Quarterly ResultAug 5, 2026, 04:04 PM
Black Diamond Therapeutics Reports Positive Silevertinib Phase 2 Results
AI Summary
Black Diamond Therapeutics reported positive Phase 2 results for silevertinib in frontline patients with non-classical EGFRm NSCLC, highlighting no de novo brain metastases and an 86% CNS objective response rate in patients with baseline brain metastases. The company anticipates FDA feedback on a pivotal development path for silevertinib in Q4 2026. Financially, Black Diamond ended Q2 2026 with $110.5 million in cash, cash equivalents, and investments, sufficient to fund operations into the second half of 2028, and reported a net loss of $9.9 million for the quarter.
Key Highlights
- Presented positive Phase 2 results for silevertinib in non-classical EGFRm NSCLC at 2026 ASCO Annual Meeting.
- No patients developed de novo brain metastases; CNS objective response rate was 86% in patients with baseline brain metastases.
- Anticipates FDA feedback on pivotal development path for silevertinib in frontline NSCLC in Q4 2026.
- Cash, cash equivalents, and investments totaled $110.5 million as of June 30, 2026.
- Cash runway expected to fund operations into the second half of 2028.
- Net loss for Q2 2026 was $9.9 million, compared to $10.6 million for Q2 2025.
- Research and development expenses decreased to $7.4 million for Q2 2026.
Price Impact
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