Group 1 - Black Diamond Therapeutics, Inc. announced a strategic worldwide licensing agreement for BDTX-4933 with Servier [1] - Following the announcement, the stock initially surged by 65% but later declined to $1.72 [1] Group 2 - The article reflects the author's personal investment position in BDTX, indicating a beneficial long position [2]

Core Viewpoint - Servier and Black Diamond Therapeutics have entered into a strategic worldwide licensing agreement for BDTX-4933, a targeted therapy for solid tumors, with Servier leading its development and commercialization [1][2][6]. Group 1: Agreement Details - Servier will develop and commercialize BDTX-4933, focusing on multiple indications including non-small cell lung cancer (NSCLC) and other solid tumors [2][6]. - Black Diamond Therapeutics will receive an upfront payment of $70 million and could earn up to $710 million in development and commercial sales milestone payments, along with tiered royalties based on global net sales [2][6]. Group 2: Product Development - BDTX-4933 is currently in Phase 1 development, specifically designed to target RAS and RAF alterations in solid tumors [3][6]. - The ongoing first-in-human study aims to evaluate the safety, tolerability, and preliminary antitumor activity of BDTX-4933 in adults with recurrent advanced/metastatic cancers harboring specific mutations [3][6]. Group 3: Company Profiles - Servier is a global pharmaceutical group governed by a non-profit foundation, focusing on long-term innovation and reinvesting 100% of its profits into development [4][5]. - Black Diamond Therapeutics specializes in developing MasterKey therapies targeting oncogenic mutations, with a focus on addressing genetically defined tumors and overcoming treatment resistance [8].

Core Insights - Servier and Black Diamond Therapeutics have entered into a strategic worldwide licensing agreement for BDTX-4933, a targeted therapy for solid tumors, with Servier responsible for its development and commercialization [1][2][6] - The agreement includes an upfront payment of $70 million to Black Diamond, with potential additional payments of up to $710 million based on development and commercial milestones, along with tiered royalties on global net sales [2][6] Company Overview - Servier is a global pharmaceutical group governed by a non-profit foundation, focusing on significant unmet medical needs and investing approximately 70% of its R&D budget in oncology [5][6] - Black Diamond Therapeutics specializes in developing MasterKey therapies targeting oncogenic mutations, with a focus on precision medicine to address a broad spectrum of genetically defined tumors [8] Product Development - BDTX-4933 is currently in Phase 1 development, specifically designed to target RAS and RAF alterations in solid tumors, including non-small cell lung cancer (NSCLC) [3][6] - The ongoing clinical trial aims to evaluate the safety, tolerability, and preliminary antitumor activity of BDTX-4933 in adults with recurrent advanced/metastatic cancers harboring specific mutations [3][6]

Core Insights - Black Diamond Therapeutics, Inc. is a biotech company focused on developing a next-generation EGFR inhibitor aimed at managing various solid tumors that are dependent on EGFR signaling [1] Company Overview - The company is engaged in the biotechnology sector, specifically targeting the advancement of treatments for solid tumors [1] Expertise and Mission - The article emphasizes the importance of understanding the science behind biotech investments, highlighting the author's background in biochemistry and experience in analyzing clinical trials [1]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 ___________________________________________ FORM 10-K ___________________________________________ ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE FISCAL YEAR ENDED December 31, 2024 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 NUMBER 001-38501 ____________________________ ...

Black Diamond Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Corporate Update • Initial Phase 2 clinical data in newly diagnosed patients with non-classical epidermal growth factor receptor mutant (EGFRm) non-small cell lung cancer (NSCLC) in the second quarter of 2025 (NCT05256290). • Updated Phase 2 clinical data in patients with recurrent EGFRm NSCLC with a broad spectrum of classical, non-classical, and C797S resistance mutations in the second half of 2025. • Plann ...

