On March 16, 2026 Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with cancer, reported financial results for the fourth quarter and full year ended December 31, 2025, and provided a corporate update.

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"We continue to focus on advancing silevertinib for the treatment of patients with EGFRm NSCLC and EGFR altered GBM," said Mark Velleca, M.D., Ph.D., President and Chief Executive Officer of Black Diamond Therapeutics. "We look forward to presenting updated results from the Phase 2 NSCLC trial in both the frontline and recurrent settings, including preliminary DOR and PFS data for frontline patients, at a medical meeting in the second quarter of 2026. We also expect to initiate our randomized Phase 2 trial in newly diagnosed GBM in the second quarter this year."

Recent Developments & Upcoming Milestones:

In December 2025 the Company disclosed initial data from the Phase 2 trial of silevertinib in frontline non-small cell lung cancer (NSCLC) patients harboring a broad spectrum of non-classical epidermal growth factor receptor (EGFR) mutations which demonstrated a 60% Objective Response Rate (ORR by RECIST 1.1), 86% CNS ORR (by RANO-BM) and 91% disease control rate (DCR) as of a November 3, 2025 data cutoff. No new safety signals were observed. Black Diamond continues to explore potential partnership opportunities to advance silevertinib into pivotal development.
Black Diamond anticipates the following upcoming key milestones for silevertinib:
Presentation of updated clinical data from our Phase 2 trial in patients with non-classical EGFR NSCLC in both the recurrent setting and the frontline setting, including preliminary duration of response (DOR) and progression-free survival (PFS) data for frontline EGFRm patients, at a medical meeting in the second quarter of 2026 (NCT05256290).
Initiation of a randomized Phase 2 trial in patients with newly diagnosed EGFR-altered GBM in the second quarter of 2026 (NCT07326566).
Financial Highlights

Cash Position: Black Diamond ended 2025 with approximately $128.7 million in cash, cash equivalents, and investments compared to $98.6 million as of December 31, 2024. Net cash provided by operations was $29.6 million for the year ended December 31, 2025 compared to net cash used in operations of $62.3 million for the year ended December 31, 2024.
Research and Development Expenses: Research and development (R&D) expenses were $6.3 million for the fourth quarter of 2025, compared to $12.3 million for the same period in 2024. R&D expenses were $33.6 million for the year ended December 31, 2025, compared to $51.3 million for the year ended December 31, 2024. The decrease in R&D expenses was primarily due to workforce efficiencies and outlicensing of BDTX-4933 to increase focus on the development of silevertinib.
General and Administrative Expenses: General and administrative (G&A) expenses were $4.0 million for the fourth quarter of 2025, compared to $6.0 million for the same period in 2024, and $16.6 million for the year ended December 31, 2025, compared to $27.5 million for the year ended December 31, 2024. The decrease in G&A expenses was primarily due operational and workforce efficiencies from the restructuring announced in October 2024.
Net Loss: Net loss for the fourth quarter of 2025 was $15.1 million, as compared to $16.0 million for the same period in 2024. Net income for the year ended December 31, 2025 was $22.4 million compared to a net loss of $69.7 million for the year ended December 31, 2024.
Financial Guidance

Black Diamond ended 2025 with approximately $128.7 million in cash, cash equivalents and investments which the Company believes is sufficient to fund its anticipated operating expenses and capital expenditure requirements into the second half of 2028.

(Press release, Black Diamond Therapeutics, MAR 16, 2026, View Source [SID1234663560])