Black Diamond Therapeutics Restructures to Prioritize BDTX-1535 and Extend Funds

Black Diamond Therapeutics, Inc., a clinical-stage oncology company, announced a strategic restructuring to prioritize the advancement of its lead program, BDTX-1535. This decision aims to extend the company's cash runway into the second quarter of 2026. The primary focus is on developing BDTX-1535, which has shown promising results in Phase 2 clinical trials for patients with recurrent non-small cell lung cancer (NSCLC) carrying epidermal growth factor receptor mutations (EGFRm).

The company anticipates sharing initial Phase 2 data for BDTX-1535 in the first quarter of 2025. This data will focus on the treatment of patients with EGFRm NSCLC in the frontline setting. Furthermore, Black Diamond plans to present updated Phase 2 results for recurrent EGFRm NSCLC, incorporating potential registration pathways based on feedback from the U.S. Food and Drug Administration (FDA).

In a bid to concentrate resources on BDTX-1535, Black Diamond is deprioritizing its BDTX-4933 program, targeting RAF/RAS-mutant solid tumors. The company is actively seeking potential partners for this program. Additionally, Black Diamond has implemented operational optimizations, including a workforce reduction, while retaining essential drug development and management expertise.

As part of the restructuring, several key personnel changes have been made. Chief Business Officer and Chief Financial Officer Fang Ni, along with Chief People Officer Elizabeth Montgomery, are departing the company. Erika Jones, Senior Vice President of Finance and Principal Accounting Officer, has been appointed as the new Principal Financial Officer.

The anticipated cost savings from these actions are expected to fund Black Diamond's operations into the second quarter of 2026.

BDTX-1535 is an oral, brain-penetrant MasterKey inhibitor designed to target a variety of oncogenic EGFR mutations in NSCLC, including classical, non-classical, and the C797S resistance mutations. This fourth-generation tyrosine kinase inhibitor (TKI) has demonstrated potent inhibition of over 50 EGFR mutations. It is currently undergoing a Phase 2 trial for NSCLC and a "window of opportunity" trial for glioblastoma (GBM).

Dr. Mark Velleca, Chief Executive Officer of Black Diamond Therapeutics, emphasized the importance of BDTX-1535, describing it as a well-tolerated oral TKI with significant potential for patients with EGFRm NSCLC across various lines of therapy. He expressed gratitude to the Black Diamond team for their contributions, which have positioned the company at the cusp of pivotal development for its lead program.

Black Diamond Therapeutics is dedicated to developing MasterKey therapies that target families of oncogenic mutations in cancer patients. These therapies are designed to address a wide range of genetically defined tumors, overcome resistance, minimize toxicities associated with wild-type forms, and penetrate the brain to treat central nervous system diseases. The company's focus on BDTX-1535 highlights its commitment to advancing innovative treatments for NSCLC and GBM.