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Polyrizon (PLRZ) lines up sites for 120-patient allergy study

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6-K

Rhea-AI Filing Summary

Polyrizon Ltd. (PLRZ) reports an operational milestone for its NASARIX™ Allergy Blocker (PL-14) program, having completed contracting with all five U.S. clinical sites for its first-in-human study. The report also incorporates portions of this update by reference into existing Form S-8 and Form F-3 registration statements.

The planned prospective, multicenter, randomized, single-blind, two-arm trial will enroll up to 120 patients with seasonal allergic rhinitis, randomized 1:1 to NASARIX™ or isotonic saline nasal spray. Primary efficacy will be measured by mean daily reflective Total Nasal Symptom Score over the first 14 treatment days, with safety based on treatment-emergent adverse events and tolerability. Polyrizon is now moving into patient pre-screening and enrollment, timed to relevant allergy seasons.

Positive

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Number of clinical sites 5 clinical sites Total U.S. sites contracted to participate in the NASARIX™ clinical study
Planned enrollment 120 patients Maximum number of randomized patients in the first-in-human NASARIX™ trial
Randomization ratio 1:1 Assignment of patients to NASARIX™ Allergy Blocker or isotonic saline nasal spray control
Primary endpoint assessment period 14 treatment days Period over which mean daily reflective Total Nasal Symptom Score (rTNSS) is evaluated
Form S-8 file numbers 333-284410 and 333-288923 Registration statements into which part of this update is incorporated by reference
Form F-3 file number 333-291368 Shelf registration statement incorporating the first six paragraphs of the press release
seasonal allergic rhinitis medical
"designed to evaluate the efficacy, safety and tolerability of NASARIX™ in patients 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.
Total Nasal Symptom Score medical
"primary efficacy endpoint will evaluate the difference between the treatment groups in mean daily reflective Total Nasal Symptom Score"
treatment-emergent adverse events medical
"Safety assessments will include the frequency and severity of treatment-emergent adverse events"
Events or symptoms that either appear for the first time or get worse after a patient starts a treatment; think of new or intensified side effects that show up once medicine or a medical device is used. Investors watch these closely because they affect whether a therapy can gain regulatory approval, be prescribed widely, or face legal and commercial setbacks—similar to how early customer complaints can sink a new product’s prospects.
prospective, multicenter, randomized, single-blind, two-arm clinical trial medical
"The planned first-in-human study is a prospective, multicenter, randomized, single-blind, two-arm clinical trial"
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.
Capture and Contain TM technical
"Polyrizon’s proprietary Capture and Contain TM, or C&C, hydrogel technology"

FAQ

What did PLRZ announce about the NASARIX™ clinical study on this 6-K?
Polyrizon Ltd. completed contracting with all five U.S. clinical sites for its first-in-human NASARIX™ Allergy Blocker study and is advancing to patient pre-screening and enrollment activities aligned with seasonal allergen exposure.

How many patients will Polyrizon (PLRZ) enroll in the NASARIX™ trial?
The NASARIX™ first-in-human clinical study is designed to enroll up to 120 randomized patients with seasonal allergic rhinitis, assigned in a 1:1 ratio to receive either NASARIX™ Allergy Blocker or an isotonic saline nasal spray control.

What is the primary endpoint of Polyrizon’s NASARIX™ study?
The primary endpoint will assess the difference in mean daily reflective Total Nasal Symptom Score (rTNSS) between treatment groups over the first 14 treatment days, evaluating efficacy in patients with seasonal allergic rhinitis.

What safety measures are included in the NASARIX™ clinical trial for PLRZ?
Safety assessments will include the frequency and severity of treatment-emergent adverse events and evaluations of local and overall tolerability in patients receiving NASARIX™ or isotonic saline nasal spray.

How is Polyrizon timing enrollment for the NASARIX™ study?
Enrollment is planned to coincide with relevant allergy seasons. Local pollen counts and weather conditions will be monitored to assess airborne allergen exposure and support the timing of recruitment.

