On August 5, 2026 Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with cancer, including silevertinib, a potential best-in-class brain-penetrant epidermal growth factor receptor (EGFR) inhibitor, reported financial results for the second quarter ended June 30, 2026, and provided a corporate update.
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"Silevertinib continued to demonstrate robust clinical activity and durable responses in frontline patients with non-classical EGFR-mutant NSCLC, as presented at ASCO (Free ASCO Whitepaper) in May," said Mark Velleca, M.D., Ph.D., President and Chief Executive Officer of Black Diamond Therapeutics. "We are particularly encouraged that no patients developed de novo brain metastases and that the CNS ORR was 86% in patients with baseline brain metastases. Approximately 80% of all patients with non-classical EGFR mutations progress in the brain, and approximately 40% of patients with non-classical EGFR-mutant NSCLC present with brain metastases at diagnosis, underscoring silevertinib’s potential to address this significant unmet medical need. We look forward to engaging with the FDA and providing an update on the pivotal development path for silevertinib in frontline NSCLC in the fourth quarter."
Recent Developments & Upcoming Milestones:
•On May 30, 2026, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, data were presented from the Phase 2 trial of silevertinib dosed at 200 mg once daily (QD) in 43 frontline NSCLC patients harboring a broad spectrum of EGFR non-classical mutations, including compound and P-Loop and C-Helix Compressing (PACC) mutations. As of an April 11, 2026 data cutoff date, results were as follows:
◦Objective Response Rate (ORR by RECIST 1.1), CNS ORR (ORR by RANO-BM), and Disease Control Rate (DCR) were 60%, 86% and 91%, respectively
◦Variant allele frequency reduction observed in all evaluable patients across 25 unique EGFR non-classical mutations, including PACC
◦Median duration of response had not been reached (95% CI: 7.0, NE)
◦Preliminary median progression-free survival of 15.2 months (95% CI: 10.8, NE)
◦No patients developed de novo brain metastases
◦23 of 43 patients (53%) remained on therapy, with the longest at 23.5 months
◦No new safety signals were observed. The rate of treatment-related adverse events greater than or equal to Grade 3 was reduced to 28% following dose reduction, and patients maintained or deepened clinical responses after dose reduction.
◦Safety, pharmacokinetics, pharmacodynamics and efficacy data support a 150 mg QD dose for pivotal development
•The Company plans to provide an update on the Phase 2 trial of silevertinib in frontline patients with non-classical EGFR-mutant (EGFRm) NSCLC in the fourth quarter of 2026.
•The Company is seeking U.S. Food and Drug Administration (FDA) feedback on a pivotal development path for silevertinib in frontline patients with non-classical EGFRm NSCLC, and expects to provide an update in the fourth quarter of 2026.
•The Phase 2 trial of silevertinib in combination with temozolomide in newly diagnosed EGFRvIII+ glioblastoma (GBM) is enrolling patients in the safety lead-in portion of the study. The Company remains on track to initiate the randomized portion of the study in the fourth quarter of 2026.
Financial Highlights
•Cash Position: Black Diamond ended the second quarter of 2026 with approximately $110.5 million in cash, cash equivalents, and investments compared to $128.7 million as of December 31, 2025. Net cash used in operations was $8.0 million for the second quarter of 2026 compared to net cash used in operations of $9.2 million for the second quarter of 2025.
•Research and Development Expenses: Research and development (R&D) expenses were $7.4 million for the second quarter of 2026, compared to $9.3 million for the same period in 2025. The decrease in R&D expenses was primarily due to the progression of our Phase 2 trial for silevertinib in NSCLC, partially offset by increased spend related to the start-up activities for the Phase 2 trial for silevertinib in GBM.
•General and Administrative Expenses: General and administrative (G&A) expenses were $4.7 million for the second quarter of 2026, compared to $4.1 million for the same period in 2025. The increase in G&A expenses was primarily due to an increase in IP-related costs.
•Net Loss: Net loss for the second quarter of 2026 was $9.9 million, as compared to a net loss of $10.6 million for the same period in 2025.
Financial Guidance
•Black Diamond ended the second quarter of 2026 with approximately $110.5 million in cash, cash equivalents, and investments which the Company believes is sufficient to fund its anticipated operating expenses and capital expenditure requirements into the second half of 2028.
About Silevertinib
Silevertinib is an investigational oral, covalent, brain-penetrant fourth-generation tyrosine kinase inhibitor (TKI) that selectively targets classical and more than 50 non-classical EGFR mutations in NSCLC. It is also designed to potently inhibit key EGFR alterations seen in GBM, including EGFRvIII, while avoiding the paradoxical EGFR activation reported with reversible TKIs. To date, over 200 patients with EGFRm NSCLC or EGFR-altered GBM have been treated with silevertinib.
In addition to the ongoing Phase 2 trial of silevertinib in patients with non-classical EGFRm NSCLC, the Company also initiated a randomized Phase 2 trial of silevertinib in patients with newly diagnosed EGFRvIII-positive GBM (NCT07326566) in May 2026.
(Press release, Black Diamond Therapeutics, AUG 5, 2026, View Source [SID1234669719])