BDTX - Earnings announcements

Silevertinib delivers robust anti-tumor activity as demonstrated by an ORR of 60% and a CNS response rate of 86% in 43 1L NSCLC patients presenting with 35 different non-classical EGFR mutations; no new safety signals observed to datePFS data for 1L NSCLC patients expected in Q2 2026; Company continues to explore partnership opportunities for pivotal development of silevertinibBased on encouraging CNS activity of silevertinib in multiple trials across NSCLC and GBM, Company plans to initiate a randomized Phase 2 trial of silevertinib in newly diagnosed GBM patients in 1H 2026; initial data anticipated in 2028Cash, cash equivalents, and investments of $135.5 million as of September 30, 2025;

BDTX-1535, an epidermal growth factor receptor (EGFR) MasterKey inhibitor, demonstrates clinical proof of activity for MasterKey mutation-targeting approach based on radiographic tumor responses and circulating tumor DNA changes in NSCLC patients with acquired resistance and intrinsic driver EGFR mutations Confirmed radiographic partial response by RECIST 1.1 achieved across predicted therapeutic doses in 5 of 12 NSCLC patients in subgroup with measurable disease, who underwent post baseline tumor assessment by RECIST1.1; one additional patient demonstrated unconfirmed PR awaiting confirmation, while the remaining six patients had stable diseaseExpansion cohorts expected to commence i