Core Viewpoint - Black Diamond Therapeutics, Inc. reported its financial results for Q4 and the full year of 2024, highlighting advancements in its clinical programs, particularly BDTX-1535 for treating patients with EGFRm NSCLC and glioblastoma [1][2]. Financial Highlights - Cash, cash equivalents, and investments totaled approximately $98.6 million as of December 31, 2024, down from $131.4 million in 2023, which is expected to fund operations into Q4 2026 [5][7]. - Net loss for Q4 2024 was $16.0 million, an improvement from $19.4 million in Q4 2023. The total net loss for the year was $69.7 million, compared to $82.4 million in 2023 [6][13]. - Research and development expenses decreased to $12.3 million in Q4 2024 from $15.3 million in Q4 2023, and for the full year, R&D expenses were $51.3 million, down from $59.4 million in 2023 [6][13]. Clinical Developments - The company is advancing BDTX-1535 in a Phase 2 trial for newly diagnosed patients with non-classical EGFRm NSCLC, with initial data expected in Q2 2025 [5][6]. - An expansion of the investigator-sponsored "window of opportunity" trial into newly diagnosed glioblastoma patients with EGFR aberrations is anticipated in Q1 2025 [5][6]. - The company plans to seek FDA feedback on a potential pivotal registrational path for BDTX-1535 in the second half of 2025 [6]. Upcoming Milestones - Initial Phase 2 clinical data for BDTX-1535 in non-classical EGFRm NSCLC patients is expected in Q2 2025 [5][6]. - Updated Phase 2 clinical data for recurrent EGFRm NSCLC patients is anticipated in the second half of 2025 [6]. - The trial for glioblastoma patients is set to transition from a Phase 0/1 to a Phase 0/2 trial in Q1 2025 [6]. Company Overview - Black Diamond Therapeutics is focused on developing MasterKey therapies targeting oncogenic mutations in cancer patients, with a specific emphasis on addressing unmet medical needs in NSCLC and glioblastoma [1][8].

Core Viewpoint - Black Diamond (BDTX) has been upgraded to a Zacks Rank 2 (Buy), indicating a positive outlook on its earnings estimates, which significantly influence stock prices [1][3]. Earnings Estimates and Stock Price Impact - The Zacks rating system is based on changes in earnings estimates, which are strongly correlated with near-term stock price movements [4][6]. - Institutional investors often adjust their valuations based on earnings estimates, leading to significant stock price movements when they buy or sell large amounts of shares [4]. Recent Performance and Projections - Black Diamond is projected to earn -$1.30 per share for the fiscal year ending December 2024, reflecting a year-over-year change of 30.9% [8]. - Over the past three months, the Zacks Consensus Estimate for Black Diamond has increased by 7%, indicating a positive trend in earnings estimates [8]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with Zacks Rank 1 (Strong Buy) stocks historically generating an average annual return of +25% since 1988 [7]. - The upgrade to Zacks Rank 2 places Black Diamond in the top 20% of Zacks-covered stocks, suggesting a strong potential for market-beating returns in the near term [10][11].

Core Insights - Black Diamond Therapeutics announced encouraging initial Phase 2 data for BDTX-1535 in patients with recurrent EGFRm NSCLC, showing a preliminary overall response rate (ORR) of 42% in a specific patient group [1][3] - The company presented real-world treatment practices and outcomes for newly diagnosed NSCLC patients with non-classical EGFR mutations at the 2024 ESMO Congress, highlighting heterogeneity in treatment approaches [1][3] - Financial results for Q3 2024 showed a cash position of approximately $112.7 million, expected to fund operations into Q2 2026 [1][5][6] Clinical Developments - Initial Phase 2 data for BDTX-1535 indicated robust EGFRm target coverage and a favorable tolerability profile, with no new safety signals observed [3] - The 200 mg daily dose of BDTX-1535 was selected for pivotal development, with encouraging durability noted in the duration of response (DOR) of approximately eight months or more for some patients [3] - Upcoming clinical updates and regulatory feedback are anticipated in Q1 2025, including a meeting with the FDA regarding a registrational path for BDTX-1535 [2][3] Financial Highlights - As of September 30, 2024, Black Diamond reported cash, cash equivalents, and investments of $112.7 million, down from $131.4 million at the end of 2023 [5][10] - Research and development expenses decreased to $12.9 million in Q3 2024 from $16.2 million in Q3 2023, attributed to workforce efficiencies [5][11] - The net loss for Q3 2024 was $15.6 million, a reduction from $23.0 million in the same period of 2023 [5][11] Corporate Strategy - A corporate restructuring plan was announced to prioritize resources for BDTX-1535 and improve operational efficiencies, extending the expected cash runway into Q2 2026 [4] - The company has deprioritized its Phase 1 RAS/RAF inhibitor, BDTX-4933, and is seeking partnerships for this program [4]