What type of product is NASARIX™ according to Polyrizon (PLRZ)?
NASARIX™ is described as a proprietary nasal spray designed to create a protective barrier in the nasal cavity to help prevent contact between inhaled allergens and the nasal mucosa, developed as a non-drug approach for managing seasonal allergic rhinitis.

Which SEC registration statements does this Polyrizon 6-K update support?
The first six paragraphs of the press release are incorporated by reference into Polyrizon’s Form S-8 registration statements (File Nos. 333-284410 and 333-288923) and its Form F-3 registration statement (File No. 333-291368).

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Form 6-K: How Foreign Companies Report to the SEC →

 

 

 

A GUNITED 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 August 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 August 20, 2026, titled “Polyrizon Completes Clinical Site Network for NASARIX™ Study and Advances Toward Patient Enrollment.”

 

The first six 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.

 

EXHIBIT INDEX

 

Exhibit No.    
99.1   Press release titled: “Polyrizon Completes Clinical Site Network for NASARIX™ Study and Advances Toward Patient Enrollment”

 

 

1

 

 

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: August 20, 2026 By: /s/ Tomer Izraeli
  Name:  Tomer Izraeli
  Title: Chief Executive Officer

 

2

 

Exhibit 99.1

 

Polyrizon Completes Clinical Site Network for NASARIX™ Study and Advances Toward Patient Enrollment

 

Polyrizon completes contracting with all five U.S. clinical sites and advances its NASARIX™ study toward enrollment of 120 patients

 

Raanana, Israel, Aug. 20, 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 that it has completed contracting with the fourth and fifth clinical sites participating in its clinical study of NASARIX™ Allergy Blocker (PL-14).

 

With the execution of these final agreements, Polyrizon has now completed the contracting process with all five clinical sites selected to participate in the study, marking an important operational milestone in the advancement of the NASARIX™ clinical program.

 

The planned first-in-human study is a prospective, multicenter, randomized, single-blind, two-arm clinical trial designed to evaluate the efficacy, safety and tolerability of NASARIX™ in patients with seasonal allergic rhinitis. The study is designed to enroll up to 120 randomized patients, with subjects assigned in a 1:1 ratio to receive either NASARIX™ Allergy Blocker or an isotonic saline nasal spray control.

 

The study’s primary efficacy endpoint will evaluate the difference between the treatment groups in mean daily reflective Total Nasal Symptom Score (rTNSS) over the first 14 treatment days. Safety assessments will include the frequency and severity of treatment-emergent adverse events as well as assessments of local and overall tolerability.

 

Secondary efficacy measures are expected to include instantaneous Total Nasal Symptom Score (iTNSS), rhinoconjunctivitis-related quality of life, the number of symptom-free days, and use of permitted relief medication.

 

Following completion of the clinical site contracting process, Polyrizon is advancing the study into the next stage of execution, including patient pre-screening activities and preparations for enrollment. Because the study evaluates seasonal allergic rhinitis under real-world allergen exposure conditions, patient enrollment is planned to coincide with the relevant allergy seasons. Local pollen counts and weather conditions will be monitored to assess airborne allergen exposure and support the timing of recruitment.

 

“Completing agreements with all five clinical sites is an important step in moving NASARIX™ from clinical preparation toward study execution,” said Tomer Izraeli, Chief Executive Officer of Polyrizon. “With the full clinical site network now in place, our focus shifts to patient pre-screening and readiness for enrollment as seasonal allergen exposure increases. We believe this study has the potential to generate important clinical evidence regarding the efficacy, safety and tolerability of NASARIX™ and represents a significant milestone in our strategy to advance the product toward the U.S. market.”

 

 

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 timing and progress of its NASARIX™ clinical study, patient pre-screening and enrollment activities, the Company’s belief that this study has the potential to generate important clinical evidence regarding the efficacy, safety and tolerability of NASARIX™, and the Company’s strategy to advance NASARIX™ toward the U.S. market. 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

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