{"filing":{"accession_number":"0001776985-26-000063","cik":"0001776985","ticker":"BNTX","company_name":"BioNTech SE","form":"6-K","filing_date":"2026-09-14","report_date":"2026-09-14","primary_document":"form6-kwclcgotistobart14se.htm","primary_document_url":"https://www.sec.gov/Archives/edgar/data/1776985/000177698526000063/form6-kwclcgotistobart14se.htm"},"events":[{"id":33157,"run_id":30482,"accession_number":"0001776985-26-000063","anchor_item_number":"EX-99.1","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"summary":"This exhibit is a press release announcing updated clinical trial data for gotistobart (BNT316/ONC-392), a late-stage investigational immunotherapy co-developed by BioNTech and OncoC4. The disclosure reports positive Phase 3 trial results showing gotistobart nearly doubled median overall survival (18.5 months vs. 10.0 months) versus standard-of-care chemotherapy in previously treated squamous NSCLC patients. While this is a material clinical milestone for an oncology candidate in late-stage development with Fast Track and Breakthrough Therapy designations, it does not fit the discrete event categories (not an earnings release, M\u0026A activity, executive change, or financial obligation). It is a material operational/strategic milestone—a significant clinical readout that would affect investor assessment of the company's pipeline and commercial prospects.","company_name":"BioNTech SE","ticker":"BNTX","filing_date":"2026-09-14","form":"6-K","submitted_at":null,"items":[{"id":36526,"accession_number":"0001776985-26-000063","item_number":"EX-99.1","item_title":"a991260911_bntxwclcxgotist.htm","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"This exhibit is a press release announcing updated clinical trial data for gotistobart (BNT316/ONC-392), a late-stage investigational immunotherapy co-developed by BioNTech and OncoC4. The disclosure reports positive Phase 3 trial results showing gotistobart nearly doubled median overall survival (18.5 months vs. 10.0 months) versus standard-of-care chemotherapy in previously treated squamous NSCLC patients. While this is a material clinical milestone for an oncology candidate in late-stage development with Fast Track and Breakthrough Therapy designations, it does not fit the discrete event categories (not an earnings release, M\u0026A activity, executive change, or financial obligation). It is a material operational/strategic milestone—a significant clinical readout that would affect investor assessment of the company's pipeline and commercial prospects.","classifier_version":"claude-haiku-4-5-20251001+prompt-6be895f9","taxonomy_version":"v1.3","classified_at":"2026-09-14T12:29:45.277101+00:00","company_name":"","ticker":null,"filing_date":""}]}],"classifications":[{"id":36526,"accession_number":"0001776985-26-000063","item_number":"EX-99.1","item_title":"a991260911_bntxwclcxgotist.htm","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"This exhibit is a press release announcing updated clinical trial data for gotistobart (BNT316/ONC-392), a late-stage investigational immunotherapy co-developed by BioNTech and OncoC4. The disclosure reports positive Phase 3 trial results showing gotistobart nearly doubled median overall survival (18.5 months vs. 10.0 months) versus standard-of-care chemotherapy in previously treated squamous NSCLC patients. While this is a material clinical milestone for an oncology candidate in late-stage development with Fast Track and Breakthrough Therapy designations, it does not fit the discrete event categories (not an earnings release, M\u0026A activity, executive change, or financial obligation). It is a material operational/strategic milestone—a significant clinical readout that would affect investor assessment of the company's pipeline and commercial prospects.","classifier_version":"claude-haiku-4-5-20251001+prompt-6be895f9","taxonomy_version":"v1.3","classified_at":"2026-09-14T12:29:45.277101+00:00","company_name":"BioNTech SE","ticker":"BNTX","filing_date":"2026-09-14"}]}