Key Takeaways Black Diamond is advancing silevertinib for EGFR-mutant NSCLC and glioblastoma.BDTX outlicensed BDTX-4933 to Servier for $70M, streamlining focus on silevertinib.Cash reserves of $142.8M are expected to fund operations into Q4 2027.Black Diamond Therapeutics, Inc. ((BDTX) is developing MasterKey therapies that target families of oncogenic mutations in patients with cancer. The company’s lead pipeline candidate is silevertinib.Silevertinib is a brain penetrant, fourth-generation epidermal growt ...

Core Insights - Black Diamond Therapeutics, Inc. (BDTX) has demonstrated a strong performance in 2023, with shares increasing by 51.1% over the past six months, significantly outperforming the industry decline of 1.6% [1][9] - The company's success is largely attributed to the promising progress of its pipeline, particularly the lead candidate, silevertinib, which targets oncogenic mutations in cancer patients [2][4] Pipeline Progress - Silevertinib is a fourth-generation EGFR MasterKey inhibitor aimed at treating EGFR mutant non-small cell lung cancer (NSCLC) and glioblastoma [4] - In a phase I study, silevertinib showed good tolerability and durable clinical responses in patients with recurrent EGFRm NSCLC, including those with various mutation subtypes [5] - Currently, BDTX is conducting a phase II study of silevertinib in both recurrent and frontline settings for EGFRm NSCLC, with enrollment for frontline patients completed in July 2025 [6] - Initial data from September 2024 indicated encouraging clinical responses in 27 patients with EGFRm NSCLC in second and third-line settings [7] Market Position and Focus - Following the outlicensing of BDTX-4933 to Servier Pharmaceuticals, BDTX is now solely focused on the development of silevertinib [9][14] - The company ended Q2 2025 with approximately $142.8 million in cash and cash equivalents, following a $70 million upfront payment from the licensing agreement [13] Valuation and Estimates - BDTX shares are currently trading at a price/book ratio of 1.23x, which is lower than its historical mean of 1.31x and the biotech industry's average of 3.13x, indicating an inexpensive valuation [15] - Recent estimates for 2025 and 2026 have shown positive revisions, with significant increases in bottom-line estimates [16] Investment Potential - The oncology market is highly lucrative, and while competition exists, silevertinib has shown potential to treat both newly diagnosed and recurrent EGFRm NSCLC patients [19][20] - The successful development and commercialization of silevertinib could significantly enhance BDTX's market position and shareholder value [21]

Company Overview - Black Diamond Therapeutics, Inc. (BDTX) is focused on the development of its lead pipeline candidate, silevertinib, which is a fourth-generation EGFR MasterKey inhibitor targeting EGFR mutant non-small cell lung cancer (NSCLC) and glioblastoma (GBM) [1][3] - The company has completed enrollment in a mid-stage study of silevertinib in frontline NSCLC patients with non-classical EGFR mutations [1][9] Development Plans - BDTX plans to disclose objective response rate and preliminary duration of response data from 43 patients in the study in the fourth quarter of 2025 [2][9] - The developmental plan includes seeking FDA feedback on a potential registrational path for silevertinib in frontline EGFRm NSCLC in the first half of 2026, contingent on progression-free survival data from the ongoing phase II study [2] Strategic Focus - Following the outlicensing of BDTX-4933 to Servier Pharmaceuticals, the company is solely focused on silevertinib [3] - BDTX is actively seeking strategic partners to advance the development of silevertinib for NSCLC and GBM [3] Competitive Landscape - The NSCLC market is highly competitive, with major pharmaceutical and biotech companies developing similar therapies [4] - Johnson & Johnson (JNJ) received FDA approval for Rybrevant plus Lazcluze for first-line treatment of NSCLC, which has demonstrated superiority over AstraZeneca's Tagrisso [5][6] - Silevertinib will compete with Tagrisso, which is a third-generation EGFR-TKI with proven clinical activity in NSCLC [7] Financial Performance - BDTX shares have decreased by 34.6% year-to-date, contrasting with the industry's growth of 5.7% [8] - The company's shares currently trade at a price/book ratio of 1.24x, lower than its historical mean of 1.28x and the biotech industry's average of 3.13x [11] Earnings Estimates - The bottom-line estimate for 2025 remains stable at a profit of 33 cents, while the estimate for 2026 is unchanged at a loss of 82 cents [12]

Company Overview - Black Diamond Therapeutics (BDTX) is a clinical stage biotechnology firm focused on developing treatments for EGFR-mutated non-small cell lung cancer (NSCLC) [1] Product Development - The main candidate of BDTX is BDTX-1535, also known as Silvertinib, which is currently being investigated in both first line and advanced lines of treatment for NSCLC [1]

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].

For those looking to find strong Medical stocks, it is prudent to search for companies in the group that are outperforming their peers. Black Diamond (BDTX) is a stock that can certainly grab the attention of many investors, but do its recent returns compare favorably to the sector as a whole? Let's take a closer look at the stock's year-to-date performance to find out. Black Diamond is a member of the Medical sector. This group includes 976 individual stocks and currently holds a Zacks Sector Rank of #7. T ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 ___________________________________________ FORM 10-Q _______________________________________________________________________________ ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM _ TO _ COMMISSION FILE NUMBE ...

[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]