Black Diamond Therapeutics, Inc. (BDTX), reported first-quarter 2026 financial results and provided a corporate update, underscoring continued progress across its MasterKey oncology pipeline, led by its fourth-generation EGFR inhibitor Silevertinib.
The company is advancing Silevertinib across multiple tumors types, including EGFR-mutant non-small cell lung cancer (NSCLC) and EGFRvIII-positive glioblastoma (GBM), with several clinical readouts expected this year.
For the first quarter of 2026, Black Diamond reported a net loss of $9.0 million, compared with net income of $56.5 million in the same period last year. The year-over-year change reflects the absence of $70 million in license revenue recorded in Q1 2025.
Research and development expenses declined to $7.0 million from $10.5 million a year earlier, driven by the progression of the Phase 2 Silevertinib program and the out-licensing of BDTX-4933. General and administrative expenses fell to $4.3 million from $5.0 million in Q1 2025.
Black Diamond ended the quarter with $118.3 million in cash, cash equivalents, and investments, which the company expects will fund operations into the second half of 2028.
Pipeline and Clinical Program Updates
Silevertinib (EGFR MasterKey Inhibitor)
Silevertinib is Black Diamond's lead program, a brain-penetrant, fourth-generation EGFR inhibitor designed to target a broad family of oncogenic EGFR mutations while minimizing wild-type toxicity. The program is advancing across multiple Phase 2 studies in NSCLC and GBM.
Key updates include:
-An oral presentation of Phase 2 data in frontline EGFR-mutant NSCLC, including preliminary duration of response (DOR) and progression-free survival (PFS), will be delivered at the 2026 ASCO Annual Meeting.
-A poster presentation will highlight Phase 2 data in recurrent EGFR-mutant NSCLC.
-A trial-in-progress poster will detail the randomized Phase 2 study in newly diagnosed EGFRvIII-positive GBM.
-The first patient has been dosed in the Phase 2 GBM trial evaluating Silevertinib in combination with Temozolomide (TMZ).
BDTX-4933 (RAF/RAS Program- Out-licensed)
BDTX-4933, a RAF/RAS-mutant solid tumor program, has been licensed to Servier, a global independent pharmaceutical company headquartered in France, allowing Black Diamond to focus resources on Silevertinib.
BDTX has traded between $1.53 and $4.94 over the past year. The stock is currently trading at $2.56, down 9.04%.
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