Black Diamond Therapeutics(BDTX) - 2025 Q2 - Quarterly Results

Company Overview and Business Update This section provides an overview of Black Diamond Therapeutics' recent financial results, key clinical developments for silevertinib, and future strategic milestones Introduction and CEO Commentary Black Diamond Therapeutics announced its Q2 2025 financial results, with the CEO highlighting the completion of silevertinib's Phase 2 enrollment for EGFRm NSCLC and ongoing partnership explorations - Phase 2 clinical trial for silevertinib in newly diagnosed EGFRm NSCLC patients has completed enrollment[3] - Clinical update data is anticipated in Q4 2025[3] - Partnership opportunities are being explored to advance silevertinib's pivotal development[3] Recent Developments & Upcoming Milestones (Silevertinib) The company completed enrollment for silevertinib's Phase 2 trial in first-line non-classical EGFRm NSCLC and plans to release ORR and DOR data in Q4 2025, while seeking partnerships for pivotal development - silevertinib (BDTX-1535) Phase 2 clinical trial in first-line non-classical EGFRm NSCLC patients (n=43) has completed enrollment[6][7] - Objective Response Rate (ORR) and preliminary Duration of Response (DOR) data are expected in Q4 2025[6][7] - Partnership opportunities are being explored to advance silevertinib's pivotal development in NSCLC and Glioblastoma (GBM)[6][7] - Plans to meet with the FDA in H1 2026 to discuss the first-line NSCLC development pathway when PFS data becomes available[6][7] Financial Highlights & Guidance As of June 30, 2025, Black Diamond Therapeutics held $142.8 million in cash, cash equivalents, and investments, projected to fund operations through Q4 2027, with significant reductions in Q2 2025 R&D and G&A expenses Cash, Cash Equivalents, and Investments | Metric | June 30, 2025 | December 31, 2024 | | :--- | :------------ | :-------------- | | Amount (Million USD) | $142.8 | $98.6 | - Cash runway is projected to support operations through Q4 2027[6][8] Operating Cash Usage (Q2) | Metric | Q2 2025 | Q2 2024 | Change | | :--- | :------------- | :------------- | :--- | | Net Cash Used (Million USD) | $9.2 | $14.7 | -$5.5 | Research and Development Expenses (Q2) | Metric | Q2 2025 | Q2 2024 | Change | | :--- | :------------- | :------------- | :--- | | Amount (Million USD) | $9.3 | $12.6 | -$3.3 | General and Administrative Expenses (Q2) | Metric | Q2 2025 | Q2 2024 | Change | | :--- | :------------- | :------------- | :--- | | Amount (Million USD) | $4.1 | $9.6 | -$5.5 | Net Loss (Q2) | Metric | Q2 2025 | Q2 2024 | Change | | :--- | :------------- | :------------- | :--- | | Amount (Million USD) | $10.6 | $19.9 | -$9.3 | About Black Diamond Therapeutics Black Diamond Therapeutics is a clinical-stage oncology company developing MasterKey therapies for oncogenic mutation families, with a focus on advancing silevertinib in Phase 2 NSCLC trials - Black Diamond Therapeutics is a clinical-stage oncology company developing MasterKey therapies for families of oncogenic mutations[9] - MasterKey therapies aim to address broad genetically defined tumors, overcome resistance, minimize wild-type mediated toxicity, and possess brain penetrance[9] - The company is advancing a Phase 2 NSCLC trial for silevertinib, a brain-penetrant fourth-generation EGFR MasterKey inhibitor[9] Financial Results This section details Black Diamond Therapeutics' condensed consolidated balance sheet data and statements of operations, highlighting significant changes in cash, assets, and net income/loss Condensed Consolidated Balance Sheet Data As of June 30, 2025, the company's cash, cash equivalents, and investments increased to $142.8 million, total assets rose to $166.4 million, and total stockholders' equity significantly grew to $132.6 million Condensed Consolidated Balance Sheet Data (Unaudited, in Thousands USD) | Metric | June 30, 2025 | December 31, 2024 | | :---------------------------- | :------------ | :---------------- | | Cash, Cash Equivalents, and Investments (Thousands USD) | $142,829 | $98,575 | | Total Assets (Thousands USD) | $166,385 | $122,640 | | Accumulated Deficit (Thousands USD) | $(441,126) | $(487,107) | | Total Stockholders' Equity (Thousands USD) | $132,610 | $83,285 | Consolidated Statements of Operations In Q2 2025, the company reported a net loss of $10.6 million, a significant reduction from $19.9 million in Q2 2024, and achieved a net income of $46.0 million for the six months ended June 30, 2025, driven by $70.0 million in license revenue Consolidated Statements of Operations (Unaudited, in Thousands USD, except per share data) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | License Revenue (Thousands USD) | $— | $— | $70,000 | $— | | Research and Development Expenses (Thousands USD) | $9,319 | $12,556 | $19,825 | $26,101 | | General and Administrative Expenses (Thousands USD) | $4,101 | $9,574 | $9,065 | $16,275 | | Total Operating Expenses (Thousands USD) | $13,420 | $22,130 | $28,890 | $42,376 | | Operating (Loss) Income (Thousands USD) | $(13,420) | $(22,130) | $41,110 | $(42,376) | | Net (Loss) Income (Thousands USD) | $(10,561) | $(19,909) | $45,981 | $(38,134) | | Net (Loss) Income Per Share - Basic (USD) | $(0.19) | $(0.36) | $0.81 | $(0.71) | | Net (Loss) Income Per Share - Diluted (USD) | $(0.19) | $(0.36) | $0.80 | $(0.71) | - For the six months ended June 30, 2025, the company recorded $70.0 million in license revenue, contributing to net income[16] Legal and Contact Information This section includes forward-looking statements regarding clinical development and financial projections, along with essential contact information for investor relations and media inquiries Forward-Looking Statements This section contains forward-looking statements regarding silevertinib's development, clinical timelines, regulatory feedback, potential collaborations, and cash runway, emphasizing that actual results may differ due to risks - Statements regarding silevertinib's development, clinical trial timelines, regulatory feedback, potential collaborations, and the company's cash runway are forward-looking[12] - Actual results may differ materially from forward-looking statements due to risks and uncertainties outlined in SEC filings[12] - The company undertakes no obligation to update such statements to reflect events or circumstances occurring after their publication[12] Contact Information Provides contact details for investor relations and media inquiries - Investor contact: investors@bdtx.com[17] - Media contact: media@bdtx.com[17]