Financial Performance - Black Diamond ended 2024 with approximately $98.6 million in cash, cash equivalents, and investments, down from $131.4 million as of December 31, 2023[4]. - Net cash used in operations for the year ended December 31, 2024, was $62.3 million, compared to $66.7 million for the year ended December 31, 2023[4]. - Total operating expenses for the year ended December 31, 2024, were $78.8 million, down from $86.5 million in 2023, reflecting a reduction of 8.0%[15]. - Net loss for Q4 2024 was $16.0 million, compared to a net loss of $19.4 million for the same period in 2023, representing a 17.5% improvement[10]. - The accumulated deficit increased to $487.1 million as of December 31, 2024, from $417.4 million in 2023[13]. Research and Development - Research and development expenses for Q4 2024 were $12.3 million, a decrease of 19.5% from $15.3 million in Q4 2023[10]. - Black Diamond anticipates initial Phase 2 clinical data for BDTX-1535 in newly diagnosed patients with non-classical EGFRm NSCLC in Q2 2025[5]. - The company plans to solicit FDA feedback on a potential pivotal registrational path for BDTX-1535 in the second half of 2025[6]. - The expansion of the investigator-sponsored "window of opportunity" trial into newly diagnosed glioblastoma patients is expected in Q1 2025[5]. Cash Position - Black Diamond's cash position is expected to be sufficient to fund operations into Q4 2026[7].

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].

Financial Performance - Black Diamond Therapeutics reported a net loss of $15.6 million for Q3 2024, compared to a net loss of $23.0 million in Q3 2023, representing a 32.6% improvement[6]. - Cash, cash equivalents, and investments totaled approximately $112.7 million as of September 30, 2024, down from $131.4 million at the end of 2023[6][10]. - Total operating expenses for Q3 2024 were $18.1 million, down from $24.0 million in Q3 2023, reflecting a 24.6% decrease[11]. Research and Development - Research and development expenses decreased to $12.9 million in Q3 2024 from $16.2 million in Q3 2023, a reduction of 20.3%[6][11]. - The overall response rate (ORR) for BDTX-1535 in patients with osimertinib-resistant EGFR mutations was reported at 42%[3]. - The duration of response (DOR) for the first three patients achieving a partial response was approximately eight months or more[3]. - 36% of newly diagnosed NSCLC patients with non-classical EGFR mutations received osimertinib or afatinib, while 60% received chemotherapy and/or immunotherapy[3]. - Black Diamond plans to provide clinical updates on BDTX-1535 in Q1 2025, including feedback on a registrational path from the FDA[2][4]. Strategic Initiatives - The company expects its cash runway to extend into Q2 2026, following a corporate restructuring plan aimed at optimizing development resources[5][7]. - Black Diamond is actively seeking partnerships for its deprioritized Phase 1 RAS/RAF inhibitor, BDTX-4933[5].

Black Diamond Therapeutics (NASDAQ: BDTX ) is gearing up to report initial results from its phase 2 study using BDTX-1535 targeting 1st-line EGFR mutant non-small cell lung cancer [NSCLC] patients in Q1 of 2025. There might also be an additional update of data He is the author of the investing group Biotech Analysis Central which contains a library of 600+ Biotech investing articles, a model portfolio of 10+ small and mid-cap stocks with deep analysis for each, live chat, and a range of analysis and news re ...

Company advancing BDTX-1535 in EGFRm NSCLC towards key inflection points in Q1 2025 Will deprioritize BDTX-4933 and seek potential partners Anticipated cost savings expected to extend cash runway into Q2 2026 CAMBRIDGE, Mass., Oct. 07, 2024 (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, announced today a corporate restructuring to focus resources on adva ...

BDTX-1535 dose of 200 mg daily selected for pivotal development; favorable tolerability profile and no new safety signals observed Preliminary ORR of 42% in 19 patients at 200 mg with on-target resistance EGFR mutations Encouraging durability with DOR of approximately 8 months or more for first 3 patients with a PR; 14 of 19 patients remain on treatment Regulatory feedback on registration path anticipated in Q1 2025 Initial results of BDTX-1535 in first-line NSCLC patients with non-classical EGFR mutations ...

Core Insights - Black Diamond Therapeutics is set to disclose initial phase 2 clinical trial results for BDTX1535 targeting recurrent EGFRm NSCLC on September 23, 2024 [1] - The company specializes in developing MasterKey therapies aimed at oncogenic mutations in cancer patients [3] Company Overview - Black Diamond Therapeutics is a clinical-stage oncology company focused on MasterKey therapies that target genetically defined tumors [3] - The company is advancing two clinical-stage programs: BDTX-1535, a fourth-generation EGFR MasterKey inhibitor for EGFR mutant NSCLC and GBM, and BDTX-4933, a RAF MasterKey inhibitor for KRAS, NRAS, and BRAF alterations in solid tumors [3]