Black Diamond Therapeutics (BDTX) Stifel 2024 Healthcare Conference summary

Program progress and clinical data

• Lead program BDTX-1535 advanced as a fourth-generation EGFR inhibitor for non-small cell lung cancer, showing activity across a broad spectrum of mutations and achieving a 30%-40% response rate in phase 2.

• Dose established at 200 mg, with about 20% of patients requiring reduction to 150 mg, primarily due to rash.

• Phase 2 enrolled patients mainly in the recurrent setting post-osimertinib, with two cohorts: non-classical mutations and C797S resistance mutation.

• Longest confirmed response at data cutoff was nine months, with most responses expected to confirm, especially in frontline settings.

• Safety profile is more similar to osimertinib than afatinib, with slightly higher rash but less diarrhea and minimal grade 3 events.

Strategic decisions and development plans

• October restructuring deprioritized the pan-RAF inhibitor (4933) to extend financial runway and focus on BDTX-1535.

• Ongoing enrollment for phase 2 second-line cohort, targeting 80 patients with two scans each, aiming for a comprehensive data update in Q1 2025.

• Frontline cohort enrolling a wide array of non-classical mutations, with a goal to present data on about 20 patients with two scans in 2025.

• Regulatory strategy anticipates a randomized trial as the base case for registration, with potential for a single-arm approach if data are compelling.

• Enrollment criteria for current trials remain unchanged, but will be revised for future studies.

Market opportunity and financial outlook

• Addressable population estimated at 8,000 G7 patients post-osimertinib (second-line) and 20,000 G7 patients in frontline non-classical EGFR mutant NSCLC.

• Combined opportunities, including adjuvant and L858R, could reach 40,000 patients, representing a potential $2 billion+ market.

• Cash runway extends into mid-2026, supporting ongoing and planned studies.