Black Diamond Therapeutics (BDTX) Stifel 2025 Virtual Targeted Oncology Forum summary

Company overview and recent partnership

• Developing oral therapies for oncology, with lead program 1535 targeting non-small cell lung cancer and glioblastoma.

• Recent deal with Servier for BDTX-4933, a RAS inhibitor, included $70M upfront and up to $710M in milestones plus royalties.

• Cash runway extended through Q4 2027, supporting advancement of 1535 into pivotal development.

Clinical landscape and lead asset differentiation

• Non-classical EGFR mutations (NCMs) represent about 25% of EGFR mutant NSCLC, a market larger than exon 20.

• Current treatments for NCMs lack a standard of care; most patients receive chemotherapy, afatinib, or osimertinib, with short duration of benefit.

• 1535 is a fourth-generation TKI designed for broad activity across NCMs, sparing wild type, and is brain penetrant.

Development strategy and clinical progress

• Focus shifted to frontline NCM patients due to competitive landscape and patient preference for oral therapies.

• Phase 2 recurrent cohort enrollment complete; final data expected in H1 next year.

• Frontline cohort to enroll 40 patients by H2 2024, with data and FDA feedback to be disclosed together in Q4 2024.