secwatch.observer — SEC 8-K summary
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Issuer:     Black Diamond Therapeutics, Inc. (BDTX)
CIK:        0001701541
Form:       8-K
Filed at:   2025-12-03T23:59:59+00:00
Accession:  0001104659-25-117975
Event type: other_material
Sentiment:  positive
Materiality: 0.80
Item codes: 2.02, 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Black Diamond reports 60% ORR for silevertinib in 1L NSCLC; plans Phase 2 GBM trial; cash into 2H 2028
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- 60% ORR (26/43) in 1L NSCLC with 35 distinct non-classical EGFR mutations; 86% CNS ORR in patients with brain metastases.
- No new safety signals; AEs managed with supportive care; 29/43 patients remain on therapy, longest >19 months.
- Plans randomized Phase 2 trial of silevertinib+TMZ in ~150 ND GBM patients, initiated 1H 2026, preliminary data expected 2028.
- Cash $135.5M as of Sep 30, 2025, now expected to fund operations into 2H 2028; partner assumed for NSCLC pivotal.
- PFS and DOR data for NSCLC (recurrent and frontline) expected at medical meeting in Q2 2026.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1701541/000110465925117975/0001104659-25-117975-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1701541/000110465925117975/tm2532577d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-25-117975

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer