New Risk • Jun 16
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: US$98.6m This is considered a minor risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 18% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$102m net loss in 3 years). Share price has been volatile over the past 3 months (15% average weekly change). Market cap is less than US$100m (US$98.6m market cap). Announcement • May 24
Black Diamond Therapeutics Announces Positive Phase 2 Results for Silevertinib in Frontline NSCLC Patients With EGFR Non-Classical Mutations Black Diamond Therapeutics, Inc. announced positive results from its Phase 2 trial of silevertinib in frontline (1L) non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) non-classical mutations (NCMs). These data will be presented by Julia Rotow, M.D., Clinical Director, Lowe Center for Thoracic Oncology at the Dana-Farber Cancer Institute, at the 2026 American Society of Clinical Oncology Annual Meeting on Saturday, May 30, 2026, 1:15 PM-2:45 PM CDT. Silevertinib 1L NSCLC Phase 2 Results Summary Results as of an April 11, 2026 data cutoff date include: 43 patients with 1L NSCLC were enrolled at a 200 mg once daily dose of silevertinib. Patients presented with a broad spectrum of EGFR-NCMs, including compound and P-Loop and C-Helix Compressing (PACC) mutations. 19 patients with brain metastases, 7 of whom had measurable central nervous system (CNS) target lesions. 11.2 months median follow-up. Durability: Preliminary median Progression-free Survival (mPFS) is 15.2 months (95% CI: 10.8; NE). Median duration of response (DOR) had not been reached (95%CI: 7.0, NE). 23 of 43 patients (53%) remain on therapy, with longest at 23.5 months. CNS Activity: No patients developed de novo brain metastases. Previously disclosed CNS Objective Response Rate (ORR by RANO-BM) remained at 86%. ORR and DCR: Previously disclosed Objective Response Rate (ORR by RECIST 1.1) and Disease Control Rate (DCR) remained at 60% and 91%, respectively. Variant allele frequency (VAF) reduction observed in all evaluable patients across 25 unique EGFR-NCMs, including PACC. Safety: No new safety signals were observed. The rate of TRAEs > Grade 3 was reduced to 28% following dose reduction. Patients maintained or deepened clinical responses after dose reduction. Safety and efficacy data support 150 mg QD for pivotal development. 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 EGFR-mutant NSCLC or EGFR-altered GBM have been treated with silevertinib. In addition to the ongoing Phase 2 trial of silevertinib in patients with 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. New Risk • May 19
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 11% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 17% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$96m net loss in 3 years). Share price has been volatile over the past 3 months (11% average weekly change).