological tests. Investors should care because meeting these standards is often required for regulatory approval and market access; think of it as a safety passport that reduces the risk of product recalls, delays, or extra testing that can affect costs and sales timelines.
seasonal allergic rhinitis medical
"intended to help reduce exposure to airborne allergens associated with seasonal allergic rhinitis"
Seasonal allergic rhinitis, commonly called hay fever, is an immune reaction that causes sneezing, runny or blocked nose, itchy eyes and throat when a person inhales seasonal airborne allergens like pollen. For investors it matters because it drives predictable demand for allergy medicines, over‑the‑counter products and clinical trials, affects workforce productivity and healthcare spending, and can influence sales seasonality the same way an annual weather pattern shapes retail demand.
Capture and Contain TM technical
"Polyrizon’s proprietary Capture and Contain TM, or C&C, hydrogel technology"
Trap and Target technical
"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"
forward-looking statements regulatory
"This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995"
Forward-looking statements are predictions or plans that companies share about what they expect to happen in the future, like estimating sales or profits. They matter because they help investors understand a company's outlook, but since they are based on guesses and assumptions, they can sometimes be wrong.
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Form 6-K: How Foreign Companies Report to the SEC →
 

 

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 July 2026

 

Commission file number: 001-42375

 

Polyrizon Ltd.

(Translation of registrant’s name into English)

 

8 Ha-Pnina Street

Raanana, 4321545, 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 July 2, 2026, titled “Polyrizon Announces Successful Results for NASARIX™ Biocompatibility Program, Supporting Advancement Towards First in Human Clinical Trial.”

 

The first five 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 Announces Successful Results for NASARIX™ Biocompatibility Program, Supporting Advancement Towards First in Human Clinical Trial”

 

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: July 2, 2026 By: /s/ Tomer Izraeli
  Name:  Tomer Izraeli
  Title: Chief Executive Officer

 

3

 

Exhibit 99.1

 

Polyrizon Announces Successful Results for NASARIX™ Biocompatibility Program, Supporting Advancement Towards First in Human Clinical Trial 

 

Raanana, Israel, July 02, 2026 (GLOBE NEWSWIRE) -- Polyrizon Ltd. (Nasdaq: PLRZ) (the “Company” or “Polyrizon”), a development-stage biotech company specializing in the development of innovative intranasal hydrogels, today announced successful results from its biocompatibility evaluation program for its proprietary NASARIXTM Allergy Blocker nasal spray, with all required biological safety tests meeting their predetermined acceptance criteria.

 

The comprehensive evaluation program was designed in accordance with internationally recognized standards for biological safety assessment of medical devices, including the ISO 10993 series, FDA guidance, and applicable European regulatory requirements. The program was developed to assess the safety and biocompatibility profile of NASARIXTM, a drug-free mucoadhesive nasal spray intended to help reduce exposure to airborne allergens associated with seasonal allergic rhinitis.

 

The completed testing program evaluated key biological safety endpoints identified for the device, including:

 

●Cytotoxicity

 

●Sensitization

 

●Irritation / Intracutaneous Reactivity

 

●Material-Mediated Pyrogenicity

 

●Acute Systemic Toxicity

 

In addition, long-term systemic toxicity was assessed through a toxicological risk assessment conducted in accordance with ISO 10993-17, demonstrating substantial safety margins across the product’s constituent materials under intended conditions of use.

 

The biocompatibility evaluation was based on the final NASARIXTM product configuration and supported by extensive toxicological assessments of the formulation components, manufacturing processes, packaging materials, and intended patient exposure. According to the Biological Evaluation Plan, the product consists of well-characterized materials with established safety profiles and utilizes a manufacturing process designed to minimize biological risk.

 

“We are pleased to report the successful completion of the NASARIXTM biocompatibility program,” said Tomer Izraeli, CEO of Polyrizon. “Achieving positive results across all required biological safety assessments represents a significant milestone in our development program and further supports the biocompatibility safety profile of NASARIXTM as we continue advancing its clinical and regulatory pathway.”

 

The biocompatibility evaluation program was developed under a risk-management framework consistent with ISO 10993-1 and ISO 14971 and included assessment of physical and chemical characteristics, material safety data, toxicological literature, manufacturing controls, and endpoint-specific biological testing.

 

The successful completion of the biocompatibility program further strengthens the non-clinical package supporting NASARIXTM and represents an important step toward potential commercialization of the product as a novel nasal barrier technology designed to help individuals suffering from seasonal allergies.

 

About NASARIXTM

 

NASARIXTM is Polyrizon’s proprietary nasal spray designed to create a protective barrier within the nasal cavity, helping to prevent contact between inhaled allergens and the nasal mucosa. The product is being developed as a non-drug approach for the management of seasonal allergic rhinitis.

 

 

 

 

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 the the timing and progress of its clinical trials, advancing the clinical and regulatory pathway of NASARIXTM and the potential commercialization of NASARIXTM as a novel nasal barrier technology designed to help individuals suffering from seasonal allergies. 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 on Form 20-F for the fiscal year ended December 31, 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

 

 

 

Source: View Original Filing on SEC EDGAR

FAQ

What did Polyrizon (PLRZ) announce in its July 2026 6-K filing?

Polyrizon announced that its NASARIX/Allergy Blocker nasal spray completed a biocompatibility program with all required biological safety tests meeting predefined criteria, supporting advancement toward a first-in-human clinical trial and potential future commercialization.

What is NASARIX/Allergy Blocker in Polyrizon’s (PLRZ) pipeline?

NASARIX/Allergy Blocker is a proprietary, drug-free mucoadhesive nasal spray designed to create a protective barrier in the nasal cavity, helping reduce exposure to airborne allergens associated with seasonal allergic rhinitis as a non-drug management approach.

Which standards guided Polyrizon’s NASARIX biocompatibility program?

The biocompatibility program followed internationally recognized standards, including the ISO 10993 series, FDA guidance, European regulatory requirements and a Biological Evaluation Plan, with additional risk-management principles from ISO 10993-1, ISO 10993-17 and ISO 14971.

How did Polyrizon assess safety for the NASARIX nasal spray?

Safety was assessed through biological safety endpoints, long-term systemic toxicity evaluation and toxicological risk assessment of formulation components, manufacturing processes, packaging materials and intended patient exposure, all based on the final product configuration and established material safety profiles.

What stage of development is Polyrizon’s NASARIX program at now?

With the biocompatibility program successfully completed, Polyrizon describes this as a significant non-clinical milestone that supports advancing NASARIX toward its first-in-human clinical trial and contributes to the non-clinical package for potential future commercialization.

What technologies is Polyrizon (PLRZ) developing beyond NASARIX?

Polyrizon is developing its Capture and Contain (C&C) hydrogel technology for nasal barrier sprays and an earlier-stage Trap and Target (T&T) platform focused on intranasal delivery of active pharmaceutical ingredients using hydrogel-based nasal formulations.

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