Core Viewpoint - Black Diamond (BDTX) has been upgraded to a Zacks Rank 1 (Strong Buy) due to an upward trend in earnings estimates, which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Price Movement - The Zacks rating system is based on a company's changing earnings picture, specifically tracking the Zacks Consensus Estimate for EPS from sell-side analysts [1][2]. - Changes in future earnings potential, as indicated by earnings estimate revisions, are strongly correlated with near-term stock price movements [4][6]. - For Black Diamond, rising earnings estimates and the rating upgrade indicate an improvement in the company's underlying business, which is expected to positively influence its stock price [5][10]. Zacks Rank System - The Zacks Rank stock-rating system classifies stocks into five groups based on four factors related to earnings estimates, with Zacks Rank 1 stocks historically generating an average annual return of +25% since 1988 [7][9]. - Only the top 5% of Zacks-covered stocks receive a "Strong Buy" rating, indicating superior earnings estimate revisions and potential for market-beating returns [9][10]. Recent Performance of Black Diamond - For the fiscal year ending December 2025, Black Diamond is expected to earn $0.33 per share, unchanged from the previous year, but the Zacks Consensus Estimate has increased by 37.3% over the past three months [8].

Company Performance - Black Diamond (BDTX) has returned 29% year-to-date, significantly outperforming the average return of -3% for Medical companies [4] - The Zacks Consensus Estimate for BDTX's full-year earnings has increased by 37.3% over the past quarter, indicating improved analyst sentiment and a stronger earnings outlook [3] - Biorestorative Therapies, Inc. (BRTX) has also shown strong performance, with a year-to-date increase of 6.3% and a consensus EPS estimate increase of 12.5% over the past three months [4][5] Industry Context - Black Diamond is part of the Medical - Biomedical and Genetics industry, which includes 487 stocks and currently ranks 146 in the Zacks Industry Rank [6] - The Medical - Biomedical and Genetics industry has gained an average of 4.1% so far this year, indicating that BDTX is performing better than its industry peers [6] - The Medical sector, which includes 976 individual stocks, holds a Zacks Sector Rank of 7, suggesting a relatively weaker performance compared to other sectors [2]

[PART I - FINANCIAL INFORMATION](index=6&type=section&id=PART%20I%20-%20FINANCIAL%20INFORMATION) Presents unaudited financial statements and management's discussion of financial condition and operations [Item 1. Condensed Consolidated Financial Statements (Unaudited)](index=6&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(Unaudited)) Presents unaudited financial statements, showing **increased** net income and cash from license revenue [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Details the company's financial position, including assets, liabilities, and stockholders' equity | Metric | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :-------------------------------- | :----------------------------- | :------------------------------- | | Cash and cash equivalents | $29,993 | $36,437 | | Investments | $112,836 | $62,138 | | Total current assets | $146,726 | $101,176 | | Total assets | $166,385 | $122,640 | | Total current liabilities | $16,805 | $20,573 | | Total liabilities | $33,775 | $39,355 | | Total stockholders' equity | $132,610 | $83,285 | | Accumulated deficit | $(441,126) | $(487,107) | - **Total assets increased** by **$43.7 million**, from **$122.6 million** at December 31, 2024, to **$166.4 million** at June 30, 2025, **primarily due to a significant increase** in investments[18](index=18&type=chunk) - **Total stockholders' equity increased** by **$49.3 million**, from **$83.3 million** at December 31, 2024, to **$132.6 million** at June 30, 2025, **driven by** net income and additional paid-in capital[18](index=18&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Income%20(Loss)) Reports financial performance, showing net income from license revenue and reduced operating expenses | Metric (in thousands) | 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 | $0 | $0 | $70,000 | $0 | | R&D expenses | $9,319 | $12,556 | $19,825 | $26,101 | | G&A expenses | $4,101 | $9,574 | $9,065 | $16,275 | | Total operating expenses| $13,420 | $22,130 | $28,890 | $42,376 | | Income (loss) from operations | $(13,420) | $(22,130) | $41,110 | $(42,376) | | Net income (loss) | $(10,561) | $(19,909) | $45,981 | $(38,134) | | Net income (loss) per share - basic | $(0.19) | $(0.36) | $0.81 | $(0.71) | - For the six months ended June 30, 2025, the Company reported a net income of **$46.0 million**, a **significant improvement** from a net loss of **$38.1 million** in the prior year, **primarily due to $70.0 million** in license revenue[19](index=19&type=chunk) - Operating expenses **decreased** for both the three and six months ended June 30, 2025, **driven by** reductions in R&D and G&A expenses due to workforce efficiencies and the outlicensing of BDTX-4933[19](index=19&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Summarizes cash inflows and outflows from operating, investing, and financing activities | Metric (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :---------------------- | :----------------------------- | :----------------------------- | | Net cash provided by (used in) operating activities | $44,251 | $(35,925) | | Net cash provided by (used in) investing activities | $(50,606) | $(12,994) | | Net cash provided