BioNTech, Bristol Myers Squibb Present Interim Data From Global Randomized Phase 2 Trial Evaluating Pumitamig, Investigational Bispecific Antibody Targeting PD-L1 X VEGF-A, Plus Chemotherapy In ES-SCLC Patients

• PD-L1xVEGF-A bispecific antibody pumitamig (BNT327/BMS986545) plus chemotherapy continues to show encouraging antitumor activity in patients with extensive-stage small cell lung cancer ("ES-SCLC"), expanding evidence for its potential to set a new standard of care in first-line ES-SCLC and beyond
• Global interim Phase 2 data showed a 76.3% confirmed objective response rate (cORR), 100% disease control rate (DCR), a median progression free survival (mPFS) of 6.8 months and a manageable safety profile
• Data confirm dose selection for the ongoing global pivotal Phase 3 ROSETTA LUNG-01 trial

MAINZ, Germany, and PRINCETON, USA, September 8, 2025 – BioNTech SE (NASDAQ:BNTX, "BioNTech"))) and Bristol Myers Squibb Company (NYSE:BMY, "BMS"))) today presented interim data from a global randomized Phase 2 trial (NCT06449209) evaluating pumitamig (also known as BNT327 or BMS986545), an investigational bispecific antibody targeting PD-L1 x VEGF-A, plus chemotherapy in patients with extensive-stage small cell lung cancer ("ES-SCLC"). The data, which are consistent with data presented at the European Lung Cancer Congress ("ELCC") 2025 from a Phase 2 trial conducted in China (NCT05844150), showed encouraging anti-tumor responses with a positive trend in the secondary endpoint progression free survival. Pumitamig plus chemotherapy demonstrated a manageable safety profile with no new safety signals and a low discontinuation rate. The data are being presented today as a late-breaker oral presentation at the IASLC 2025 World Conference on Lung Cancer ("WCLC") hosted by the International Association for the Study of Lung Cancer in Barcelona.

A global randomized Phase 3 trial, ROSETTA-LUNG-01 (NCT06712355), evaluating pumitamig plus chemotherapy versus atezolizumab plus chemotherapy as a first-line treatment in patients with untreated ES-SCLC is ongoing. The pivotal trial is enrolling patients at clinical trial sites in the United States, the United Kingdom, Türkiye, China, the Republic of Korea, and Australia with additional sites planned to open globally. Pumitamig received Orphan Drug designation from the U.S. Food and Drug Administration ("FDA") for the treatment of patients with small cell lung cancer in 2025.