Polyrizon (Nasdaq: PLRZ) signs first U.S. clinical site for NASARIX PL-14 allergy study

Rhea-AI Filing Summary

Polyrizon Ltd. reports that it has signed its first Clinical Trial Agreement with a U.S.-based allergy research site in Texas, advancing its PL-14 NASARIX™ Allergy Blocker program toward human clinical testing. This site will be the first center in a planned multi-center study in patients with seasonal allergic rhinitis.

The trial, titled “Evaluation of the Efficacy, Safety, and Tolerability of PL-14 Allergy Blocker Compared to Saline Spray in Patients with Seasonal Allergic Rhinitis,” will assess an intranasal spray designed to form a protective barrier against airborne allergens. The study is planned under international Good Clinical Practice standards as Polyrizon moves from development into potential clinical validation.

Insights

Biotech clinical development analyst

Polyrizon secures its first U.S. site for a planned PL-14 allergy trial, moving closer to human data.

Polyrizon has signed a Clinical Trial Agreement with a Texas-based allergy research site for its PL-14 NASARIX™ Allergy Blocker. The study will compare PL-14 against saline in patients with seasonal allergic rhinitis, focusing on efficacy, safety, and tolerability.

The product is described as an investigational intranasal hydrogel that creates a non-pharmacological barrier to airborne allergens. The trial will follow international Good Clinical Practice guidelines, aligning with broader regulatory expectations and supporting a transition from purely development-stage work toward potential clinical validation.

This step does not include clinical results or timelines, but it does indicate operational progress toward initiating a first-in-human, multi-center trial. Subsequent disclosures on study start, enrollment progress, and top-line data will be important to understand PL-14’s clinical performance and regulatory trajectory.

Key Terms

Clinical Trial Agreement (CTA), Good Clinical Practice (GCP), seasonal allergic rhinitis, intranasal hydrogels, +2 more

6 terms

Clinical Trial Agreement (CTA) regulatory

"announced the signing of its first Clinical Trial Agreement (CTA) with a U.S.-based clinical research site"

Good Clinical Practice (GCP) regulatory

"The trial will be conducted in accordance with international Good Clinical Practice (GCP) standards"

seasonal allergic rhinitis medical

"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.

intranasal hydrogels technical

"a development-stage biotech company specializing in the development of innovative intranasal hydrogels"

Intranasal hydrogels are soft, water-rich gel medicines applied inside the nose that cling to nasal tissue and release drugs slowly over time, like a small gel patch that delivers medication directly where it can be absorbed. They matter to investors because this delivery approach can make drugs more effective or convenient, enable treatments that otherwise fail when swallowed, reduce side effects or dosing frequency, and therefore influence clinical success, regulatory approval and commercial potential.

Capture and Contain TM (C&C) hydrogel technology technical

"Polyrizon’s proprietary Capture and Contain TM, or C&C, hydrogel technology"

Trap and Target (T&T) technical

"Polyrizon refers to its additional technology ... as Trap and Target, or T&T"

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 May 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 May 13, 2026, titled “Polyrizon Advances Towards Human Clinical Trials: Secures First U.S. Clinical Site for NASARIX™ Allergy Blocker Clinical Trial.”

The first two 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 Advances Towards Human Clinical Trials: Secures First U.S. Clinical Site for NASARIX™ Allergy Blocker Clinical Trial”

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: May 13, 2026	By:	/s/ Tomer Izraeli
	Name:	Tomer Izraeli
	Title:	Chief Executive Officer

2

Exhibit 99.1

Polyrizon Advances Towards Human Clinical Trials: Secures First U.S. Clinical Site for NASARIX™ Allergy Blocker Clinical Trial

Raanana, Israel, May 13, 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 the signing of its first Clinical Trial Agreement (CTA) with a U.S.-based clinical research site specializing in allergy studies, marking a key milestone toward the initiation of its clinical program for the NASARIX^TM (PL-14) Allergy Blocker.

The clinical site, located in Texas, will serve as the first participating center in Polyrizon’s planned multi-center study evaluating the safety, tolerability, and efficacy of the NASARIX^TM Allergy Blocker in patients with seasonal allergic rhinitis.

The clinical study, titled “Evaluation of the Efficacy, Safety, and Tolerability of PL-14 Allergy Blocker Compared to Saline Spray in Patients with Seasonal Allergic Rhinitis”, will assess the performance of Polyrizon’s investigational nasal spray designed to create a protective barrier against airborne allergens.

“This agreement represents an important step in transitioning NASARIX^TM from development stage into potential clinical validation,” said Tomer Izraeli, CEO of Polyrizon. “We are pleased to collaborate with an experienced clinical team as we advance toward initiating our first-in-human clinical study.”

The study is planned as a multi-center trial, with additional clinical sites expected to be added in the coming months. The trial will be conducted in accordance with international Good Clinical Practice (GCP) standards and applicable regulatory requirements, supporting Polyrizon’s broader regulatory strategy.

NASARIX^TM is an investigational intranasal formulation designed to provide a non-pharmacological barrier against allergens, with the goal of preventing allergic reactions at the point of entry.

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 clinical trials and studies and transitioning NASARIX^TM from development stage into potential clinical validation.  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

FAQ

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

Polyrizon announced it signed its first U.S. Clinical Trial Agreement for its PL-14 NASARIX™ Allergy Blocker. The Texas clinical site will participate in a multi-center study evaluating efficacy, safety, and tolerability in seasonal allergic rhinitis under international Good Clinical Practice standards.

What is Polyrizon’s PL-14 NASARIX Allergy Blocker intended to do?

PL-14 NASARIX Allergy Blocker is an investigational intranasal formulation designed to create a barrier against airborne allergens. The goal is to prevent allergic reactions at the point of entry in the nasal cavity, offering a non-pharmacological approach for people with seasonal allergic rhinitis.

Where is Polyrizon’s first U.S. clinical trial site located for PL-14?

The first U.S. clinical site for Polyrizon’s PL-14 NASARIX Allergy Blocker trial is in Texas at an allergy-focused clinical research center. This site will be the initial location in a planned multi-center human study in patients with seasonal allergic rhinitis.

What will Polyrizon’s planned PL-14 clinical study evaluate?

The planned study, titled “Evaluation of the Efficacy, Safety, and Tolerability of PL-14 Allergy Blocker Compared to Saline Spray,” will compare PL-14 to saline. It will assess efficacy, safety, and tolerability in patients suffering from seasonal allergic rhinitis in a multi-center setting.

How does Polyrizon’s hydrogel technology work in its nasal sprays?

Polyrizon’s proprietary hydrogel technology forms a thin containment barrier in the nasal cavity. Delivered via nasal spray, it is designed to act as a “biological mask,” capturing and containing viruses or allergens before they contact nasal epithelial tissue and potentially cause reactions.

What other technologies is Polyrizon (PLRZ) developing beyond PL-14?

Beyond PL-14, Polyrizon is advancing its Capture and Contain (C&C) hydrogel platform and an earlier-stage Trap and Target (T&T) technology. T&T focuses on intranasal delivery of active pharmaceutical ingredients using enhanced bioadhesion and prolonged retention in the nasal cavity.

Filing Exhibits & Attachments

1 document

Press Releases

• EX-99.1 PRESS RELEASE TITLED: "POLYRIZON ADVANCES TOWARDS HUMAN CLINICAL TRIALS: SECURES 12.7 KB