by (used in) financing activities | $(84) | $25,508 | | Net (decrease) increase in cash and cash equivalents | $(6,439) | $(23,411) | | Cash, cash equivalents and restricted cash, end of period | $30,817 | $33,633 | - Operating activities **generated $44.3 million** in cash for the six months ended June 30, 2025, a **substantial improvement** from a **$35.9 million** cash usage in the prior year, **primarily due to** the upfront license payment[21](index=21&type=chunk)[123](index=123&type=chunk) - Cash used in investing activities **increased** to **$50.6 million** for the six months ended June 30, 2025, mainly due to purchases of investments exceeding sales and maturities[21](index=21&type=chunk)[125](index=125&type=chunk) [Condensed Consolidated Statements of Stockholders' Equity](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) Details changes in stockholders' equity, including common stock, paid-in capital, and accumulated deficit | Metric (in thousands, except shares) | December 31, 2024 | June 30, 2025 | | :----------------------------------- | :---------------- | :------------ | | Common stock shares | 56,644,655 | 56,886,939 |\ | Additional paid-in capital | $570,361 | $573,754 |\ | Accumulated deficit | $(487,107) | $(441,126) |\ | Total stockholders' equity | $83,285 | $132,610 | - **Total stockholders' equity increased** by **$49.3 million** from December 31, 2024, to June 30, 2025, **primarily due to** net income and stock-based compensation, partially offset by shares surrendered for taxes[24](index=24&type=chunk) [Notes to Unaudited Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Provides detailed explanations and disclosures supporting the condensed consolidated financial statements - Black Diamond Therapeutics is a clinical-stage oncology company focused on MasterKey therapies for oncogenic mutations in cancer, utilizing its Mutation-Allostery-Pharmacology (MAP) drug discovery engine[26](index=26&type=chunk) - The Company entered into a global licensing agreement with Servier Pharmaceuticals LLC for BDTX-4933 in March 2025, receiving an upfront payment of **$70.0 million** and eligible for up to **$710.0 million** in development and commercial sales milestones, plus tiered royalties[28](index=28&type=chunk)[75](index=75&type=chunk) - As of August 7, 2025, the Company expects its cash, cash equivalents, and investments to fund planned operations for at least the next 12 months from the filing date[30](index=30&type=chunk) - Revenue recognition for the Servier Agreement's **$70.0 million** upfront payment was recognized upon transfer of control of the license at a point in time upon contract execution in March 2025[77](index=77&type=chunk)[80](index=80&type=chunk) - The Company operates as a single reporting segment, focused on developing MasterKey therapies for oncogenic mutations in cancer[72](index=72&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=25&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Discusses financial condition, operations, and liquidity, highlighting the Servier agreement and funding [Overview](index=26&type=section&id=Overview) Introduces the company's oncology focus, lead product silevertinib, and the Servier licensing agreement - Black Diamond Therapeutics is a clinical-stage oncology company developing MasterKey therapies targeting oncogenic mutations in cancer, with a focus on brain-penetrant compounds[83](index=83&type=chunk) - Silevertinib (formerly BDTX-1535) is the lead clinical-stage program, a fourth-generation EGFR MasterKey inhibitor for EGFRm NSCLC and glioblastoma (GBM), with Phase 2 clinical trials ongoing[83](index=83&type=chunk)[84](index=84&type=chunk) - Enrollment for frontline EGFRm NSCLC patients (cohort 3) in the Phase 2 trial was completed in July 2025, with initial results expected in Q4 2025. The Company plans to seek FDA feedback on a potential registrational path in H1 2026[85](index=85&type=chunk) - In March 2025, the Company entered a global licensing agreement with Servier for BDTX-4933, receiving an upfront payment of **$70.0 million**. Servier will lead development and commercialization of BDTX-4933 for RAF/RAS-mutant solid tumors[83](index=83&type=chunk)[88](index=88&type=chunk) - The Company reported net income of **$46.0 million** for the six months ended June 30, 2025, compared to a net loss of **$38.1 million** for the same period in 2024, **primarily due to** the Servier upfront payment[90](index=90&type=chunk) [Components of our results of operations](index=29&type=section&id=Components%20of%20our%20results%20of%20operations) Explains the key revenue and expense categories impacting the company's financial results - The Company has not **generated** product revenue since inception and expects future revenue from product sales or collaboration/license agreements[96](index=96&type=chunk) - Research and development expenses are expensed as incurred, including costs for preclinical studies, clinical trials, CROs, CMOs, and employee-related expenses[97](index=97&type=chunk)[99](index=99&type=chunk) - General and administrative expenses include salaries, benefits, stock-based compensation for executive, business development, finance, HR, legal, IT, pre-commercial, and support personnel, as well as facility costs and professional fees[103](index=103&type=chunk) - Other income (expense) **primarily consists** of interest income from cash and investments, sublease income, and foreign currency transaction gains/losses[106](index=106&type=chunk) [Results of operations](index=31&type=section&id=Results%20of%20operations) Compares financial performance