On March 6, 2025 Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with cancer, reported financial results for the fourth quarter and full year ended December 31, 2024, and provided a corporate update (Press release, Black Diamond Therapeutics, MAR 6, 2025, View Source [SID1234650947]).

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"We continue to focus on advancing BDTX-1535 for the treatment of patients with EGFRm NSCLC and providing a clinical update on our Phase 2 trial for newly diagnosed patients in the second quarter of 2025," said Mark Velleca, M.D., Ph.D., President and Chief Executive Officer of Black Diamond Therapeutics. "We also look forward to the expansion in the first quarter of 2025 of the investigator sponsored window of opportunity trial of BDTX-1535 into newly diagnosed glioblastoma patients with EGFR aberrations, an area of high unmet medical need."
Recent Developments & Upcoming Milestones:

BDTX-1535:

Black Diamond anticipates the following upcoming key milestones for BDTX-1535:

•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.
•Planning to solicit U.S. Food and Drug Administration (FDA) feedback on a potential pivotal registrational path for BDTX-1535 in newly diagnosed EGFRm NSCLC patients in the second half of 2025.
•Expansion of the investigator sponsored "window of opportunity" trial (also known as a Phase 0/1 "Trigger" trial) into a Phase 0/2 trial in newly diagnosed glioblastoma (GBM) patients with epidermal growth factor receptor (EGFR) aberrations in the first quarter of 2025. The trial is sponsored by the Ivy Brain Tumor Center in Phoenix, Arizona (NCT06072586).
Financial Highlights
•Cash Position: Black Diamond ended 2024 with approximately $98.6 million in cash, cash equivalents, and investments compared to $131.4 million as of December 31, 2023. Net cash used in operations was $62.3 million for the year ended December 31, 2024 compared to $66.7 million for the year ended December 31, 2023.

•Research and Development Expenses: Research and development (R&D) expenses were $12.3 million for the fourth quarter of 2024, compared to $15.3 million for the same period in 2023. Research and development expenses were $51.3 million for the year ended December 31, 2024, compared to $59.4 million for the year ended December 31, 2023. The decrease in R&D expenses was primarily due to workforce efficiencies and increased focus on advancing and optimizing development plans for BDTX-1535.
•General and Administrative Expenses: General and administrative (G&A) expenses were $6.0 million for the fourth quarter of 2024, compared to $5.6 million for the same period in 2023, and $27.5 million for the year ended December 31, 2024, compared to $27.1 million for the year ended December 31, 2023. The increase in G&A expenses was primarily related to one-time restructuring costs.
•Net Loss: Net loss for the fourth quarter of 2024 was $16.0 million, as compared to $19.4 million for the same period in 2023. Net loss for the year ended December 31, 2024 was $69.7 million compared to $82.4 million for the year ended December 31, 2023.
Financial Guidance
•Black Diamond ended 2024 with approximately $98.6 million in cash, cash equivalents and investments which the Company believes is sufficient to fund its anticipated operating expenses and capital expenditure requirements into the fourth quarter of 2026.