Key Highlights

  • Third quarter net loss was USD 10.0 million, or USD 0.17 per share, against an estimated loss of USD 0.09.
  • Frontline lung cancer patients on silevertinib showed median progression-free survival of 15.0 months and a 60% response rate.
  • After an FDA end-of-phase 2 meeting, the company plans a Phase 3 trial of about 300 patients in 2027.
  • Cash and investments totaled USD 102.0 million at September 30, with management noting substantial additional Capital is required.

Black Diamond Therapeutics (NASDAQ:BDTX), a clinical-stage oncology company, reported a third quarter 2026 net loss of USD 10.0 million, or USD 0.17 per share, compared with an estimated loss of USD 0.09 and a loss of USD 0.15 in the same quarter last year. The company reported no Revenue in the period, while the supplied estimate called for USD 8.3 million. In the 2025 nine-month period it had recognized USD 70.0 million of license revenue, which has not recurred.

Total operating expenses were USD 12.1 million, up from USD 11.0 million. Research and Development spending was USD 7.0 million, down from USD 7.4 million, while general and administrative costs rose to USD 5.1 million from USD 3.5 million. Interest and other income contributed USD 2.1 million.

Frontline Data for Silevertinib

On November 10, the company released updated Phase 2 data for silevertinib, its brain-penetrant EGFR inhibitor, in frontline non-small cell lung cancer with non-classical EGFR mutations. As of an October 7 cutoff, 43 patients had been treated at 200 mg once daily, with median follow-up of 15.9 months. Median progression-free survival was 15.0 months, median duration of response was 13.8 months, the objective response rate was 60% and disease control reached 93%. Eighteen of the 43 patients, or 42%, remained on therapy.

Brain involvement was a focus. Among 24 patients without brain metastases at baseline, median progression-free survival was 23.5 months and none developed new brain metastases. In seven patients with untreated, measurable brain metastases, the central nervous system response rate was 86%, and four of nine patients with non-measurable lesions showed complete disappearance. Only 4 of 19 patients with baseline brain metastases had the brain as a site of progression.

On safety, the company reported no new signals. About 19% of patients discontinued because of adverse events, and after dose reductions the rate of grade 3 or higher treatment-related events fell to 28%. It selected 150 mg once daily for pivotal development and began a 20-patient cohort at that dose in the third quarter.

Phase 3 Design and Funding

At an October 1 end-of-phase 2 meeting, the FDA gave feedback on population, endpoints and dose. The company plans a global randomized Phase 3 trial of silevertinib at 150 mg against investigator's choice of afatinib or osimertinib in about 300 frontline patients with non-classical mutations and untreated brain metastases, with single-arm cohorts for patients without brain metastases and with leptomeningeal disease.

Central nervous system response rate would be the primary endpoint for a potential Accelerated Approval application, and progression-free survival for full approval. The company said safety data from enough patients at 150 mg must be submitted before opening the trial, with the start potentially in the second quarter of 2027, preliminary single-arm data anticipated in 2028 and response data in 2029.

At quarter end the company held USD 15.1 million in cash and USD 86.9 million in investments. Its filing states it must raise substantial additional capital to start and complete the Phase 3 program and to fund any commercialization. A randomized glioblastoma trial also dosed its first randomized patient in the fourth quarter.

Development and Capital Factors to Watch

Items to track include submission of the 150 mg cohort safety data, timing of the Phase 3 start, and the company's financing plans. The nine-month net loss was USD 29.0 million versus Net Income of USD 37.5 million a year earlier, which included the license revenue.