Black Diamond Therapeutics Q1 2024 Financial Results and Corporate Update

Black Diamond Therapeutics, Inc., a clinical-stage oncology company focused on developing therapies to target oncogenic mutations, has announced its financial results for Q1 2024 and provided significant updates on its ongoing projects.

CEO Mark Velleca highlighted the company's recent progress, particularly the initiation of dosing patients with non-classical EGFR mutant NSCLC in the first-line setting. The company aims to release initial results from this Phase 2 trial in Q3 2024. The recent AACR presentation elucidated the substantial unmet needs and the innovative profile of BDTX-1535, a potential fourth-generation oral TKI, which is designed to target a variety of EGFR mutations including classical, non-classical, and C797S resistance mutations in NSCLC.

Black Diamond has reported several key milestones and future plans. Following feedback from the FDA at the end of Phase 1, Black Diamond has started dosing a Phase 2 first-line cohort for patients with non-classical EGFRm NSCLC as of early 2024. This trial is registered under NCT05256290. In April 2024, a detailed presentation at the AACR annual meeting shared real-world evidence on the evolving mutation landscape in NSCLC and highlighted the extensive capabilities of BDTX-1535 in addressing these mutations. The data covered over 235,000 sequenced NSCLC cases, revealing a significant portion of newly diagnosed cases displaying non-classical mutations.

Upcoming key milestones include poster presentations at the ASCO Annual Meeting on June 1, 2024, focusing on Phase 1 dose escalation data in patients with relapsed/recurrent GBM and initial pharmacokinetic results from a "window of opportunity" trial in recurrent high-grade glioma patients. Additionally, the initial Phase 2 results for 2L/3L EGFRm NSCLC patients with non-classical or C797S mutations are expected in Q3 2024.

In parallel, Black Diamond continues to advance its other clinical program, BDTX-4933. This drug, an oral inhibitor targeting KRAS, NRAS, and BRAF mutations, is currently in a Phase 1 dose escalation trial for patients with BRAF and select RAS/MAPK mutation-positive cancers, with a focus on KRAS mutant NSCLC. An update from this trial is anticipated in Q4 2024.

Corporate developments include the addition of Shannon Campbell and Prakash Raman, Ph.D., to the Board of Directors, while Wendy Dixon, Ph.D., and Alex Mayweg, Ph.D., have stepped down.

From a financial perspective, Black Diamond ended Q1 2024 with $115.2 million in cash, cash equivalents, and investments. This compares to $131.4 million at the end of 2023. The net cash used in operations during this quarter was $21.2 million, compared to $20.0 million in Q1 2023. Research and development expenses were slightly reduced to $13.5 million from $14.8 million in the previous year, primarily due to lower spending on early discovery projects. General and administrative expenses remained stable at $6.7 million. The net loss for the first quarter stood at $18.2 million, a decrease from $20.9 million in Q1 2023.

Black Diamond's financial projections indicate that its current funds should cover operational expenses and capital requirements until the third quarter of 2025. The company remains committed to advancing its clinical-stage programs and addressing the critical needs of cancer patients through its innovative therapies.