ORR and preliminary duration of treatment data for the Phase 2 trial of silevertinib in 1L patients with non-classical EGFRm NSCLC on track for this quarter Cash, cash equivalents, and investments of $135.5 million as of September 30, 2025; expected to be sufficient to fund operations into Q4 of 2027 CAMBRIDGE, Mass., Nov. 06, 2025 (GLOBE NEWSWIRE) -- Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations ...

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 September 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 ...

Black Diamond Therapeutics Reports Third Quarter 2025 Financial Results and Provides Corporate Update CAMBRIDGE, MA, November 6, 2025 (GLOBE NEWSWIRE) – Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with cancer, today reported financial results for the third quarter ended September 30, 2025, and provided a corporate update. "We are looking forward to sharing a clinical update later thi ...

Core Insights - Black Diamond Therapeutics, Inc. (BDTX) and ORIC Pharmaceuticals (ORIC) are both clinical-stage oncology companies focused on developing next-generation cancer therapies [1][2] - The competition between BDTX and ORIC centers on the strength of their respective pipelines [2] BDTX Overview - BDTX is developing MasterKey therapies targeting oncogenic mutations, with its lead candidate being silevertinib, a fourth-generation EGFR MasterKey inhibitor [3][4] - Silevertinib has shown durable clinical responses in a phase I study for patients with recurrent EGFRm non-small cell lung cancer (NSCLC) [4] - BDTX is currently conducting a phase II study for silevertinib in both recurrent and frontline settings, with initial results expected in late 2025 [5][6] - The company has a global licensing agreement with Servier Pharmaceuticals for BDTX-4933, receiving an upfront payment of $70 million, allowing BDTX to focus solely on silevertinib [8] - As of Q2 2025, BDTX had approximately $142.8 million in cash, sufficient to fund operations into Q4 2027 [9] ORIC Overview - ORIC is advancing a pipeline of innovative therapies targeting resistance mechanisms in cancer, focusing on hormone-dependent cancers and precision oncology [12][13] - Key candidates include ORIC-944, an allosteric inhibitor for prostate cancer, and enozertinib, targeting various mutations in NSCLC [13][14] - ORIC has reported promising data for ORIC-944 in combination with AR inhibitors, with plans for further updates in late 2025 and a phase III study initiation in early 2026 [15][16] - ORIC is also conducting a phase I study for enozertinib, with initial data expected in mid-2026 [17][18] - A recent strategic prioritization will focus resources on ORIC-944 and ORIC-114, resulting in a 20% workforce reduction, extending the cash runway into the second half of 2028 [19] Financial Estimates and Performance - BDTX's earnings per share (EPS) estimate for 2025 suggests a 127.56% year-over-year increase, although recent revisions have been downward [20][21] - ORIC's EPS estimates for 2025 and 2026 have remained unchanged over the past 60 days [20][22] - Year-to-date, BDTX shares have increased by 85%, while ORIC shares have risen by 56.1%, compared to a 12.5% gain in the industry [22] - Valuation-wise, BDTX trades at 1.70X trailing 12-month book value, which is lower than ORIC's 3.78X [24] Comparative Analysis - Both companies have made significant progress in their oncology pipelines, but ORIC's broader pipeline and better cash runway position it as a more favorable investment compared to BDTX's reliance on silevertinib [25][26] - Silevertinib has the potential to address a wide range of mutations in NSCLC, but BDTX's limited pipeline poses risks if development setbacks occur [27][28]

Core Insights - Black Diamond Therapeutics, Inc. (BDTX) is focused on developing MasterKey therapies targeting oncogenic mutations in cancer patients, with its lead drug silevertinib being a fourth-generation EGFR MasterKey inhibitor for EGFRm non-small cell lung cancer (NSCLC) and glioblastoma (GBM) [1][10] Development and Pipeline - BDTX is currently conducting a phase II study of silevertinib in patients with EGFRm NSCLC, evaluating it in both recurrent and frontline settings, with FDA feedback anticipated in the first half of 2026 [2][10] - Following a global licensing agreement with Servier Pharmaceuticals for BDTX-4933, BDTX is now solely focused on silevertinib, making its pipeline dependent on the success of this single candidate [3][4][10] Competitive Landscape - The NSCLC market is highly competitive, dominated by major pharmaceutical companies such as AstraZeneca and Johnson & Johnson, with AstraZeneca's Tagrisso being a leading treatment option [5][6] - Johnson & Johnson's Rybrevant has recently gained FDA approval for first-line treatment in specific NSCLC patient populations, presenting additional competition for BDTX's silevertinib [7][8] Financial Performance - BDTX shares have increased by 75.7% year-to-date, significantly outperforming the industry average growth of 9.5% [9] - The company's shares are currently trading at a price/book ratio of 1.61x, which is lower than its historical mean of 1.31x and the biotech industry's average of 3.36x, indicating a potentially undervalued position [11]

