Black Diamond Therapeutics (BDTX) 24th Annual Needham Virtual Healthcare Conference summary

Corporate and pipeline overview

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

• Anticipates multiple clinical updates for BDTX-1535 in 2025 and 2026, with cash runway into Q4 2027.

• BDTX-4933, a RAF/RAS inhibitor, transitioned to Servier with $70M upfront and up to $710M in milestones plus royalties.

• Early-stage FGFR program seeking partners.

Clinical data and development plans

• BDTX-1535 shows robust phase II data in recurrent NSCLC; initial phase II data in newly diagnosed NSCLC expected Q4 2024.

• Phase I and II trials demonstrate broad activity across classical, non-classical, and C797S EGFR mutations.

• Well-tolerated safety profile with mostly grade 1/2 adverse events and minimal dose reductions.

• Phase II trial includes three cohorts: post-osimertinib NCM, C797S, and frontline NCM patients.

• Frontline phase II data and regulatory update expected Q4 2024; final recurrent NSCLC data in 1H 2025.

Market landscape and competitive positioning

• BDTX-1535 targets a large unmet need in NSCLC, especially for non-classical mutations, which comprise 23–30% of EGFR-mutant cases.

• Current standard osimertinib is less effective for NCMs; 1535 offers broader coverage and brain penetrance.

• Competitors include third-generation inhibitors and agents focused on exon 20, but 1535 uniquely covers classical, non-classical, and C797S mutations.

• Estimated addressable market for NCMs is about one quarter of the osimertinib market.