BioNTech (BNTX) investor relations material

Pipeline overview and program updates

• Over 20 ongoing phase 2 and 3 oncology trials, with 30+ novel combination cohorts across multiple tumor types, reflecting a robust, diversified late-stage pipeline spanning IO, ADCs, and mRNA vaccines.

• Pipeline anchored by pomitamic/pumitamig as a pan-tumor backbone, expanding into new indications like CRC and gastric cancer, and including immunomodulators, ADCs, mRNA immunotherapies, and individualized neoantigen-specific therapies across solid tumors, breast, lung, GI, GU, and gynecologic cancers.

• ADC portfolio includes HER2, TROP2, B7H3, HER3, CA99, and BNT324/DB-1311, targeting diverse tumor types and stages.

• Broad disease area strategy enabled by a modular pipeline and a shift to later-stage, de-risked programs, with a disease area-specific approach planned for 2026.

• Key partnerships with Bristol Myers Squibb, DualityBio, MediLink, Genentech, and OncoC4 support pipeline breadth and depth.

Clinical trial data and development milestones

• Pomitamic/pumitamig is in registrational trials for NSCLC, SCLC, TNBC, CRC, and gastric cancer, showing efficacy across PD-L1 statuses and in combination with chemotherapy and ADCs.

• Gotistobart, an anti-CTLA-4 antibody, is advancing in phase 3 for 2L squamous NSCLC, with data expected at NACLC in December 2025.

• ADCs such as trastuzumab pamirtecan and BNT324/DB-1311 have demonstrated encouraging activity in HER2- and B7-H3-expressing tumors, with dose-finding and proof-of-concept studies underway.

• mRNA immunotherapies (BNT111, FixVac, iNeST) are being evaluated in randomized trials, with autogene cevumeran showing robust, durable T-cell responses in melanoma and CRC.

• Multiple pivotal and proof-of-concept trials are ongoing or planned, with key data readouts expected in 2025 and 2026.

R&D strategy and innovation priorities

• Focus on next-generation IOs, highly precise ADCs, and combination therapies, with a three-wave strategy: foundational trials, expansion into new indications, and novel combinations.

• Emphasis on synergy between IO, ADCs, and mRNA for personalized and off-the-shelf therapies, leveraging full AI integration and in-house manufacturing for rapid, personalized drug development.

• Ongoing optimization of antigen selection algorithms for individualized vaccines, leveraging AI and clinical data.

• Portfolio management prioritizes high-probability, late-stage assets while maintaining investment in high-risk, high-reward programs.