for the three and six months, detailing revenue and expense changes Three Months Ended June 30, 2025 vs. 2024 | Metric (in thousands) | 2025 | 2024 | Change | | :-------------------- | :---------- | :---------- | :---------- | | R&D expenses | $9,319 | $12,556 | $(3,237) | | G&A expenses | $4,101 | $9,574 | $(5,473) | | Net loss | $(10,561) | $(19,909) | $9,348 | - Research and development expenses **decreased** by **$3.2 million** for the three months ended June 30, 2025, **primarily due to** workforce efficiencies and a **$1.6 million decrease** in BDTX-4933 spend following its outlicensing[108](index=108&type=chunk)[109](index=109&type=chunk) - General and administrative expenses **decreased** by **$5.5 million** for the three months ended June 30, 2025, mainly due to operational and workforce efficiencies from a corporate restructuring[110](index=110&type=chunk) Six Months Ended June 30, 2025 vs. 2024 | Metric (in thousands) | 2025 | 2024 | Change | | :-------------------- | :---------- | :---------- | :---------- | | License revenue | $70,000 | $0 | $70,000 | | R&D expenses | $19,825 | $26,101 | $(6,276) | | G&A expenses | $9,065 | $16,275 | $(7,210) | | Net income (loss) | $45,981 | $(38,134) | $84,115 | - License revenue of **$70.0 million** was recorded for the six months ended June 30, 2025, resulting from the upfront payment from the Servier Agreement[113](index=113&type=chunk) - Research and development expenses **decreased** by **$6.3 million** for the six months ended June 30, 2025, **driven by** operational efficiencies for silevertinib and a **$2.1 million decrease** in BDTX-4933 spend due to its licensing[114](index=114&type=chunk) [Liquidity and capital resources](index=34&type=section&id=Liquidity%20and%20capital%20resources) Discusses funding sources, cash position, and future capital requirements for operations - The Company has funded operations **primarily through** common and preferred stock sales, and the **$70.0 million** upfront payment from the Servier Agreement[117](index=117&type=chunk)[120](index=120&type=chunk) - As of June 30, 2025, cash, cash equivalents, and investments totaled **$142.8 million**[121](index=121&type=chunk) - The Company believes its existing cash, cash equivalents, and investments will fund operating expenses and capital expenditure requirements into the fourth quarter of 2027[94](index=94&type=chunk)[129](index=129&type=chunk) - Future funding requirements are expected to **increase substantially** with the advancement of silevertinib's clinical trials and potential commercialization activities[128](index=128&type=chunk)[130](index=130&type=chunk) Contractual Obligations as of June 30, 2025 (in thousands) | Type of Obligation | Less than 1 Year | 1 to 3 Years | 3 to 5 Years | More than 5 Years | Total | | :----------------- | :--------------- | :----------- | :----------- | :---------------- | :---- | | Property leases | $4,538 | $9,448 | $4,819 | $5,026 | $23,831 | [Critical accounting policies and significant judgments and use of estimates](index=39&type=section&id=Critical%20accounting%20policies%20and%20significant%20judgments%20and%20use%20of%20estimates) Outlines key accounting policies and the **significant** estimates and judgments involved - The Company's critical accounting policies, including revenue recognition under ASC 606, involve **significant** estimates and judgments that affect reported financial amounts[137](index=137&type=chunk)[138](index=138&type=chunk) [Recently issued accounting pronouncements](index=39&type=section&id=Recently%20issued%20accounting%20pronouncements) Addresses the impact of new accounting standards on the company's financial statements - The Company will evaluate the impact of ASU 2024-03 (Expense Disaggregation Disclosures) effective for fiscal years beginning after December 15, 2026, and ASU 2023-09 (Improvements to Income Tax Disclosures) effective for annual periods beginning after December 15, 2024, on its financial statements[43](index=43&type=chunk)[44](index=44&type=chunk) [Emerging growth company and smaller reporting company status](index=40&type=section&id=Emerging%20growth%20company%20and%20smaller%20reporting%20company%20status) Clarifies the company's regulatory classifications and associated disclosure obligations - The Company is an "emerging growth company" and has elected not to opt out of the extended transition period for new accounting standards[140](index=140&type=chunk) - The Company also qualifies as a "smaller reporting company," allowing for reduced disclosure obligations[141](index=141&type=chunk) - Effective December 31, 2025, the Company will no longer qualify as an "emerging growth company"[142](index=142&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=40&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) States that as a smaller reporting company, market risk disclosures are not required - The Company is a smaller reporting company and is not required to provide quantitative and qualitative disclosures about market risk[143](index=143&type=chunk) [Item 4. Controls and Procedures](index=40&type=section&id=Item%204.%20Controls%20and%20Procedures) Confirms the effectiveness of disclosure controls and procedures, with no material changes in internal control - Disclosure controls and procedures were evaluated and deemed effective as of June 30, 2025[144](index=144&type=chunk) - No material changes in internal control over financial reporting occurred during the period covered by this Quarterly Report[145](index=145&type=chunk) [PART II - OTHER INFORMATION](index=39&type=section&id=PART%20II%20-%20OTHER%20INFORMATION) Presents other required information, including legal proceedings, risk factors, and equity security disclosures [Item 1. Legal Proceedings](index=39&type=section&id=Item%201.