Polyrizon details FDA pre-submission for PL-14

Accepted by SEC EDGAR 09/19/2025 - 08:39 AM EDT Learn about SEC filing dates

Rhea-AI Filing Summary

Polyrizon Ltd., a foreign private issuer based in Israel, filed a Form 6-K reporting that it has furnished a press release titled “Polyrizon Submits Pre-Sub Package to the FDA for PL-14 Allergy Blocker.” This indicates the company has initiated a formal pre-submission interaction with the U.S. Food and Drug Administration regarding its PL-14 Allergy Blocker product. The first two paragraphs of this press release are incorporated by reference into Polyrizon’s existing employee equity Registration Statements on Form S-8, making that information part of those registration statements from the date of this report, unless later superseded.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Polyrizon Ltd. (PLRZ) report in this Form 6-K?

Polyrizon reported that it furnished a press release titled “Polyrizon Submits Pre-Sub Package to the FDA for PL-14 Allergy Blocker” and filed it as Exhibit 99.1.

What is the subject of Polyrizon’s attached press release about PL-14?

The press release is titled “Polyrizon Submits Pre-Sub Package to the FDA for PL-14 Allergy Blocker,” indicating a pre-submission package was sent to the FDA for PL-14.

How is this Form 6-K related to Polyrizon’s Form S-8 registrations?

The first two paragraphs of the attached press release are incorporated by reference into Polyrizon’s Registration Statements on Form S-8 (File Nos. 333-284410 and 333-288923).

Which exhibit is included with Polyrizon’s September 2025 Form 6-K?

Exhibit 99.1 is included, consisting of the press release titled “Polyrizon Submits Pre-Sub Package to the FDA for PL-14 Allergy Blocker.”

Who signed the Polyrizon (PLRZ) Form 6-K and in what capacity?

The Form 6-K was signed on behalf of Polyrizon Ltd. by Tomer Izraeli, who is identified as the Chief Executive Officer.

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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 September 2025

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 September 19, 2025, titled “Polyrizon Submits Pre-Sub Package to the FDA for PL-14 Allergy Blocker.”

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), 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 Submits Pre-Sub Package to the FDA for PL-14 Allergy Blocker”

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: September 19, 2025	By:	/s/ Tomer Izraeli
	Name:	Tomer Izraeli
	Title:	Chief Executive Officer

2