PolyPid passes Israeli GMP inspection for D-PLEX100

Accepted by SEC EDGAR 09/16/2025 - 08:36 AM EDT Learn about SEC filing dates

Rhea-AI Filing Summary

PolyPid Ltd. furnishes a Form 6-K to report that it has issued a press release titled “PolyPid Successfully Completes Israeli Ministry of Health GMP Inspection, Advancing Towards Commercial Manufacturing Readiness for D-PLEX₁₀₀.” The company also states that specific portions of this press release and its forward-looking statements section are incorporated by reference into multiple existing Form F-3 and Form S-8 registration statements, so those filings now include this new information from the date of this report.

Insights

Biopharma regulatory and capital markets analyst

PolyPid reports an Israeli GMP inspection success and updates related registration statements.

PolyPid Ltd. highlights a successful Israeli Ministry of Health GMP inspection connected to D-PLEX₁₀₀, described as a step toward commercial manufacturing readiness. A completed GMP inspection by a national health authority is an important prerequisite for producing a medicine under quality standards, and can be a key milestone on the path toward commercialization.

The company also incorporates the first, second and fourth paragraphs of the press release, plus its forward-looking statements section, into several existing Form F-3 and Form S-8 registration statements. This means any descriptions and forward-looking information in those sections now formally form part of those securities-related filings from the date of this report, aligning disclosure across offerings.

FAQ

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

What did PolyPid (PYPD) report in this Form 6-K?

PolyPid reported that it issued a press release titled “PolyPid Successfully Completes Israeli Ministry of Health GMP Inspection, Advancing Towards Commercial Manufacturing Readiness for D-PLEX₁₀₀,” and furnished that release as an exhibit.

What milestone did PolyPid achieve related to D-PLEX₁₀₀?

According to the press release title, PolyPid successfully completed an Israeli Ministry of Health GMP inspection, which it describes as advancing toward commercial manufacturing readiness for D-PLEX₁₀₀.

Which PolyPid registration statements are affected by this 6-K?

PolyPid states that parts of the press release and its forward-looking statements section are incorporated by reference into its registration statements on Form F-3 and Form S-8 identified in the document.

Which parts of the press release are incorporated into PolyPid’s registration statements?

The company incorporates the first, second and fourth paragraphs of the press release, as well as the section titled “Forward-looking Statements,” into the specified Form F-3 and Form S-8 registration statements.

Who signed this PolyPid Form 6-K?

The Form 6-K was signed on behalf of PolyPid Ltd. by Dikla Czaczkes Akselbrad, who is identified as Chief Executive Officer.

What exhibit is attached to this PolyPid Form 6-K?

The filing lists one exhibit, a press release dated September 16, 2025, titled “PolyPid Successfully Completes Israeli Ministry of Health GMP Inspection, Advancing Towards Commercial Manufacturing Readiness for D-PLEX₁₀₀.”

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

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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: 001-38428

PolyPid Ltd.

(Translation of registrant’s name into English)

18 Hasivim Street

Petach Tikva 495376, Israel

(Address of principal executive office)

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 PolyPid Ltd.’s (the “Registrant”) press release issued on September 16, 2025, titled “PolyPid Successfully Completes Israeli Ministry of Health GMP Inspection, Advancing Towards Commercial Manufacturing Readiness for D-PLEX₁₀₀.” 

The first, second and the fourth paragraphs and the section titled “Forward-looking Statements” in the press release are incorporated by reference into the Company’s registration statements on Form F-3 (File No. 333-276826, File No. 333-280658, File No. 333-281863, File No. 333-284376 and File No. 333-289034) and Form S-8 (File No. 333-239517, File No. 333-271060, File No. 333-277703, File No. 333-280662 and File No. 333-289570) 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. 

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EXHIBIT INDEX

Exhibit No.
99.1		Press release issued by PolyPid Ltd. on September 16, 2025, titled “PolyPid Successfully Completes Israeli Ministry of Health GMP Inspection, Advancing Towards Commercial Manufacturing Readiness for D-PLEX₁₀₀.”

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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.

	POLYPID LTD.
Date: September 16, 2025	By:	/s/ Dikla Czaczkes Akselbrad
		Name:	Dikla Czaczkes Akselbrad
		Title:	Chief Executive Officer

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