Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with cancer, today reported financial results for the first quarter ended March 31, 2025, and provided a corporate update.

"We continue to execute on enrollment in our BDTX-1535 Phase 2 trial for the treatment of newly diagnosed patients with EGFRm NSCLC and look forward to providing a clinical update in the fourth quarter of 2025," said Mark Velleca, M.D., Ph.D., President and Chief Executive Officer of Black Diamond Therapeutics. "Our recently announced global licensing agreement with Servier for BDTX-4933 provides us with a strong cash position and runway into the fourth quarter of 2027. Pending FDA feedback in the fourth quarter of 2025, we believe we are well-positioned to begin pivotal development of BDTX-1535 in the first half of 2026.".

Recent Developments & Upcoming Milestones:

BDTX-1535:

In the fourth quarter of 2025, Black Diamond expects to disclose initial Phase 2 clinical data for BDTX-1535 in newly diagnosed patients with non-classical epidermal growth factor receptor mutant (EGFRm) non-small cell lung cancer (NSCLC) (NCT05256290) and plans to solicit U.S. Food and Drug Administration (FDA) feedback on a potential pivotal registrational path.

In April 2025, investigators at the Ivy Brain Tumor Center presented a poster at the American Association for Cancer Research (AACR) Annual Meeting titled: A Phase 0/1 'trigger' trial of BDTX-1535 in recurrent glioblastoma (GBM) patients with EGFR alterations or fusions. The data showed encouraging pharmacokinetic and safety data for BDTX-1535 in recurrent EGFR-positive GBM patients, providing a strong rationale for the program’s continued expansion into newly diagnosed EGFR-positive GBM patients.

In March 2025, the investigator sponsored Phase 0/1 trial was expanded into newly diagnosed GBM patients with epidermal growth factor receptor (EGFR) alterations. The trial is sponsored by the Ivy Brain Tumor Center in Phoenix, Arizona (NCT06072586). 

Corporate

In March 2025, Black Diamond announced a global licensing agreement with Servier Pharmaceuticals LLC (Servier) for BDTX-4933, a small molecule designed by Black Diamond to address unmet medical needs in RAF/RAS-mutant solid tumors. Pursuant to the terms of the agreement, Servier will lead the development activities and the worldwide commercialization of BDTX-4933 across multiple indications, including NSCLC, with potential applications in other solid tumors. Under the agreement, Black Diamond received an upfront payment of $70.0 million in March 2025 and will be eligible to receive up to $710.0 million in development and commercial sales milestone payments, along with tiered royalties based on global net sales.

Financial Highlights

Cash Position: Black Diamond ended the first quarter of 2025 with approximately $152.4 million in cash, cash equivalents, and investments compared to $98.6 million as of December 31, 2024. Net cash provided by operations was $53.4 million for the first quarter of 2025 compared to net cash used in operations of $21.2 million for the first quarter of 2024.

Research and Development Expenses: Research and development (R&D) expenses were $10.5 million for the first quarter of 2025, compared to $13.5 million for the same period in 2024. 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 $5.0 million for the first quarter of 2025, compared to $6.7 million for the same period in 2024. The decrease in G&A expenses was primarily due to the restructuring announced in October 2024.

Net Income/Loss: Net income for the first quarter of 2025 was $56.5 million, as compared to a net loss of $18.2 million for the same period in 2024.

Financial Guidance

Black Diamond ended the first quarter of 2025 with approximately $152.4 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 2027.

About Black Diamond Therapeutics

Black Diamond Therapeutics is a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with cancer. The Company’s MasterKey therapies are designed to address a broad spectrum of genetically defined tumors, overcome resistance, minimize wild-type mediated toxicities, and be brain penetrant to treat central nervous system disease. The Company is advancing a Phase 2 NSCLC trial of BDTX-1535, a brain-penetrant fourth-generation EGFR MasterKey inhibitor targeting EGFR-mutant NSCLC and GBM. For more information, please visit www.blackdiamondtherapeutics.com.

Black Diamond Therapeutics Reports First Quarter 2025 Financial Results and Provides Corporate Update

Black Diamond Therapeutics, a clinical-stage oncology company, reported first-quarter 2025 financial results, including a net income of $56.5 million, and provided updates on its Phase 2 trial for BDTX-1535 and a global licensing agreement with Servier for BDTX-4933. The company highlighted progress in clinical trials, a strong cash position, and upcoming regulatory feedback.