Core Insights - Black Diamond Therapeutics' lead program, silevertinib, is a fourth-generation EGFR MasterKey inhibitor targeting EGFR mutant non-small cell lung cancer and glioblastoma [1][2] Development and Clinical Trials - Silevertinib can potentially treat newly diagnosed and recurrent EGFRm NSCLC patients, targeting over 50 oncogenic driver mutations with higher potency than existing EGFR TKIs [2] - The drug is currently in mid-stage studies for EGFRm NSCLC, with enrollment in frontline patients completed in July 2025, and initial results expected in Q4 2025 [3][10] - The company anticipates FDA feedback on a potential registrational path for silevertinib in frontline EGFRm NSCLC in the first half of 2026 [4] Competitive Landscape - AstraZeneca's Tagrisso is a dominant third-generation EGFR-TKI, approved in over 120 countries, and is being evaluated in early-stage settings [5] - Johnson & Johnson's Rybrevant, approved in August 2024, is the first multitargeted, chemotherapy-free regimen showing superiority over Tagrisso for first-line treatment of EGFR-mutated NSCLC [6][7] Financial Performance - BDTX shares have increased by 52.3% year-to-date, outperforming the industry growth of 4.7% [9] - The current price/book ratio for BDTX is 1.40x, which is higher than its historical mean of 1.31x but lower than the biotech industry's average of 3.20x [12] - The bottom-line estimate for 2025 has improved to a profit of 33 cents, while the 2026 estimate reflects a loss of 82 cents per share [13]

Core Insights - Black Diamond Therapeutics, Inc. (BDTX) and Cullinan Therapeutics, Inc. (CGEM) are both clinical-stage biotech companies focused on developing therapies for cancer, particularly targeting specific oncogenic mutations [2][3] BDTX Overview - BDTX is advancing its lead candidate, silevertinib, a fourth-generation EGFR MasterKey inhibitor aimed at treating EGFR mutant non-small cell lung cancer (NSCLC) and glioblastoma (GBM) [4][24] - Silevertinib has shown durable clinical responses in a phase I study involving patients with recurrent EGFRm NSCLC, including those with various mutation subtypes [5][8] - The company is currently conducting a phase II study for silevertinib in both recurrent and frontline settings, with initial results expected in late 2025 [6][8] - BDTX has entered a global licensing agreement with Servier Pharmaceuticals for its second asset, BDTX-4933, receiving an upfront payment of $70 million, allowing it to focus solely on silevertinib [9][23] CGEM Overview - CGEM is co-developing zipalertinib, an irreversible EGFR inhibitor targeting EGFR exon 20 insertion mutations, with Taiho Pharmaceutical [10][12] - Zipalertinib has met its phase IIb endpoint in patients with EGFR ex20ins NSCLC, with plans for a new drug application submission by the end of 2025 [11][12] - CGEM has a broader pipeline, including candidates for NSCLC and multiple myeloma, but has seen a decline in EPS estimates over the past 60 days [13][17] Comparative Performance - BDTX shares have increased by 59.8% year-to-date, while CGEM shares have decreased by 48.4%, contrasting with a 5.2% gain in the industry [19] - BDTX is trading at a lower valuation of 5.87X forward sales compared to CGEM's 15.56X [21] - The Zacks Consensus Estimate for BDTX's 2025 EPS suggests a significant increase of 125.98%, while CGEM's estimates have moved downward [15][17] Investment Outlook - BDTX is currently rated as a Zacks Rank 2 (Buy), while CGEM holds a Zacks Rank 4 (Sell) [23] - BDTX's silevertinib is positioned as a promising candidate in the competitive NSCLC market, targeting a wide range of mutations, including the C797S resistance mutation [24][25]

Core Viewpoint - Black Diamond Therapeutics, Inc. (NASDAQ:BDTX) is identified as a stock with significant upside potential, with Guggenheim initiating coverage with a "Buy" rating and a price target of $8.00, indicating a potential increase of 146.5% from the current price [1] Group 1: Company Overview - Black Diamond Therapeutics, Inc. is a clinical-stage oncology company founded in 2014, based in Cambridge, Massachusetts, focusing on discovering and developing MasterKey therapies for genetically defined tumors [3] - The company has outperformed the market by nearly 40% year-to-date, suggesting a favorable investment opportunity as the stock may experience substantial rallies [3] Group 2: Product Pipeline and Expectations - Analysts have high expectations for the company's silevertinib Phase 2 data, which is anticipated in the second half of 2025 [1] - Silevertinib's preclinical profile is designed for broad-spectrum mutation selectivity over wild-type EGFR, aiming to achieve a 50% objective response rate (ORR) and a 10-month median progression-free survival (mPFS) [2] - The strong second-line response rates after osimertinib treatment may attract strategic partnerships in the future [2]

Core Insights - Black Diamond Therapeutics, Inc. (BDTX) is focused on developing MasterKey therapies targeting oncogenic mutations in cancer patients, with its lead candidate being silevertinib, a fourth-generation EGFR MasterKey inhibitor for NSCLC and glioblastoma [1][10] Financial Overview - As of the end of Q2 2025, Black Diamond had approximately $142.8 million in cash and cash equivalents, which is expected to fund operations into Q4 2027 [2][10] - Operating expenses in Q2 2025 decreased by 39%, primarily due to reduced R&D and G&A expenses, with R&D costs declining due to workforce efficiencies and the outlicensing of BDTX-4933 [3][4] Strategic Developments - BDTX entered a global licensing agreement with Servier Pharmaceuticals for BDTX-4933, receiving an upfront payment of $70 million, allowing the company to concentrate solely on silevertinib [4][10] - The company is actively seeking strategic partners to further develop silevertinib for NSCLC and glioblastoma [5] Competitive Landscape - The NSCLC market is competitive, with Johnson & Johnson's Rybrevant and Lazcluze combination recently receiving FDA approval, positioning it as a significant competitor against BDTX's silevertinib [6][8] - AstraZeneca's Tagrisso is another competitor in the space, particularly for patients with EGFR non-classical mutations [8][9] Market Performance - BDTX shares have increased by 57.5% year-to-date, outperforming the industry growth of 5.6% [13] - The current price/book ratio for BDTX is 1.45x, which is higher than its historical mean of 1.31x but lower than the biotech industry's average of 3.16x [14] Earnings Estimates - The bottom-line estimate for 2025 has improved to a profit of 33 cents per share, while the estimate for 2026 has been adjusted to a loss of 82 cents per share [15][17] - Recent estimate revisions indicate a significant upward trend, with a 512.50% increase for the 2026 estimate [17]

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].

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)