Black Diamond Therapeutics Earnings Call Transcripts
Fiscal Year 2026
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Silevertinib, a fourth-generation EGFR inhibitor, shows strong efficacy and CNS activity in non-classical EGFR NSCLC and is advancing into a pivotal GBM trial. Key PFS data in NSCLC are expected in Q2 2024, with GBM trial enrollment starting soon and results anticipated in 2028.
Fiscal Year 2025
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Silevertinib’s Phase II data in non-classical EGFR-mutant lung cancer showed a 60% response rate and strong CNS activity, with durability and PFS data expected in Q2 2026. Plans include FDA engagement, a pivotal trial, and a Phase II GBM study, supported by a strong financial runway.
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Silevertinib demonstrated a 60% response rate and robust CNS activity in frontline NSCLC patients with non-classical EGFR mutations, with efficacy maintained after dose reductions. A randomized phase II trial in newly diagnosed GBM patients with EGFR variant 3 will launch, focusing on high unmet need and leveraging silevertinib's strong brain penetrance.
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Silevertinib is advancing as a brain-penetrant EGFR inhibitor for non-small cell lung cancer and glioblastoma, targeting a broad range of mutations with promising early efficacy and tolerability. Key data updates and partnership decisions are expected in the coming quarters.
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Silevertinib, a brain-penetrant EGFR inhibitor, is advancing in phase 2 for non-classical EGFR-mutant lung cancer and glioblastoma, with key data expected this quarter. The drug targets a broad mutation spectrum, with a $2B+ market opportunity and pivotal phase 3 planned next year.
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A fourth-generation EGFR TKI is advancing in phase II for frontline non-small cell lung cancer, targeting non-classical mutations with strong CNS activity and a favorable safety profile. A pivotal phase III trial is planned, with accelerated approval possible by 2029. Key data readouts and regulatory updates are expected later this year.
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The company is advancing its lead oral therapy, 1535, for non-classical EGFR mutant NSCLC, with a focus on frontline patients and broad mutation coverage. A recent partnership has extended cash runway, enabling pivotal development and a Q4 2024 data and FDA update.
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BDTX-1535, an oral fourth-generation EGFR inhibitor, is advancing in NSCLC and GBM with broad activity across mutation types and a favorable safety profile. Key phase II data in frontline NSCLC and regulatory updates are expected in Q4 2024, with additional GBM data in 2025.
Fiscal Year 2024
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A fourth-generation EGFR inhibitor is advancing through phase 2 trials, showing robust efficacy and favorable tolerability in both recurrent and frontline non-small cell lung cancer, especially for non-classical and resistant mutations. Regulatory updates and mature data are expected in 1Q25.
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BDTX-1535 demonstrated promising activity and tolerability in phase 2 for non-small cell lung cancer, with a 30%-40% response rate and a manageable safety profile. Strategic focus and financial runway support pivotal development, with key data updates expected in 2025.
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Initial Phase II data for BDTX-1535 in recurrent EGFR-mutated NSCLC show a 42% response rate at 200 mg, with durable responses and a favorable safety profile. Activity was observed across diverse resistance mutations, supporting further development in both recurrent and frontline settings.