%20Legal%20Proceedings) Confirms no material legal proceedings or claims are currently impacting the company's business - The Company is not currently party to any material legal proceedings and is not aware of any claims that would have a material adverse effect on its business[147](index=147&type=chunk) [Item 1A. Risk Factors](index=41&type=section&id=Item%201A.%20Risk%20Factors) Updates risks related to government funding, geopolitical disruptions, collaborations, and healthcare legislation - Inadequate funding or disruptions at the FDA and other government agencies could delay product development and approvals, negatively impacting the business[149](index=149&type=chunk)[151](index=151&type=chunk) - Broad business, economic, or geopolitical disruptions, including high inflation, rising interest rates, and international tariffs, could harm development efforts and **increase** costs[152](index=152&type=chunk)[154](index=154&type=chunk) - Collaborations, such as the Servier Agreement for BDTX-4933, carry risks including partners not meeting obligations, insufficient effort, or disputes, which could adversely affect the Company's business[157](index=157&type=chunk)[159](index=159&type=chunk) - Healthcare legislative measures, including the Inflation Reduction Act of 2022 (IRA) and the One Big Beautiful Bill Act of 2025 (OBBBA), could impact drug pricing, Medicare negotiation, and orphan drug exemptions, potentially affecting revenue prospects and profitability[171](index=171&type=chunk) - Changes in U.S. federal tax law, such as those introduced by the OBBBA regarding R&D expense capitalization and amortization, could adversely affect the Company's business and financial condition[182](index=182&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=47&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) Reports no unregistered sales or issuer purchases of equity securities during the period - No unregistered sales of equity securities occurred[183](index=183&type=chunk) - No issuer purchases of equity securities occurred[184](index=184&type=chunk) [Item 3. Defaults Upon Senior Securities](index=50&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) Confirms no defaults occurred on senior securities during the reporting period - There were no defaults upon senior securities[185](index=185&type=chunk) [Item 4. Mine Safety Disclosures](index=50&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) States that mine safety disclosures are not applicable to the company's operations - Mine safety disclosures are not applicable[186](index=186&type=chunk) [Item 5. Other Information](index=50&type=section&id=Item%205.%20Other%20Information) Reports no Rule 10b5-1 or non-Rule 10b5-1 trading arrangements by directors or officers - No Rule 10b5-1 or non-Rule 10b5-1 trading arrangements were adopted or terminated by directors or officers during the three months ended June 30, 2025[187](index=187&type=chunk) [Item 6. Exhibits](index=51&type=section&id=Item%206.%20Exhibits) Lists certifications, XBRL documents, and other exhibits filed with the Quarterly Report - Exhibits include certifications from the Principal Executive Officer and Principal Financial Officer, as well as Inline XBRL documents for financial data[189](index=189&type=chunk)

[Company Overview and Business Update](index=1&type=section&id=Company%20Overview%20and%20Business%20Update) 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](index=1&type=section&id=Introduction%20and%20CEO%20Commentary) 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](index=3&type=chunk) - Clinical update data is anticipated in Q4 2025[3](index=3&type=chunk) - Partnership opportunities are being explored to advance silevertinib's pivotal development[3](index=3&type=chunk) [Recent Developments & Upcoming Milestones (Silevertinib)](index=1&type=section&id=Recent%20Developments%20%26%20Upcoming%20Milestones%20(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](index=6&type=chunk)[7](index=7&type=chunk) - Objective Response Rate (ORR) and preliminary Duration of Response (DOR) data are expected in **Q4 2025**[6](index=6&type=chunk)[7](index=7&type=chunk) - Partnership opportunities are being explored to advance silevertinib's pivotal development in NSCLC and Glioblastoma (GBM)[6](index=6&type=chunk)[7](index=7&type=chunk) - Plans to meet with the FDA in **H1 2026** to discuss the first-line NSCLC development pathway when PFS data becomes available[6](index=6&type=chunk)[7](index=7&type=chunk) [Financial Highlights & Guidance](index=1&type=section&id=Financial%20Highlights%20%26%20Guidance) 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](index=6&type=chunk)[8](index=8&type=chunk) 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](index=2&type=section&id=About%20Black%20Diamond%20Therapeutics) 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](index=9&type=chunk) - MasterKey therapies aim to address broad genetically defined tumors, overcome resistance, minimize wild-type mediated toxicity, and possess brain penetrance[9](index=9&type=chunk) - The company is advancing a Phase 2 NSCLC trial for **silevertinib**, a brain-penetrant fourth-generation EGFR MasterKey inhibitor[9](index=9&type=chunk) [Financial Results](index=4&type=section&id=Financial%20Results) 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](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheet%20Data) 