BioNTech SE Files Form 6-K for December 2025

TL;DR

BNTX filed a 6-K on Dec 8, 2025, showing data from a non-pivotal study with OncoC4.

AI Summary

On December 6, 2025, BioNTech SE and OncoC4, Inc. presented data from their non-pivotal study. The filing is a Form 6-K, indicating it's a report of a foreign private issuer for the month of December 2025.

Why It Matters

This filing provides an update on BioNTech's ongoing activities and data presentations, which could influence investor perception of their research and development pipeline.

Risk Assessment

Risk Level: low — This is a routine filing (Form 6-K) reporting on data presentation, not a material event like an acquisition or earnings miss.

Key Players & Entities

• BioNTech SE (company) — Registrant and presenter of data
• OncoC4, Inc. (company) — Collaborator presenting data with BioNTech
• December 6, 2025 (date) — Date of data presentation
• December 2025 (date) — Reporting period for the Form 6-K
• December 8, 2025 (date) — Filing date of the Form 6-K

FAQ

Filing Documents

• form6-kgotistobartnaclc8de.htm (6-K) — 14KB
• a991251204_bntxxgotistobar.htm (EX-99.1) — 41KB
• image_2a.jpg (GRAPHIC) — 19KB
• image_3a.jpg (GRAPHIC) — 3KB
• 0001776985-25-000069.txt ( ) — 87KB

From the Filing

Document UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a16 OR 15d16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 FOR THE MONTH OF DECEMBER 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 20F or Form 40F Form 20F Form 40F Indicate by check mark if the registrant is submitting the Form 6K in paper as permitted by Regulation ST Rule 101(b)(1) Indicate by check mark if the registrant is submitting the Form 6K in paper as permitted by Regulation ST Rule 101(b)(7) DOCUMENTS INCLUDED AS PART OF THIS FORM 6-K On December 6, 2025, BioNTech SE (Nasdaq BNTX, "BioNTech") and OncoC4, Inc. ("OncoC4") presented data from the non-pivotal dose-confirmation stage of the global randomized Phase 3 trial PRESERVE-003 (NCT05671510) for gotistobart (also known as BNT316 or ONC-392), a tumor microenvironment-selective regulatory T cell ("Treg") depletion candidate, targeting CTLA-4 in patients with metastatic squamous non-small cell lung cancer (sqNSCLC). 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 Ramon Zapata-Gomez By s Dr. Sierk Poetting Name Ramon Zapata-Gomez Name Dr. Sierk Poetting Title Chief Financial Officer Title Chief Operating Officer Date December 8, 2025 EXHIBIT INDEX Exhibit Description of Exhibit 99.1 BioNTech and OncoC4 Announce Clinically Meaningful Overall Survival Benefit for Selective Treg Modulator Gotistobart in Patients with Previously Treated Squamous Non-Small Cell Lung Cancer

View Full Filing

View this 6-K filing on SEC EDGAR