Black Diamond Therapeutics (BDTX) Piper Sandler 36th Annual Healthcare Conference summary

Program overview and development focus

• Advancing a fourth-generation EGFR inhibitor for non-small cell lung cancer and glioblastoma, currently in phase 2 trials with additional data expected in 2025.

• Designed for broad mutation coverage, CNS penetrance, and a wide therapeutic window for improved tolerability and safety.

• Targeting both recurrent and frontline settings, with a focus on non-classical and drug-resistant EGFR mutations.

• Emphasizing once-daily oral dosing and favorable side effect profile compared to competitors.

Clinical data highlights and patient outcomes

• September phase 2 data showed robust response rates and favorable tolerability, with no discontinuations due to EGFR toxicities.

• Similar response rates observed in non-classical and C797S resistance mutation cohorts.

• Most patients with radiographic progression remained on therapy due to symptom improvement and disease control.

• 200 mg dose selected for future use based on superior efficacy and tolerability over 100 mg.

• Full data set of 80 patients (20 at 100 mg, 60 at 200 mg) expected in 2025.

Regulatory strategy and future milestones

• Fast Track designation for C797S mutation; ongoing FDA discussions on non-classical mutation definitions and unmet need.

• Planning regulatory update and mature data release in 1Q25, with focus on both recurrent and frontline opportunities.

• Exploring accelerated approval paths, including single-arm or randomized studies, depending on data strength.

• Grouping diverse mutations into structure-function classes to support a broad label.