{"url_path":"/sec/bdtx/8-k/2026-05-21/item-8-01","section_key":"item-8-01","section_title":"Item 8.01 Other Events.**","topic":"sec","document":{"doc_type":"8-K","doc_date":"2026-05-21","source_url":"https://www.sec.gov/Archives/edgar/data/1701541/0001104659-26-065254-index.html","accession_number":"0001104659-26-065254","cik":"0001701541","ticker":"BDTX","issuer_name":"Black Diamond Therapeutics, Inc.","edgar_url":"https://www.sec.gov/Archives/edgar/data/1701541/0001104659-26-065254-index.html","primary_entity_key":"0001701541","primary_entity_name":"Black Diamond Therapeutics, Inc."},"word_count":597,"has_tables":true,"body_markdown":"**Item 8.01. Other Events.**\n\n \n\nOn May 21, 2026, the Company announced results\nfrom its Phase 2 trial of silevertinib in frontline (“1L”) non-small cell lung cancer (“NSCLC”) patients with\nepidermal growth factor receptor (“EGFR”) non-classical mutations (“NCMs”).\n\n \n\n**Silevertinib 1L NSCLC Phase 2 Results Summary**\n\n \n\nForty-three frontline NSCLC patients harboring\na broad spectrum of EGFR-NCMs, including compound and P-Loop and C-Helix Compressing (“PACC”) mutations, were enrolled, including\n19 patients with brain metastases, seven of whom had measurable central nervous system (“CNS”) target lesions. All patients\nwere enrolled at a 200 mg oral daily dose (“QD”) of silevertinib. Efficacy and safety were assessed with an April 11,\n2026 data cutoff date; median follow-up time as of this date was 11.2 months, and the study remains ongoing.\n\n \n\nKey data highlights include:\n\n \n\n·Durability\n\n \n\noPreliminary median progression-free survival is 15.2 months (95% CI: 10.8, NE)\n\n \n\noMedian duration of response (“DOR”) had not been reached (95% CI: 7.0, NE)\n\n \n\no23 of 43 patients (53%) remain on therapy, with longest at 23.5 months\n\n \n\n·CNS Activity\n\n \n\noNo patients developed *de novo*brain metastases\n\n \n\noPreviously disclosed CNS Objective Response Rate (“ORR”) (ORR by RANO-BM) remained at 86%\n\n \n\n·ORR and DCR\n\n \n\noPreviously disclosed ORR (ORR by RECIST 1.1) and Disease Control Rate (“DCR”) remained at 60% and 91%, respectively\n\n \n\noVariant allele frequency reduction observed in all evaluable patients across 25 unique EGFR-NCMs, including PACC\n\n \n\n·Safety\n\n \n\noNo new safety signals were observed\n\n \n\noThe rate of treatment-related adverse events > Grade 3 was reduced to 28% following dose reduction\n\n \n\noPatients maintained or deepened clinical responses after dose reduction\n\n \n\noSafety and efficacy data support 150 mg QD for pivotal development\n\n \n\n \n\n \n\n \n\n**Forward-Looking Statements**\n\n \n\nStatements contained in this Current Report on\nForm 8-K regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private\nSecurities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially\nfrom those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding:\nthe continued development and advancement of silevertinib, including the ongoing Phase 2 clinical trials and the timing of clinical updates\nfor silevertinib in patients with NSCLC and in patients with GBM, the potential of silevertinib to address the unmet medical need for\nnewly diagnosed GBM patients and newly diagnosed NSCLC patients with non-classical EGFR mutations and benefit patients with NSCLC across\nmultiple lines of therapy, the potential future development plans for silevertinib in NSCLC and GBM, and the competitive landscape and\nmarket for silevertinib or any of the Company’s other current or future product candidates, including statements relating to the\nestimated percentage of newly diagnosed NSCLC patients with non-classical EGFR mutations and the potential addressable patient population.\nAny forward-looking statements in this Current Report on Form 8-K are based on management’s current expectations of future\nevents and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from\nthose set forth in or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking\nstatements include those risks and uncertainties set forth in the Company’s Annual Report on Form 10-K for the year ended December 31,\n2025, filed with the United States Securities and Exchange Commission (the “SEC”) and in its subsequent filings filed with\nthe SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. The Company\nundertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they\nwere made."}