Black Diamond Therapeutics Reports Third Quarter 2024 Financial Results and Provides Corporate Update

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]