First patient marks Polyrizon’s transition into a clinical-stage company.

The U.S clinical study is designed to evaluate the efficacy, safety and tolerability of the NASARIX (PL-14) Allergy Blocker in patients with seasonal allergic rhinitis

Raanana, Israel, Sept. 22, 2026 (GLOBE NEWSWIRE) -- Polyrizon Ltd. (Nasdaq: PLRZ) (the “Company” or “Polyrizon”), a clinical- stage biotech company specializing in the development of innovative intranasal hydrogels, today announced the enrollment of the first patient in its U.S. clinical study to evaluate NASARIX (PL-14), the Company’s investigational Allergy Blocker, in patients with seasonal allergic rhinitis (SAR).

The enrollment of the first patient represents a significant milestone for Polyrizon and marks the Company’s transition into the clinical stage of development.

“This is a defining milestone for Polyrizon,” said Tomer Izraeli, Chief Executive Officer of Polyrizon. “The enrollment of the first patient in our U.S. study represents the culmination of extensive product development, preclinical evaluation, manufacturing and regulatory preparation, and moves NASARIX into clinical evaluation in patients for the first time. We believe this study represents an important step toward our goal of developing a differentiated, drug-free approach for people suffering from seasonal allergies.”

NASARIX is a non-pharmacological, drug-free, mucoadhesive hydrogel nasal spray designed to form a physical barrier within the nasal cavity. The barrier is intended to reduce contact between inhaled airborne allergens and the nasal mucosa, thereby helping alleviate symptoms associated with allergic rhinitis.

The prospective, multicenter, randomized, single-blind, two-arm study is expected to randomize 120 patients at 5 clinical sites in the United States. Participants will be randomized 1:1 to receive either NASARIX Allergy Blocker or a saline nasal spray comparator.

The study is designed to evaluate the efficacy, safety and tolerability of NASARIX in adults with seasonal allergic rhinitis. The primary efficacy endpoint will assess the difference in mean daily reflective Total Nasal Symptom Score (rTNSS) between PL-14 and the saline comparator 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.

“Moving the NASARIX Allergy Blocker into a first-in-human clinical study is an important step in the development of our Capture and Contain™ technology from concept through product development and preclinical evaluation,” said Dr. Tidhar Turgeman, Chief Technology Officer of Polyrizon. “The study has been designed to generate data regarding efficacy and safety under real-world seasonal allergen exposure. We look forward to advancing enrollment across our U.S. clinical sites and evaluating NASARIX’s potential as a drug-free option for patients with seasonal allergic rhinitis.”

About NASARIX^TM

NASARIX^TM 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 clinical- 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 is further developing certain aspects of its 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 expected conduct, timing and progress of the NASARIX (PL-14) clinical study, including patient enrollment, the anticipated number of patients and clinical sites, the study’s evaluation of efficacy, safety and tolerability, the generation of clinical data, and NASARIX’s potential as a drug-free option for patients with seasonal allergic rhinitis. 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