BioNTech SE Files Form 6-K for September 2025

TL;DR

BioNTech SE filed a 6-K on Sep 5, 2025, detailing a Phase 3 trial with DualityBio.

AI Summary

On September 5, 2025, BioNTech SE announced a collaboration with Duality Biologics (Suzhou) Co., Ltd. ("DualityBio") regarding a pivotal Phase 3 trial, identified by NCT06265428. This filing is a Form 6-K report for the month of September 2025.

Why It Matters

This filing indicates ongoing clinical trial activities for BioNTech SE, potentially impacting future product development and market position.

Risk Assessment

Risk Level: low — The filing is a routine report of foreign private issuer activities and does not contain significant new financial or operational information that would immediately impact risk.

Key Players & Entities

• BioNTech SE (company) — Registrant and collaborator
• Duality Biologics (Suzhou) Co., Ltd. (company) — Collaborator
• NCT06265428 (trial_id) — Pivotal Phase 3 trial identifier
• September 5, 2025 (date) — Announcement date

FAQ

From the Filing

0001776985-25-000055.txt : 20250905 0001776985-25-000055.hdr.sgml : 20250905 20250905064403 ACCESSION NUMBER: 0001776985-25-000055 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20250905 FILED AS OF DATE: 20250905 DATE AS OF CHANGE: 20250905 FILER: COMPANY DATA: COMPANY CONFORMED NAME: BioNTech SE CENTRAL INDEX KEY: 0001776985 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] ORGANIZATION NAME: 03 Life Sciences EIN: 000000000 STATE OF INCORPORATION: 2M FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 6-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-39081 FILM NUMBER: 251294979 BUSINESS ADDRESS: STREET 1: AN DER GOLDGRUBE 12 CITY: MAINZ STATE: 2M ZIP: 55131 BUSINESS PHONE: 0049613190840 MAIL ADDRESS: STREET 1: AN DER GOLDGRUBE 12 CITY: MAINZ STATE: 2M ZIP: 55131 6-K 1 form6-kbnt3235sep2025.htm 6-K Document 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 001-39081 BioNTech SE (Translation of registrant’s name into English) An der Goldgrube 12 D-55131 Mainz Germany +49 6131-9084-0 (Address of principal executive offices) Indicate by check mark whether the registrant files or will file annual reports under cover Form 20‑F or Form 40‑F: Form 20‑F ☒ Form 40‑F ☐ Indicate by check mark if the registrant is submitting the Form 6‑K in paper as permitted by Regulation S‑T Rule 101(b)(1): ☐ Indicate by check mark if the registrant is submitting the Form 6‑K in paper as permitted by Regulation S‑T Rule 101(b)(7): ☐ DOCUMENTS INCLUDED AS PART OF THIS FORM 6-K On September 5, 2025, BioNTech SE and Duality Biologics (Suzhou) Co., Ltd. (“DualityBio”) announced that the pivotal Phase 3 trial (NCT06265428) which DualityBio is conducting in China to evaluate trastuzumab pamirtecan (BNT323/DB-1303) versus trastuzumab emtansine (T-DM1) in patients with HER2-positive unresectable or metastatic breast cancer who have previously received trastuzumab and a taxane-based chemotherapy met its primary endpoint of progression free survival at a pre-specified interim analysis. The press release is attached hereto as Exhibit 99.1. SIGNATURE Pursuant to the requirements of the Exchange Act, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized. BioNTech SE By: /s/ Ramón Zapata-Gomez By: /s/ Dr. Sierk Poetting Name: Ramón Zapata-Gomez Name: Dr. Sierk Poetting Title: Chief Financial Officer Title: Chief Operating Officer Date: September 5, 2025 EXHIBIT INDEX Exhibit Description of Exhibit 99.1 BioNTech and DualityBio Announce Phase 3 Trial of ADC Candidate BNT323/DB-1303 Met Primary Endpoint of Progression Free Survival in HER2-Positive Metastatic or Unresectable Breast Cancer EX-99.1 2 a99120250905_bnt323xdb-130.htm EX-99.1 Document Exhibit 99.1          BioNTech and DualityBio Announce Phase 3 Trial of ADC Candidate BNT323/DB-1303 Met Primary Endpoint of Progression Free Survival in HER2-Positive Metastatic or Unresectable Breast Cancer • Trastuzumab pamirtecan (BNT323/DB-1303), an investigational next-generation antibody drug-conjugate (“ADC”) targeting HER-2, met its primary endpoint of progression free survival (“PFS”) in interim analysis of a Phase 3 trial (NCT06265428) conducted in China • Positive result in the NCT06265428 trial marks milestone in BioNTech and DualityBio’s strategic collaboration initiated in April 2023 • Additional global Phase 3 DYNASTY-Breast02 trial (NCT06018337) evaluating trastuzumab pamirtecan in patients with metastatic HER2-low breast