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](index=4&type=section&id=Consolidated%20Statements%20of%20Operations) 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](index=16&type=chunk) [Legal and Contact Information](index=3&type=section&id=Legal%20and%20Contact%20Information) 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](index=3&type=section&id=Forward-Looking%20Statements) 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](index=12&type=chunk) - Actual results may differ materially from forward-looking statements due to risks and uncertainties outlined in SEC filings[12](index=12&type=chunk) - The company undertakes no obligation to update such statements to reflect events or circumstances occurring after their publication[12](index=12&type=chunk) [Contact Information](index=5&type=section&id=Contact%20Information) Provides contact details for investor relations and media inquiries - Investor contact: **investors@bdtx.com**[17](index=17&type=chunk) - Media contact: **media@bdtx.com**[17](index=17&type=chunk)

BDTX-1535 Clinical Development - BDTX-1535 is a MasterKey therapy targeting families of oncogenic mutations, designed to expand the addressable patient population [4,5,8] - BDTX-1535 is in Phase 2 clinical trials for 2L/3L NSCLC with final data expected in H1 2026, and 1L NSCLC with initial data expected in Q4 2025 [9] - BDTX-1535 is also in Phase 0/1 clinical trials for GBM with initial data in newly diagnosed patients expected in H1 2026 [9] - Preliminary Phase 2 data shows a 42% ORR in recurrent NSCLC patients with PACC-NCM and/or C797S mutations [58] - The company anticipates FDA feedback on the approval pathway for BDTX-1535 in Q4 2025 [84] EGFR Mutations and Treatment Landscape - 23-30% of newly diagnosed EGFRm NSCLC patients carry non-classical mutations (NCMs) [14,17,28] - Real-world data shows that approximately 60% of 1L patients with EGFR-NCM NSCLC receive chemotherapy [21,22,28] - Median time on treatment for 1L NCM NSCLC is less than 8 months [23,28] - BDTX-1535 demonstrates high potency across the spectrum of NCMs and maintains activity where osimertinib loses potency [26,28,32,34] Financial Status - The company ended Q1 2025 with $152.4 million, providing a cash runway into Q4 2027 [5]

Core Insights - The article argues that the decline of Black Diamond Therapeutics (NASDAQ: BDTX) is not justified by the facts, especially considering upcoming trial readouts in the biotech sector [1] Company Analysis - Black Diamond Therapeutics is highlighted as a company with potential, particularly in the context of its clinical trials and the biochemistry expertise of the analyst [1] Industry Context - The article emphasizes the importance of understanding the science behind biotech investments, suggesting that informed analysis can help investors avoid pitfalls in this sector [1]

Summary of Black Diamond Therapeutics (BDTX) 2025 Conference Company Overview - **Company**: Black Diamond Therapeutics (BDTX) - **Industry**: Biotechnology, specifically focused on precision small molecule oncology - **Lead Program**: Fourth generation EGFR TKI in phase two development for non-small cell lung cancer (NSCLC) patients with non-classical mutations [3][4] Key Points and Arguments Market Opportunity - Approximately **25%** of newly diagnosed NSCLC patients have non-classical EGFR mutations [4] - About **33%** of these patients present with CNS metastases at diagnosis, highlighting the need for brain-penetrant therapies [6] Current Treatment Landscape - No established standard of care for newly diagnosed patients with non-classical EGFR mutations - **60%** of patients receive chemotherapy with poor outcomes; **20%** receive Afatinib, and another **20%** receive off-label Osimertinib [7] - Osimertinib shows a response rate of **20-40%** and a treatment duration of about **6 months**; Afatinib has a similar duration of **8 months** but lacks CNS penetrance [8] Product Positioning - BDTX's fourth generation EGFR TKI (1535) is designed to target the full spectrum of non-classical mutations and is CNS penetrant, positioning it uniquely in the market [9] - The company is the most advanced in this category, with a significant opportunity in the frontline setting [9] Clinical Development and Data Readout - Enrollment for the trial is ongoing, with approximately **30 patients** expected to have at least **6 months** of follow-up by the fourth quarter [10] - Efficacy measures will include Overall Response Rate (ORR) and Duration of Response (DOR) [10] - The company plans to disclose regulatory feedback alongside clinical data to provide a comprehensive update [12] Safety Profile - The safety profile of the drug is favorable, with low rates of known EGFR TKI adverse events (AEs) [20] - The company is proactive in educating physicians about managing potential AEs, particularly rash, which is common in frontline patients [21] Regulatory Strategy - The company is considering a phase three randomized trial for accelerated approval, likely comparing against Afatinib [23][24] - There is potential for interim readouts based on response rates and durability of response [24] Competitive Landscape - Competitors include Fermomertinib, which has limited activity on non-classical mutations, and other agents like AMI and ORIC Pharmaceuticals, which focus on different mutation subsets [41][44] - BDTX believes that having a full spectrum of activity is crucial for success in this market [43] Financial Position - As of the first quarter, the company has **$152.4 million** in cash, with a conservative estimate of runway until the end of **2027** [53][54] - The partnership with Servier could yield up to **$710 million** in milestones, which is not included in the current cash guidance [54] Future Outlook - The company is focused on presenting frontline data later this year, which is a key point of interest for investors [55] Additional Important Information - The company has deprioritized development in the recurrent setting to focus on the larger frontline market [38] - The ongoing phase two study in glioblastoma (GBM) is expected to provide additional safety data and insights into the drug's efficacy in CNS tumors [49][50]

