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

From the Filing

0001776985-25-000069.txt : 20251208 0001776985-25-000069.hdr.sgml : 20251208 20251208063720 ACCESSION NUMBER: 0001776985-25-000069 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20251206 FILED AS OF DATE: 20251208 DATE AS OF CHANGE: 20251208 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: 251554572 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-kgotistobartnaclc8de.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 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 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 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 EX-99.1 2 a991251204_bntxxgotistobar.htm EX-99.1 Document 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 • Selective Treg modulator gotistobart (BNT316/ONC-392) showed a reduction in the risk of death by more than half compared to standard of care chemotherapy and a manageable safety profile in the first of two stages of the global Phase 3 trial PRESERVE-003 in patients with squamous non-small cell lung cancer (“sqNSCLC”) who have progressed on prior immunotherapy plus chemotherapy • Median OS with gotistobart has not been reached at almost 15 months of follow-up, compared to a median OS of 10 months observed with chemotherapy • As a chemotherapy-free monotherapy, gotistobart has the potential to become a