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Black Diamond Therapeutics(BDTX) - 2024 Q3 - Quarterly Results
2024-11-05 12:01
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: EGFRm NSCLC Targeting Continues With Q1 Of 2025 Data
Seeking Alpha· 2024-10-08 19:24
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 ...
Black Diamond Therapeutics Announces Restructuring Plan to Focus Resources on BDTX-1535 and Extend Cash Runway
GlobeNewswire News Room· 2024-10-07 20:01
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 ...
Black Diamond Therapeutics Announces Initial Phase 2 Data Demonstrating Robust Anti-tumor Activity of BDTX-1535 in Patients with Recurrent EGFRm NSCLC who Present with a Broad Spectrum of Classical, Non-classical, and C797S Resistance Mutations
GlobeNewswire News Room· 2024-09-23 11:00
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 ...
Black Diamond Therapeutics to Host Webcast Presentation of Initial Phase 2 BDTX-1535 Data in Patients With Recurrent EGFRm NSCLC
GlobeNewswire News Room· 2024-09-22 14:00
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]
Black Diamond Therapeutics Presents Real-World Treatment Practices and Patient Outcomes in Newly Diagnosed NSCLC Patients with Non-Classical Mutations at the European Society for Medical Oncology (ESMO) Congress 2024
GlobeNewswire News Room· 2024-09-14 07:30
Treatment data were analyzed from 3,276 cases of patients with newly diagnosed EGFR mutant NSCLC from Guardant Health Analyses of patients with non-classical EGFR mutations reveal that the majority receive frontline chemotherapy and the remainder are treated with osimertinib or afatinib Short time to treatment discontinuation ranging from four to eight months demonstrates clear unmet need for patients with non-classical EGFR mutant NSCLC CAMBRIDGE, Mass., Sept. 14, 2024 (GLOBE NEWSWIRE) -- Black Diamond The ...
All You Need to Know About Black Diamond (BDTX) Rating Upgrade to Buy
ZACKS· 2024-08-08 17:01
Core Viewpoint - Black Diamond (BDTX) has been upgraded to a Zacks Rank 2 (Buy), indicating a positive shift in earnings estimates which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Price Impact - The Zacks rating system reflects changes in earnings estimates, which are strongly correlated with near-term stock price movements [4][6]. - An increase in earnings estimates typically leads to higher fair value calculations by institutional investors, resulting in stock price movements [4]. Business Outlook - The upgrade suggests an improvement in Black Diamond's underlying business, which should encourage investors to drive the stock price higher [5][10]. - The Zacks Consensus Estimate for Black Diamond indicates expected earnings of -$1.43 per share for the fiscal year ending December 2024, representing a year-over-year change of 23.9% [8]. Zacks Rating System - The Zacks Rank system classifies stocks based on earnings estimates into five groups, with Zacks Rank 1 (Strong Buy) stocks historically generating an average annual return of +25% since 1988 [7]. - Black Diamond's upgrade to Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, suggesting potential for market-beating returns in the near term [10].
Black Diamond Therapeutics Reports Second Quarter 2024 Financial Results and Provides Corporate Update
GlobeNewswire News Room· 2024-08-06 11:30
Initial Phase 2 data of BDTX-1535 in 2L/3L patients with EGFRm NSCLC on track for later in Q3 2024 On track to announce initial Phase 2 data of BDTX-1535 in 1L patients with non-classical EGFRm NSCLC in Q1 2025, and initial Phase 1 data of BDTX-4933 in KRASm NSCLC in Q4 2024 Upcoming poster presentation at 2024 ESMO Congress in September, titled "Real World Evidence of Treatment Practices and Therapeutic Outcomes for Newly Diagnosed NSCLC Patients with Non-classical EGFR Mutations Demonstrates High Unmet Me ...
Black Diamond Therapeutics(BDTX) - 2024 Q2 - Quarterly Report
2024-08-06 11:04
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, 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 NUMBE ...
Black Diamond Therapeutics(BDTX) - 2024 Q2 - Quarterly Results
2024-08-06 11:00
Black Diamond Therapeutics Reports Second Quarter 2024 Financial Results and Provides Corporate Update • Initial Phase 2 data of BDTX-1535 in 2L/3L patients with EGFRm NSCLC on track for later in Q3 2024 • On track to announce initial Phase 2 data of BDTX-1535 in 1L patients with non-classical EGFRm NSCLC in Q1 2025, and initial Phase 1 data of BDTX-4933 in KRASm NSCLC in Q4 2024 • Upcoming poster presentation at 2024 ESMO Congress in September, titled "Real World Evidence of Treatment Practices and Therape ...