Black Diamond Therapeutics, Inc.

What they do

Black Diamond discovers oral small molecule MasterKey inhibitors designed to target families of oncogenic mutations sharing a common activating conformation, using its MAP drug discovery engine. Its lead candidate, silevertinib (formerly BDTX-1535), is an irreversible, fourth-generation, brain-penetrant EGFR inhibitor being studied in a Phase 2 trial in EGFRm NSCLC and in a Phase 2 trial in newly diagnosed EGFRvIII+ glioblastoma. The pipeline also includes BDTX-4933, a clinical-stage candidate licensed to Servier Pharmaceuticals, and BDTX-4876, a development-stage candidate for which the company is evaluating strategic alternatives. The company is not currently commercializing any product and has recorded no quarterly product revenue in the periods shown.

Revenue drivers

• Silevertinib (lead clinical program) — Pre-revenue; potential future value depends on clinical success and regulatory approval in EGFRm NSCLC and EGFR-altered GBM. The company reported no revenue in the quarters ended September 30, 2025 through June 30, 2026.
• BDTX-4933 (Servier partnership) — Outlicensed clinical-stage RAF/RAS-mutant solid tumor candidate being developed by Servier, which could generate development and commercial milestone payments plus tiered royalties on global net sales, if achieved.
• BDTX-4876 — Development-stage product candidate for which the company is evaluating strategic alternatives; no revenue contribution disclosed.

Recent performance

At ASCO in May 2026, the company presented Phase 2 data in 43 frontline EGFR non-classical mutant NSCLC patients dosed at 200 mg QD: ORR by RECIST 1.1 of 60%, CNS ORR by RANO-BM of 86%, DCR of 91%, and preliminary median PFS of 15.2 months at a median follow-up of 11.2 months. Median duration of response had not been reached, no patients developed de novo brain metastases, and 23 of 43 patients (53%) remained on therapy with the longest at 23.5 months. The company reported a second quarter 2026 cash, cash equivalents and investments balance of approximately $110.5 million versus $128.7 million at December 31, 2025, with net cash used in operations of $8.0 million. R&D expenses were $7.4 million for the second quarter of 2026 compared with $9.3 million for the same period in 2025.

Strategy

The company plans to advance silevertinib toward pivotal development in frontline non-classical EGFRm NSCLC, selecting a 150 mg QD dose based on pooled safety, pharmacokinetics, pharmacodynamics and efficacy data, and is seeking FDA feedback on a pivotal path. For GBM, it initiated a randomized Phase 2 trial of silevertinib in combination with temozolomide in newly diagnosed EGFRvIII+ GBM, with the first patient dosed in May 2026, and remains on track to initiate the randomized portion in the fourth quarter of 2026. It continues to rely on Servier to develop and commercialize BDTX-4933 and is evaluating strategic alternatives for BDTX-4876. Management states the current cash position is expected to fund operations into the second half of 2028.

Risks

• Dependence on a single lead candidate — The company is substantially dependent on silevertinib, which is still in Phase 2 and has not received regulatory approval for any indication.
• No product revenue — The company generated $0 revenue in each of the quarters from September 30, 2025 through June 30, 2026 and does not expect product revenue for many years, if ever.
• Clinical and regulatory uncertainty — Success depends on completing clinical trials, obtaining FDA acceptance of its development strategy, and ultimately gaining approval for silevertinib or future candidates.
• Partner and pipeline execution — BDTX-4933 depends on Servier's development and commercialization efforts, and BDTX-4876 depends on the outcome of strategic alternatives the company is still evaluating.

Outlook

Management expects to provide an update on the Phase 2 trial of silevertinib in frontline non-classical EGFRm NSCLC and an update on FDA feedback regarding a pivotal development path in the fourth quarter of 2026. The company remains on track to initiate the randomized portion of the Phase 2 trial in newly diagnosed EGFRvIII+ GBM in the fourth quarter of 2026. It also states that its $110.5 million cash, cash equivalents and investments as of June 30, 2026 are expected to fund operations into the second half of 2028.