Workflow
mRNA Cancer Immunotherapy
icon
Search documents
BioNTech SE(BNTX) - 2025 Q1 - Earnings Call Presentation
2025-05-05 12:04
Oncology Pipeline Updates - BNT327 Phase 2 data in 1L SCLC was presented, and first BNT327+ADC combo data with TROP2-targeting ADC, BNT325/DB-1305 was reported[11] - Phase 1 data for BNT116 in NSCLC was reported[11] - BNT323/DB-1303 is preparing for regulator discussions with planned BLA submission by the end of 2025, pending regulatory feedback[11] - BNT327 combined with chemotherapy indicated encouraging efficacy in 1L TNBC with a confirmed ORR of 738% (95% CI: 580, 861), median PFS of 135 months (95% CI: 94, 193), 12-month OS rate of 808% (95% CI: 653, 899), and 18-month OS rate of 697% (95% CI: 527, 816) in a Phase 1/2 study[34] - BNT327 combined with chemotherapy indicated encouraging efficacy in 1L ES-SCLC with a confirmed ORR of 854% (95% CI: 722, 939), median PFS of 69 months (95% CI: 434, 821), and median OS of 168 months (95% CI: 143, --) in a Phase 2 study[37] - In a Phase 1b/2a study, BNT327 indicated single-agent activity in 1L NSCLC with an ORR of 47%, DCR of 100%, and mPFS of 136 months[45] Financial Results - Total revenues for Q1 2025 were €183 million, compared to €188 million in Q1 2024[52] - Net loss for Q1 2025 was €416 million, compared to €315 million in Q1 2024, with a basic and diluted loss per share of €173 compared to €131[52] - Cash and cash equivalents plus security investments as of March 31, 2025, reached approximately €159 billion, comprising €101849 million cash and cash equivalents, €35420 million current security investments, and €21275 million non-current security investments[11, 52] - Planned FY 2025 total revenues are guided at €17 billion – €22 billion, with R&D expenses between €26 billion – €28 billion and SG&A expenses between €650 million – €750 million[53]