On August 7, 2025 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 second quarter ended June 30, 2025, and provided a corporate update (Press release, Black Diamond Therapeutics, AUG 7, 2025, View Source [SID1234654963]).

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"With enrollment completed in our silevertinib Phase 2 trial for the treatment of newly diagnosed patients with EGFRm NSCLC, we look forward to sharing a clinical update in the fourth quarter of 2025," said Mark Velleca, M.D., Ph.D., President and Chief Executive Officer of Black Diamond Therapeutics. "Given the evolving competitive and regulatory landscape, we are also exploring partnership opportunities to advance silevertinib into pivotal development and bring this potential best-in-class treatment to patients as quickly as possible."

Recent Developments & Upcoming Milestones:

Silevertinib (BDTX-1535):

In July 2025, Black Diamond completed enrollment (n=43) in the Phase 2 trial of silevertinib in frontline non-small cell lung cancer (NSCLC) patients with non-classical EGFR mutations.
In the fourth quarter of 2025, Black Diamond expects to disclose objective response rate (ORR) and preliminary duration of response (DOR) data from all patients (n=43) in the Phase 2 trial of silevertinib in frontline NSCLC with non-classical EGFR mutations.
Black Diamond is exploring partnership opportunities in NSCLC and glioblastoma (GBM) to advance silevertinib into pivotal development.
The Company plans to solicit U.S. Food and Drug Administration (FDA) feedback on a potential registrational path in frontline EGFRm NSCLC in 1H 2026, when progression free survival (PFS) data from the ongoing Phase 2 trial becomes available.

Financial Highlights

Cash Position: Black Diamond ended the second quarter of 2025 with approximately $142.8 million in cash, cash equivalents, and investments compared to $98.6 million as of December 31, 2024. Net cash used in operations was $9.2 million for the second quarter of 2025 compared to net cash used in operations of $14.7 million for the second quarter of 2024.
Research and Development Expenses: Research and development (R&D) expenses were $9.3 million for the second quarter of 2025, compared to $12.6 million for the same period in 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 $4.1 million for the second quarter of 2025, compared to $9.6 million for the same period in 2024. The decrease in G&A expenses was primarily due to the restructuring announced in October 2024.
Net Income/Loss: Net loss for the second quarter of 2025 was $10.6 million, as compared to a net loss of $19.9 million for the same period in 2024.

Financial Guidance

Black Diamond ended the second quarter of 2025 with approximately $142.8 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 fourth quarter of 2027.