Core Insights - The biotechnology sector has seen notable momentum, with four stocks entering the top 10th percentile based on significant week-on-week gains [1][2] Group 1: Key Biotech Stocks - Aldeyra Therapeutics Inc. (ALDX) experienced a momentum percentile surge from 32.07 to 91.32, marking a 59.25-point increase, with an 8.62% year-to-date rise and a 6.58% increase over the year [6] - Alector Inc. (ALEC) improved its momentum percentile from 87.61 to 92.19, a 4.58-point rise, showing a 66.14% year-to-date increase but a decline of 30.99% over the year [6] - Black Diamond Therapeutics Inc. (BDTX) advanced its percentile from 88.36 to 92.61, a 4.25-point gain, with a remarkable 101.87% year-to-date increase and a 25.58% rise over the year [7] - Coherus Oncology Inc. (CHRS) edged up from 89.10 to 92.71, a climb of 3.61 percentile points, with a 30.00% year-to-date increase and an impressive 87.63% rise over the year [7] Group 2: Market Context - The S&P 500 index closed 0.28% lower, while the Nasdaq 100 and Dow Jones indices also saw declines of 0.15% and 0.52% respectively [5] - Futures for the S&P 500, Dow Jones, and Nasdaq 100 indices were trading higher on the following Friday, indicating potential market recovery [5]

Core Insights - The biotechnology sector has seen notable momentum, with four stocks entering the top 10th percentile based on significant week-on-week gains [1][2] Group 1: Key Biotech Stocks - Aldeyra Therapeutics Inc. (ALDX) experienced a momentum percentile surge from 32.07 to 91.32, marking a 59.25-point increase, with an 8.62% year-to-date rise and a 6.58% increase over the year [6] - Alector Inc. (ALEC) improved its momentum percentile from 87.61 to 92.19, a 4.58-point rise, showing a 66.14% year-to-date increase but a decline of 30.99% over the year [6] - Black Diamond Therapeutics Inc. (BDTX) advanced its percentile from 88.36 to 92.61, a 4.25-point gain, with a year-to-date increase of 101.87% and a 25.58% rise over the year [7] - Coherus Oncology Inc. (CHRS) edged up from 89.10 to 92.71, a climb of 3.61 percentile points, with a 30.00% year-to-date increase and an 87.63% rise over the year [7] Group 2: Market Context - The S&P 500 index closed 0.28% lower, while the Nasdaq 100 and Dow Jones indices also saw declines of 0.15% and 0.52% respectively, indicating a mixed market environment [5]

Core Insights - Black Diamond Therapeutics, Inc. (BDTX) has demonstrated exceptional performance in 2025, with shares reaching a 52-week high of $4.1 on October 8, reflecting an 86.4% increase year-to-date, significantly outperforming the industry growth of 10.4% [1][9]. Company Performance - BDTX's stock has outperformed the sector and the S&P 500 Index during the same period [1]. - The company's success is largely attributed to the promising progress of its lead pipeline candidate, silevertinib [1]. Lead Drug Development - Silevertinib is a fourth-generation epidermal growth factor receptor (EGFR) MasterKey inhibitor targeting EGFR mutant non-small cell lung cancer (NSCLC) and glioblastoma (GBM) [5]. - The drug has shown good tolerability and durable clinical responses in a Phase I study involving patients with recurrent EGFRm NSCLC [6]. - BDTX is currently conducting a Phase II study of silevertinib in both recurrent and frontline settings for EGFRm NSCLC [6][7]. Clinical Trials and Data - Enrollment for frontline patients with non-classical EGFR mutations was completed in July 2025, with plans to disclose response rates and duration of response data in Q4 2025 [7]. - The developmental plan includes seeking FDA feedback on a potential registrational path in the first half of 2026 [8]. Financial Position - As of the end of Q2 2025, BDTX had approximately $142.8 million in cash and cash equivalents [12]. - The company entered a global licensing agreement with Servier Pharmaceuticals for its second clinical-stage asset, BDTX-4933, receiving an upfront payment of $70 million [12]. Valuation Metrics - BDTX shares currently trade at a price/book ratio of 1.71x, which is lower than its historical mean of 1.31x and the biotech industry's average of 3.28x [14]. Market Potential - The oncology market, particularly in the NSCLC space, is highly lucrative, with competition from major players like Johnson & Johnson and AstraZeneca [18]. - Silevertinib has the potential to treat both newly diagnosed and recurrent EGFRm NSCLC patients, targeting over 50 oncogenic driver mutations with greater potency than existing EGFR tyrosine kinase inhibitors [18]. Investment Recommendation - The successful development and commercialization of silevertinib could significantly enhance BDTX's value, making it an attractive investment opportunity [19].

Group 1 - Medpace (MEDP) has returned 59.8% year-to-date, significantly outperforming the Medical sector, which has gained about 1.8% on average [4] - Medpace holds a Zacks Rank of 2 (Buy), indicating a positive earnings outlook with a consensus estimate for full-year earnings moving 10.4% higher in the past quarter [3] - The Medical Services industry, to which Medpace belongs, has lost an average of 0.3% so far this year, further highlighting Medpace's strong performance [5] Group 2 - Black Diamond (BDTX) is another Medical stock that has outperformed the sector with a year-to-date return of 86.5% and holds a Zacks Rank of 1 (Strong Buy) [4][5] - The Medical - Biomedical and Genetics industry, which includes Black Diamond, has gained 8.7% year-to-date and is currently ranked 96 [6] - Investors interested in Medical stocks should closely monitor both Medpace and Black Diamond for continued strong performance [6]

A strong stock as of late has been Black Diamond (BDTX) . Shares have been marching higher, with the stock up 28.5% over the past month. The stock hit a new 52-week high of $4.03 in the previous session. Black Diamond has gained 83.2% since the start of the year compared to the 1.5% move for the Zacks Medical sector and the 8.1% return for the Zacks Medical - Biomedical and Genetics industry.What's Driving the Outperformance?The stock has a great record of positive earnings surprises, having beaten the Zack ...