Pipeline and Programs - BioNTech has 16 clinical programs in oncology and 7 clinical programs in infectious diseases[14] - Pumitamig, a PD-L1 x VEGF-A bispecific antibody, showed an objective response rate (ORR) of 76.9% in PD-L1 negative, 56.3% in PD-L1 low, and 100% in PD-L1 high TNBC patients when combined with chemotherapy[57] - In EGFRmut NSCLC post EGFR TKI, pumitamig combined with chemo showed an ORR of 39.3% in PD-L1 negative, 60.9% in PD-L1 low, and 92.3% in PD-L1 high patients[60] - BNT324/DB-1311, an anti-B7H3 ADC, showed an ORR of 54.5% at 6 mg/kg and 58.8% at 9 mg/kg in SCLC patients who received prior IO but no prior TOP1i[209] Clinical Trials and Strategy - BioNTech is executing a three-wave strategy for Pumitamig, including foundational registrational trials, expanding into multiple disease indications, and synergistic novel-novel combinations[64] - BioNTech has over 1,400 patients dosed across pumitamig monotherapy and chemo combination studies[141] - A Phase 3 trial is evaluating Gotistobart versus docetaxel in 600 patients with 2L squamous non-small cell lung cancer[83, 179] Financials and Partnerships - BioNTech increased its 2025 revenue guidance to a range of €26 to €28 billion[437] - BioNTech has €167 billion in cash, cash equivalents, and securities[437] - BioNTech's partnership with BMS includes $35 billion upfront and non-contingent payments, plus $76 billion in milestone payments for Pumitamig[443]
BioNTech (NasdaqGS:BNTX) Earnings Call Presentation