Page 1

BLACK DIAMOND THERAPEUTICS Black Diamond Therapeutics Reports Second Quarter 2026 Financial Results and Provides Corporate Update • • • Presented positive Phase 2 results for silevertinib in frontline patients with non - classical EGFRm NSCLC at the 2026 ASCO Annual Meeting , including that no patients developed de novo brain metastases and that patients with baseline brain metastases achieved a CNS objective response rate of 86 % The results position silevertinib as a potential best - in - class brain - penetrant EGFR inhibitor ; an update on the Phase 2 trial and FDA feedback on a pivotal development path for silevertinib in frontline patients with non- classical EGFRM NSCLC are anticipated in Q4 2026 Cash , cash equivalents , and investments of $ 110.5 million as of June 30 , 2026 , expected to be sufficient to fund operations into 2H of 2028 CAMBRIDGE , MA , August 5 , 2026 ( GLOBE NEWSWIRE ) - 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 , today reported financial results for the second quarter ended June 30 , 202 , and provided a corporate update . " Silevertinib continued to demonstrate robust clinical activity and durable responses in frontline patients with non - classical EGFR - mutant NSCLC , as presented at ASCO in May , " said Mark Velleca , M.D. , Ph.D. , President and Chief ecutive Officer of Black Diamond Therapeutics . " We are particularly encouraged that no patients developed de novo brain metastases and that the CNS ORR was 8 % in patients with baseline brain metastases . Appro imately 80 % of all patients with non - classical EGFR mutations progress in the brain , and appro imately 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 . " E Recent Developments & Upcoming Milestones : • On May 30 , 202 , at the American Society of Clinical Oncology ( ASCO ) Annual Meeting , data were QD ) in 43 frontline NSCLC presented from the Phase 2 trial of silevertinib dosed at 200 mg once daily ( patients harboring a broad spectrum of EGFR non - classical mutations , including compound and P - Loop and C- Heli Compressing ( PACC ) mutations . As of an April 11 , 202 data cutoff date , results were as follows ° Objective Response Rate ( Disease Control Rate ( ° ORR by RECIST 1.1 ) , CNS ORR ( DCR ) were 0 % , 8 % and 91 % , respectively ORR by RANO - BM ) , and Variant allele frequency reduction observed in all evaluable patients across 25 unique EGFR non - classical mutations , including PACC 0 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 . ני Safety , pharmacokinetics , pharmacodynamics and efficacy data support a 150 mg QD dose for pivotal development