Company Overview - Black Diamond Therapeutics, Inc. is a clinical-stage oncology company focused on developing MasterKey therapies that target families of oncogenic mutations in cancer patients [3] - The company's MasterKey therapies aim to address a wide range of genetically defined tumors, overcome resistance, minimize wild-type mediated toxicities, and penetrate the brain to treat central nervous system diseases [3] Upcoming Events - The CEO, Mark Velleca, M.D., Ph.D., will participate in a fireside chat at the Jefferies Global Healthcare Conference on June 4, 2025, in New York, NY [1] - The company will also host one-on-one meetings with investors on the same day [1] Product Development - Black Diamond Therapeutics is advancing a Phase 2 trial for BDTX-1535, which is a brain-penetrant fourth-generation epidermal growth factor receptor (EGFR) MasterKey inhibitor targeting EGFR-mutant non-small cell lung cancer (NSCLC) and glioblastoma [3]

PART I [Condensed Consolidated Financial Statements (Unaudited)](index=7&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20%28Unaudited%29) This section presents the unaudited condensed consolidated financial statements for Q1 2025, showing a net income of **$56.5 million** primarily from **$70.0 million** in Servier license revenue [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets increased to **$176.2 million** by March 31, 2025, primarily due to higher cash, with stockholders' equity rising to **$141.5 million** Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $98,424 | $36,437 | | Total current assets | $155,679 | $101,176 | | **Total assets** | **$176,245** | **$122,640** | | **Liabilities & Equity** | | | | Total current liabilities | $16,847 | $20,573 | | Total liabilities | $34,729 | $39,355 | | **Total stockholders' equity** | **$141,516** | **$83,285** | [Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Income%20%28Loss%29) The company reported a net income of **$56.5 million** for Q1 2025, a significant turnaround from a net loss in Q1 2024, driven by **$70.0 million** in license revenue Statement of Operations Summary (in thousands, except per share data) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | License revenue | $70,000 | $— | | Research and development | $10,506 | $13,545 | | General and administrative | $4,964 | $6,701 | | **Income (loss) from operations** | **$54,530** | **($20,246)** | | **Net income (loss)** | **$56,542** | **($18,225)** | | Net income (loss) per share - basic | $1.00 | ($0.35) | [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash provided by operating activities was **$53.4 million** in Q1 2025, a significant reversal from the prior year, ending the quarter with **$99.2 million** in cash and equivalents Cash Flow Summary (in thousands) | Activity | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net cash provided by (used in) operating activities | $53,410 | ($21,199) | | Net cash provided by (used in) investing activities | $8,547 | ($13,734) | | Net cash provided by financing activities | $32 | $4,130 | | **Net (decrease) increase in cash** | **$61,989** | **($30,803)** | [Condensed Consolidated Statements of Stockholders' Equity](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders%27%20Equity) Total stockholders' equity increased to **$141.5 million** by March 31, 2025, primarily due to the **$56.5 million** net income recorded during the quarter - Total stockholders' equity increased to **$141.5 million** as of March 31, 2025, up from **$83.3 million** at the end of 2024, mainly due to the **$56.5 million** net income for the quarter[23](index=23&type=chunk) [Notes to Unaudited Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the Servier licensing agreement's **$70.0 million** upfront payment and confirm sufficient cash for the next 12 months - In March 2025, the company entered into a global licensing agreement with Servier Pharmaceuticals LLC for BDTX-4933[27](index=27&type=chunk)[76](index=76&type=chunk) - The Servier agreement provided a **$70.0 million** upfront payment and eligibility for up to **$710.0 million** in development and commercial sales milestone payments, plus tiered royalties[27](index=27&type=chunk)[76](index=76&type=chunk) - The company expects its cash, cash equivalents, and investments will be sufficient to fund planned operations for at least the next 12 months from the filing date[29](index=29&type=chunk) - The **$70.0 million** upfront payment was recognized as license revenue in Q1 2025, as it was determined to be a single performance obligation (license of functional IP) satisfied at contract execution[78](index=78&type=chunk)[81](index=81&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=26&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the **$70.0 million** Servier licensing agreement and the company's **$152.4 million** cash position, expected to fund operations into Q4 2027 [Overview](index=26&type=section&id=MD%26A%20Overview) The overview highlights the **$70.0 million** Servier licensing