Black Diamond Therapeutics (BDTX) Corporate presentation summary

Company overview and strategy

• Focuses on developing MasterKey therapies to target families of oncogenic mutations, expanding the addressable patient population in cancer treatment.

• Pipeline includes oral, brain-penetrant drug candidates with silevertinib as the lead asset in advanced clinical trials for NSCLC and GBM.

• Employs a lean organization with a cash runway into the second half of 2028, ending Q1 2026 with $118.3M.

• Experienced team with deep expertise in cancer biology and oncology drug development.

Silevertinib clinical development and efficacy

• Silevertinib is a potential first- and best-in-class 4th generation EGFR TKI, showing robust anti-tumor activity and CNS penetration.

• Achieved 60% ORR and 15.2 months mPFS in frontline NSCLC with non-classical EGFR mutations; 86% CNS ORR.

• Demonstrates broad potency against over 50 unique EGFR mutations, including resistance mutations, and spares wild-type EGFR for better tolerability.

• Phase 2 data in NSCLC to be presented at ASCO 2026, with FDA feedback on pivotal development expected in H2 2026.

Market opportunity and competitive positioning

• Silevertinib targets ~25% of newly diagnosed 1L EGFRm NSCLC patients and ~50% of 1L EGFRm GBM patients.

• Estimated $2bn+ opportunity in 1L non-classical EGFRm NSCLC and EGFR+ GBM, with potential expansion to other populations.

• Eligible for up to $710M in milestones and royalties from partnered assets.