Financial Performance - The company reported net losses of $53.7 million and $63.0 million for the nine months ended September 30, 2024 and 2023, respectively, with an accumulated deficit of $471.1 million as of September 30, 2024[87]. - The company has incurred significant operating losses since inception in 2014, primarily funding operations through the sale of common and preferred stock[86]. - Total operating expenses for the three months ended September 30, 2024, were $18.1 million, a decrease of $5.9 million compared to $24.0 million for the same period in 2023[108]. - For the nine months ended September 30, 2024, total operating expenses were $60.5 million, a decrease of $5.1 million from $65.6 million in 2023[112]. - Cash used in operating activities for the nine months ended September 30, 2024, was $47.2 million, compared to $52.8 million in 2023, reflecting a reduction in net loss[121]. - Cash used in operating activities decreased from $52.8 million in September 2023 to $47.2 million in September 2024[126]. - Cash provided by financing activities decreased significantly from $71.98 million in September 2023 to $25.26 million in September 2024[126]. Research and Development - BDTX-1535 demonstrated a preliminary overall response rate (ORR) of 42% in a Phase 2 trial involving 19 patients with osimertinib-resistant EGFR mutations, with a duration of response (DOR) of approximately eight months or more in the first three patients achieving a partial response[83]. - BDTX-4933, the second product candidate, is currently deprioritized as the company focuses resources on advancing BDTX-1535 into pivotal development[85]. - Initial results from the first-line cohort of BDTX-1535 are anticipated in the first quarter of 2025[83]. - Research and development expenses for the three months ended September 30, 2024, were $12.9 million, down from $16.2 million in 2023, primarily due to reduced spending on early discovery projects[109]. - Research and development expenses for the nine months ended September 30, 2024, were $39.0 million, down from $44.1 million in 2023, reflecting a focus on clinical-stage assets[113]. - The company expects substantial increases in expenses related to advancing clinical trials for BDTX-1535 and operating as a public company[127]. Cash and Investments - As of September 30, 2024, the company had cash, cash equivalents, and investments of approximately $112.7 million, expected to fund operations into the second quarter of 2026[92]. - As of September 30, 2024, the company had cash, cash equivalents, and investments totaling $112.7 million[117]. - The company completed a Follow-on Offering on July 5, 2023, raising approximately $71.6 million in net proceeds[120]. - The total contractual obligations as of September 30, 2024, amounted to $27.2 million, including property leases[133]. - The company expects to require additional capital for regulatory approvals and potential acquisitions of product candidates[128]. - Future funding requirements may increase significantly due to various factors, including clinical trial costs and commercialization activities[129]. - The company may finance operations through public or private equity offerings, debt financings, and strategic partnerships[130]. Business Operations - The company has not generated any revenue from product sales to date and does not expect to do so in the foreseeable future[93]. - The company is actively seeking partnerships for BDTX-4933 while prioritizing the development of BDTX-1535[85]. - The company is monitoring macroeconomic conditions and market volatility, which have not significantly impacted its business or financial results to date[91]. - The company has not experienced material changes in internal control over financial reporting during the reporting period[143]. - The company remains a smaller reporting company, allowing it to rely on certain exemptions from disclosure requirements[140].