Black Diamond Therapeutics (BDTX) investor relations material

Key program updates and clinical data

• Released first Phase II data for Silevertinib in frontline lung cancer with non-classical EGFR mutations, showing a 60% response rate across 35 mutation types and strong CNS activity, with 86% brain response rate among patients with measurable brain metastases.

• Durability of response and progression-free survival (PFS) data are expected in Q2 2026, which will be critical for regulatory and partnership discussions.

• Silevertinib is positioned as a fourth-generation EGFR TKI with broad coverage of non-classical mutations and high brain penetrance, differentiating it from existing therapies.

• Adverse event profile is manageable, with dose reductions not compromising efficacy; some patients continue therapy post-progression due to perceived benefit.

• Plans to engage with the FDA in H1 2025 to align on pivotal trial design, likely a randomized study with PFS and OS endpoints; comparator arm selection remains a key variable.

Market opportunity and partnership strategy

• Silevertinib targets a quarter of the EGFR lung cancer segment, representing a potential $2 billion market opportunity in the frontline setting.

• Actively seeking a global partner, especially with an Asian footprint, to support large Phase III trials while preserving shareholder value; timing of partnership may align with or follow FDA discussions.

• Partnership structures may allow for shared development, with potential for the company to retain GBM program leadership and value.

Glioblastoma program and trial design

• Advancing Silevertinib into a Phase II trial for newly diagnosed glioblastoma, leveraging its potent activity against EGFRvIII and high brain penetrance.

• Phase II GBM trial will randomize 75 patients per arm to standard of care (temozolomide) versus temozolomide plus Silevertinib, with PFS as the primary endpoint and initial data expected in H1 2028.

• Strong feedback from key opinion leaders at recent neuro-oncology conferences, with enthusiasm for the drug’s brain penetrance and potential to address an unmet need.