BioNTech Provides Business and Pipeline Updates at 43rd Annual J.P. Morgan Healthcare Conference

Strategic Priorities and Pipeline Updates - BioNTech aims to become a global immunotherapy powerhouse, focusing on innovative oncology products and prophylactic vaccines against infectious diseases [4] - The company is advancing its mRNA-based cancer immunotherapies and anti-PD-L1/-VEGF-A bispecific antibody candidate BNT327/PM8002 for treating advanced cancers [4] - Key data updates and global clinical trial starts are planned for 2025 across its oncology pipeline [4] Clinical Trials and Development Progress - BioNTech initiated a global randomized Phase 3 trial (NCT06712355) in December 2024 evaluating BNT327/PM8002 plus chemotherapy for first-line extensive-stage small cell lung cancer (ES-SCLC) [6] - A global randomized Phase 2/3 trial (NCT06712316) was initiated in December 2024 for BNT327/PM8002 plus chemotherapy in first-line non-small cell lung cancer (NSCLC) [6] - A Phase 3 trial for BNT327/PM8002 in first-line triple-negative breast cancer (TNBC) is on track to start in 2025 [6] - Additional clinical trials exploring novel combinations of BNT327/PM8002 with antibody-drug conjugates (ADCs) are planned for 2025 [6] mRNA Cancer Immunotherapy and ADC Candidates - Autogene cevumeran (BNT122/RO7198457), an mRNA cancer immunotherapy, is being developed in collaboration with Genentech [7] - BNT323/DB-1303, a HER2-targeted ADC, is being developed in collaboration with DualityBio [7] - The company plans to present clinical data from ongoing Phase 1/2a trials for BNT323/DB-1303 in HER2-expressing advanced endometrial cancer in 2025 [1] COVID-19 Vaccine and Market Expectations - BioNTech and Pfizer expect stable vaccination rates and market share in the U.S. for 2025, with revenue phasing similar to 2024 [1] - Advanced purchase agreements remain in place outside the U.S., including in the European Union [1] - The companies continue to invest in next-generation and combination COVID-19 vaccine candidates [1] Financial and Corporate Updates - Full-year and fourth-quarter 2024 financial results will be announced on March 10, 2025 [1] - The Annual General Meeting is scheduled for May 16, 2025 [1] - BioNTech will present its 2025 strategic priorities and pipeline updates at the 43rd Annual J.P. Morgan Healthcare Conference on January 14, 2025 [3]