agreement and **$152.4 million** in cash, funding operations into Q4 2027 - The lead clinical program, BDTX-1535, is being evaluated in a Phase 2 trial for first-line EGFRm NSCLC, with initial results anticipated in Q4 2025[85](index=85&type=chunk) - A global licensing agreement was signed with Servier in March 2025 for BDTX-4933, providing a **$70.0 million** upfront payment[84](index=84&type=chunk)[88](index=88&type=chunk) - The company believes its cash, cash equivalents, and investments of **$152.4 million** as of March 31, 2025, will fund operations into the fourth quarter of 2027[94](index=94&type=chunk) [Results of Operations](index=31&type=section&id=MD%26A%20Results%20of%20Operations) Q1 2025 saw **$70.0 million** in license revenue, leading to **$54.5 million** in operating income, with reduced R&D and G&A expenses due to efficiencies Comparison of Operations (in thousands) | Metric | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | License revenue | $70,000 | $— | $70,000 | | Research and development | $10,506 | $13,545 | ($3,039) | | General and administrative | $4,964 | $6,701 | ($1,737) | | **Income (loss) from operations** | **$54,530** | **($20,246)** | **$74,776** | - R&D expenses decreased by **$3.0 million** YoY, primarily due to operational efficiencies for BDTX-1535 and decreased spending on BDTX-4933 following its licensing[110](index=110&type=chunk)[111](index=111&type=chunk) - G&A expenses decreased by **$1.7 million** YoY, mainly from operational and workforce efficiencies resulting from the October 2024 corporate restructuring[112](index=112&type=chunk) [Liquidity and Capital Resources](index=32&type=section&id=MD%26A%20Liquidity%20and%20Capital%20Resources) Liquidity was significantly bolstered by the **$70.0 million** Servier upfront payment, resulting in **$152.4 million** in cash and investments, funding operations into Q4 2027 - As of March 31, 2025, the company had cash, cash equivalents, and investments of **$152.4 million**[119](index=119&type=chunk)[126](index=126&type=chunk) - The company received a **$70.0 million** upfront payment from Servier in March 2025 under a licensing agreement for BDTX-4933[118](index=118&type=chunk) Cash Flow Summary (in thousands) | Activity | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Cash provided by (used in) operating activities | $53,410 | ($21,199) | | Cash provided by (used in) investing activities | $8,547 | ($13,734) | | Cash provided by financing activities | $32 | $4,130 | [Quantitative and Qualitative Disclosures about Market Risk](index=37&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) As a smaller reporting company, the company is not required to provide market risk disclosures - As a smaller reporting company, the company is not required to provide quantitative and qualitative disclosures about market risk[143](index=143&type=chunk) [Controls and Procedures](index=37&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2025, with no material changes to internal control over financial reporting - Management concluded that disclosure controls and procedures were effective as of March 31, 2025[144](index=144&type=chunk) - No material changes in internal control over financial reporting were identified during the quarter ended March 31, 2025[145](index=145&type=chunk) PART II - OTHER INFORMATION [Legal Proceedings](index=38&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings that would adversely affect its business - The company is not currently aware of any material legal proceedings that would have a material adverse effect on its business, financial condition, or results of operations[147](index=147&type=chunk) [Risk Factors](index=38&type=section&id=Item%201A.%20Risk%20Factors) Key risks include potential delays from inadequate government agency funding, macroeconomic and geopolitical disruptions, and dependence on partner performance under the Servier license agreement - Inadequate funding, personnel turnover, or shutdowns at the FDA and other government agencies could hinder the ability to review and approve new products in a timely manner[149](index=149&type=chunk)[150](index=150&type=chunk) - Macroeconomic conditions, political unrest, high inflation, and international trade disruptions (e.g., tariffs) could adversely affect research and development activities and increase costs[151](index=151&type=chunk) - The company's success with BDTX-4933 is now dependent on Servier's performance under the license agreement, and future collaborations carry similar risks of non-performance or strategic shifts by partners[157](index=157&type=chunk)[159](index=159&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=41&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reports no unregistered sales of equity securities during the period - There were no unregistered sales of equity securities in the reported period[161](index=161&type=chunk) [Defaults Upon Senior Securities](index=42&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reports no defaults upon senior securities - None[163](index=163&type=chunk) [Mine Safety Disclosures](index=42&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[164](index=164&type=chunk) [Other Information](index=42&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted or terminated Rule 10b5-1 trading arrangements during the quarter - During the three months ended March 31, 2025, none of the company's directors or officers adopted or terminated a Rule 10b5-1 trading arrangement[165](index=165&type=chunk) [Exhibits](index=43&type=section&id=Item%206.%20Exhibits) This section lists filed exhibits, including the Servier License Agreement and certifications from the Principal Executive and Financial Officers - Filed exhibits include the License Agreement with Servier Pharmaceuticals LLC, dated March 18, 2025[167](index=167&type=chunk) - Certifications by the Principal Executive Officer and Principal Financial Officer pursuant to Sarbanes-Oxley Act sections 302 and 906 are included as exhibits[167](index=167&type=chunk) [Signatures](index=44&type=section&id=SIGNATURES)

