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 January 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 January 22, 2026, titled “Polyrizon Advances Regulatory Path with Initiation of Usability
Study Program for NASARIX™ Allergy Blocker.”
The first three 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not superseded by documents or reports subsequently filed or furnished.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. |
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| 99.1 |
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Press release titled: “Polyrizon Advances Regulatory Path with Initiation of Usability Study Program for NASARIX™ Allergy Blocker” |
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: January 22, 2026 |
By: |
/s/ Tomer Izraeli |
| |
Name: |
Tomer Izraeli |
| |
Title: |
Chief Executive Officer |
Exhibit 99.1
Polyrizon Advances Regulatory Path with Initiation of Usability Study Program for NASARIX™ Allergy Blocker
Executed in accordance with FDA human factors
and usability engineering guidance, the study is intended to de-risk downstream regulatory review and support a streamlined path toward
clinical development
Raanana, Israel, Jan. 22, 2026 (GLOBE NEWSWIRE)
-- Polyrizon Ltd. (Nasdaq: PLRZ) (“Polyrizon” or the “Company”), a pre-clinical-stage biotechnology company
developing intranasal protective solutions, today announced the initiation of a key usability (Human Factors) study program for its lead
product candidate, NASARIX™, an innovative intranasal allergy blocker designed for broad consumer use.
The study marks an important value-inflection
milestone in Polyrizon’s development roadmap and is being conducted to confirm alignment with U.S. Food and Drug Administration
(FDA) requirements for critical product elements, including labeling, instructions for use, and overall user interaction. Executed in
accordance with FDA human factors and usability engineering guidance, the study is intended to de-risk downstream regulatory review and
support a streamlined path toward clinical development.
Successful completion of the usability program
will potentially provide essential regulatory evidence supporting NASARIX™ readiness for clinical evaluation. This milestone represents
an important step toward the planned initiation of Polyrizon’s clinical trials, which are expected to commence in Q3 2026, positioning
the company for continued advancement along its regulatory and potential commercialization strategy.
“This usability study is a key milestone
in advancing NASARIX™ toward clinical trials, which are expected to commence in Q3 2026,” said Tomer Izraeli, CEO of Polyrizon.
“It underscores our commitment to FDA-aligned development, patient safety, and user-centered intranasal solutions.”
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 its development roadmap, the planned initiation of Polyrizon’s
clinical trials, which are expected to commence in Q3 2026, continued advancement along its regulatory and potential commercialization
strategy and its commitment to FDA-aligned development, patient safety, and user-centered intranasal solutions. 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
