Black Diamond Therapeutics (BDTX) Q1 2026 earnings summary

Executive summary

• Lead program silevertinib advanced in Phase 2 trials for NSCLC and GBM, with promising efficacy and safety data, including high CNS response rates and favorable tolerability profile as of November 2025.

• Oral presentation of silevertinib Phase 2 data in frontline EGFRm NSCLC patients scheduled for the 2026 ASCO Annual Meeting, including preliminary DOR and PFS data.

• First patient dosed in the Phase 2 trial of silevertinib in newly diagnosed EGFRvIII+ GBM in May 2026.

• BDTX-4933 outlicensed to Servier in Q1 2025, with $70M upfront received and eligibility for up to $710M in milestones and tiered royalties.

• Focus remains on advancing silevertinib into pivotal development for NSCLC and GBM indications.

Financial highlights

• Cash, cash equivalents, and investments totaled $118.3M as of March 31, 2026, down from $128.7M at year-end 2025.

• Net loss of $9.0M for Q1 2026, compared to net income of $56.5M in Q1 2025, reflecting absence of one-time license revenue.

• No revenue recognized in Q1 2026; $70M license revenue recognized in Q1 2025 from Servier agreement.

• Net cash used in operations was $10.2M in Q1 2026; cash provided by operations was $53.4M in Q1 2025.

• Research and development expenses decreased to $7.0M in Q1 2026 from $10.5M in Q1 2025, mainly due to lower silevertinib NSCLC trial costs and BDTX-4933 deprioritization.

Outlook and guidance

• Cash runway projected into the second half of 2028 based on current plans and assumptions.

• Additional capital will be required to support future growth, regulatory approvals, and potential commercialization.

• Continued advancement of silevertinib in ongoing Phase 2 trials for NSCLC and GBM, with clinical updates anticipated at major conferences.

• Ongoing evaluation of partnership opportunities for silevertinib pivotal development.