[Q1 2025 Financial Results and Corporate Update](index=1&type=section&id=Black%20Diamond%20Therapeutics%20Reports%20First%20Quarter%202025%20Financial%20Results%20and%20Provides%20Corporate%20Update) Black Diamond Therapeutics reported Q1 2025 results, highlighting BDTX-1535 trial progress and a Servier deal extending cash runway [Report Overview](index=1&type=section&id=Report%20Overview) Black Diamond Therapeutics reported Q1 2025 results, highlighting BDTX-1535 trial progress and a Servier deal extending cash runway - The company is executing on enrollment for the BDTX-1535 Phase 2 trial for newly diagnosed EGFRm NSCLC patients, with a clinical update expected in **Q4 2025**[3](index=3&type=chunk) - A global licensing agreement with Servier for BDTX-4933 has provided a strong cash position, with an expected runway into **Q4 2027**[3](index=3&type=chunk) - Pending FDA feedback in **Q4 2025**, the company is positioned to begin pivotal development of BDTX-1535 in the **first half of 2026**[3](index=3&type=chunk) [Recent Developments & Upcoming Milestones](index=1&type=section&id=Recent%20Developments%20%26%20Upcoming%20Milestones) The company detailed progress for BDTX-1535 in NSCLC and GBM trials, alongside a significant Servier licensing deal for BDTX-4933 [BDTX-1535 Program Updates](index=1&type=section&id=BDTX-1535) Black Diamond is on track to disclose initial Phase 2 data for BDTX-1535 in EGFRm NSCLC in Q4 2025, and expanded its GBM trial - Initial Phase 2 clinical data for BDTX-1535 in newly diagnosed non-classical EGFRm NSCLC patients is expected in **Q4 2025**[5](index=5&type=chunk)[6](index=6&type=chunk) - An investigator-sponsored Phase 0/1 trial was expanded in **March 2025** to include newly diagnosed glioblastoma (GBM) patients with EGFR alterations[5](index=5&type=chunk)[6](index=6&type=chunk) - Data presented at the AACR Annual Meeting for BDTX-1535 in recurrent GBM patients showed encouraging pharmacokinetic and safety data, providing a strong rationale for program expansion[6](index=6&type=chunk) [Corporate Developments](index=2&type=section&id=Corporate) Black Diamond finalized a global licensing agreement with Servier for BDTX-4933, securing **$70 million** upfront and potential milestone payments Servier Licensing Agreement Terms | Term | Value | | :--- | :--- | | Upfront Payment | $70.0 million (received March 2025) | | Potential Milestone Payments | Up to $710.0 million | | Royalties | Tiered royalties on global net sales | - Servier will lead the development activities and worldwide commercialization of BDTX-4933 for multiple indications, including NSCLC[7](index=7&type=chunk) [Financial Highlights](index=2&type=section&id=Financial%20Highlights) The company reported strong Q1 2025 financials, with **$56.5 million** net income and cash runway into Q4 2027, driven by a licensing deal [Financial Guidance and Cash Position](index=2&type=section&id=Financial%20Guidance%20and%20Cash%20Position) As of March 31, 2025, Black Diamond's cash, cash equivalents, and investments stood at **$152.4 million**, sufficient to fund operations into Q4 2027 Cash Position | Date | Cash, Cash Equivalents, and Investments (in millions) | | :--- | :--- | | March 31, 2025 | $152.4 | | December 31, 2024 | $98.6 | - The company believes its current cash position is sufficient to fund anticipated operating expenses and capital expenditure requirements into the **fourth quarter of 2027**[9](index=9&type=chunk) Net Cash from Operations (YoY, in millions) | Period | Net Cash Provided By/(Used In) Operations | | :--- | :--- | | Q1 2025 | $53.4 | | Q1 2024 | ($21.2) | [Q1 2025 Operating Results](index=2&type=section&id=Q1%202025%20Operating%20Results) Black Diamond reported **$56.5 million** net income for Q1 2025, a significant improvement driven by license revenue and reduced operating expenses Q1 Operating Results Comparison (in millions) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net Income / (Loss) | $56.5 | ($18.2) | | R&D Expenses | $10.5 | $13.5 | | G&A Expenses | $5.0 | $6.7 | - The decrease in R&D expenses was primarily due to workforce efficiencies and increased focus on BDTX-1535 development[12](index=12&type=chunk) - The decrease in G&A expenses was primarily due to the restructuring announced in **October 2024**[12](index=12&type=chunk) [Condensed Consolidated Financial Statements](index=4&type=section&id=Condensed%20Consolidated%20Financial%20Statements) Q1 2025 unaudited financials show total assets of **$176.2 million** and equity of **$141.5 million**, driven by **$70 million** license revenue Condensed Consolidated Balance Sheet Data (Unaudited, in millions) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash, cash equivalents, and investments | $152.4 | $98.6 | | Total assets | $176.2 | $122.6 | | Total stockholders' equity | $141.5 | $83.3 | Consolidated Statements of Operations (Unaudited, in millions) | Account | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | License revenue | $70.0 | $0 | | Total operating expenses | $15.5 | $20.2 | | Net income (loss) | $56.5 | ($18.2) | | Net income (loss) per share - basic | $1.00 | ($0.35) |