Black Diamond Therapeutics Reports Updated Phase 2 Silevertinib Data, FDA End-Of-Phase 2 Feedback, Supporting Pivotal Development In All 1L EGFR-NCM NSCLC Patients With Potential For Accelerated Approval Based On CNS-ORR

• Updated Phase 2 results demonstrate robust CNS activity, including 86% CNS-ORR and mPFS double that of currently available EGFR TKIs, in patients with untreated brain metastases
• Recent End-of-Phase 2 meeting with the FDA supports pivotal development in all 1L EGFR-NCM NSCLC patients with potential for accelerated approval based on CNS-ORR
• Cash, cash equivalents, and investments of $102.0 million as of September 30, 2026, is expected to be sufficient to fund operations into the second half of 2028
• Company to host an investor call today at 7:30am ET and will also participate in a fireside chat at the Stifel 2026 Healthcare Conference at 3:20pm ET

Black Diamond Therapeutics, Inc. (NASDAQ:BDTX), a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with cancer, including silevertinib, a potential best-in-class brain-penetrant epidermal growth factor receptor (EGFR) inhibitor, today reported updated data from its Phase 2 trial of silevertinib in frontline non-small cell lung cancer (NSCLC) patients with EGFR non-classical mutations (NCMs), the outcome from its End of Phase 2 meeting with the U.S. Food and Drug Administration (FDA) and associated Phase 3 plans, and financial results for the third quarter ended September 30, 2026.