ORR and preliminary duration of treatment data for the Phase 2 trial of silevertinib in 1L patients with non-classical EGFRm NSCLC on track for this quarter Cash, cash equivalents, and investments of $135.5 million as of September 30, 2025; expected to be sufficient to fund operations into Q4 of 2027 CAMBRIDGE, Mass., Nov. 06, 2025 (GLOBE NEWSWIRE) -- Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations ...

Core Insights - Black Diamond Therapeutics, Inc. (BDTX) is focused on developing MasterKey therapies targeting oncogenic mutations in cancer patients, with its lead drug silevertinib being a fourth-generation EGFR MasterKey inhibitor for EGFRm non-small cell lung cancer (NSCLC) and glioblastoma (GBM) [1][10] Development and Pipeline - BDTX is currently conducting a phase II study of silevertinib in patients with EGFRm NSCLC, evaluating it in both recurrent and frontline settings, with FDA feedback anticipated in the first half of 2026 [2][10] - Following a global licensing agreement with Servier Pharmaceuticals for BDTX-4933, BDTX is now solely focused on silevertinib, making its pipeline dependent on the success of this single candidate [3][4][10] Competitive Landscape - The NSCLC market is highly competitive, dominated by major pharmaceutical companies such as AstraZeneca and Johnson & Johnson, with AstraZeneca's Tagrisso being a leading treatment option [5][6] - Johnson & Johnson's Rybrevant has recently gained FDA approval for first-line treatment in specific NSCLC patient populations, presenting additional competition for BDTX's silevertinib [7][8] Financial Performance - BDTX shares have increased by 75.7% year-to-date, significantly outperforming the industry average growth of 9.5% [9] - The company's shares are currently trading at a price/book ratio of 1.61x, which is lower than its historical mean of 1.31x and the biotech industry's average of 3.36x, indicating a potentially undervalued position [11]

Company Overview - Black Diamond Therapeutics, Inc. is a clinical-stage oncology company focused on developing MasterKey therapies that target families of oncogenic mutations in cancer patients [3] - The company's MasterKey therapies aim to address a wide range of genetically defined tumors, overcome resistance, minimize wild-type mediated toxicities, and penetrate the brain to treat central nervous system diseases [3] Upcoming Events - The CEO, Mark Velleca, M.D., Ph.D., will participate in a fireside chat at the Jefferies Global Healthcare Conference on June 4, 2025, in New York, NY [1] - The company will also host one-on-one meetings with investors on the same day [1] Product Development - Black Diamond Therapeutics is advancing a Phase 2 trial for BDTX-1535, which is a brain-penetrant fourth-generation epidermal growth factor receptor (EGFR) MasterKey inhibitor targeting EGFR-mutant non-small cell lung cancer (NSCLC) and glioblastoma [3]