BioNTech (BNTX): Updated Gotistobart OS Data Continues to Derisk Program; Watching Novel/Novel Data Next

This morning at the World Conference on Lung Cancer, BioNTech reported the first median overall survival data from stage 1 of the global randomized PRESERVE-003 Phase 3 study of gotistobart (CTLA-4 antibody) in 2L+ sqNSCLC vs docetaxel — median OS 18.5 months vs 10.0 months (HR 0.56; nominal p=0.0295). While the HR deteriorated slightly from the last data cut (0.56 vs prior 0.46), we view the updated profile as still very strong and as a positive, meaningful de-risking ahead of the pivotal stage 2 interim readout expected near YE26. We model peak risk-adjusted sales of €926mn for the program at a 50% PoS, and fully derisking it leads to ~10% upside to our DCF. Separately, Akeso's ivonescimab HARMONi-2 (China-only) OS data (30.8 vs 22.6 months, HR=0.73) provides favorable read-across to BNTX/BMY's pumitamig. We continue to see a catalyst-rich period ahead, including tomorrow's WCLC oral presentation of the pumitamig + Elfe-D novel-novel combination and upcoming BNT116/BNT113 mRNA immuno