On August 6, 2024 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 second quarter ended June 30, 2024, and provided a corporate update (Press release, Black Diamond Therapeutics, AUG 6, 2024, View Source [SID1234645411]).

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"We continue to execute on enrollment of patients with EGFR mutant NSCLC into second/third-line and first-line Phase 2 cohorts, and remain on track to announce initial results later in the third quarter of this year and in the first quarter of 2025, respectively", said Mark Velleca, M.D., Ph.D., Chief Executive Officer of Black Diamond Therapeutics. "We also look forward to sharing analyses of real world data at the 2024 ESMO (Free ESMO Whitepaper) Congress in September 2024 on treatment practices and therapeutic outcomes for newly diagnosed NSCLC patients with non-classical EGFR mutations that demonstrate a significant unmet medical need."

Recent Developments & Upcoming Milestones:

BDTX-1535:

In April 2024, Black Diamond described real world evidence of the evolving EGFR mutation landscape in patients with non-small cell lung cancer (NSCLC) and the potential of BDTX-1535 to address a broader range of mutations compared to existing therapies at the 2024 American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting. The analyses revealed a spectrum of previously underappreciated non-classical mutations, as well as an increased prevalence of the acquired resistance mutation C797S. These non-classical EGFR mutations were present in 20-30% of newly diagnosed epidermal growth factor receptor mutation positive (EGFRm) NSCLC patients.
In June 2024, Black Diamond presented additional data from the Phase 1 dose escalation trial of BDTX-1535 in patients with relapsed/recurrent glioblastoma (GBM), and initial intratumoral pharmacokinetic data from a "window of opportunity" (also known as a Phase 0/1 "Trigger") trial sponsored by the Ivy Brain Tumor Center, in patients with recurrent high-grade glioma (HGG), at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. Safety and tolerability data in the Phase 1 trial were consistent with BDTX-1535 clinical data in patients with NSCLC previously presented in October 2023 at the European Organization for Research and Treatment of Cancer-National Cancer Institute-American Association for Cancer Research (AACR-NCI-EORTC) (Free AACR-NCI-EORTC Whitepaper) AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper). Among 19 efficacy evaluable patients, several experienced stable disease with promising durability. Results from the investigator-sponsored trial demonstrated that BDTX-1535 penetrates the blood brain barrier with clinically meaningful unbound drug concentration in gadolinium non-enhancing regions of the brain and inhibition of corresponding pharmacodynamic markers. Eight out of nine patients exceeded the pre-specified threshold for drug concentration in the brain tumor tissue and continued on study.
Black Diamond anticipates the following upcoming key milestones for BDTX-1535:
Disclosure of initial Phase 2 data in 2L/3L EGFRm NSCLC patients with non-classical mutations or the acquired resistance C797S mutation remains on track for later in Q3 2024.
Disclosure of initial Phase 2 data in 1L EGFRm NSCLC patients with non-classical mutations remains on track for Q1 2025 (NCT05256290).
An abstract has been accepted for presentation at the 2024 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress titled "Real World Evidence of Treatment Practices and Therapeutic Outcomes for Newly Diagnosed NSCLC Patients with Non-classical EGFR Mutations Demonstrates High Unmet Medical Need", which will detail an analysis of Guardant Inform data on treatment outcomes for newly diagnosed NSCLC patients with tumors expressing non-classical mutations.
BDTX-4933:

BDTX-4933 is a brain-penetrant oral inhibitor of oncogenic alterations in KRAS, NRAS and BRAF.
Enrollment of patients with BRAF and select RAS/MAPK mutation-positive cancers, with an emphasis on patients with KRAS mutant NSCLC, is progressing through escalating doses in a Phase 1 trial (NCT05786924). An update from this trial is on track for Q4 2024.
Corporate

Chief Business Officer & Chief Financial Officer, Fang Ni, Pharm.D, will participate in a panel discussion at the Wedbush PacGrow Healthcare Conference taking place August 13-14, 2024, in New York, NY.
Financial Highlights

Cash Position: Black Diamond ended the second quarter of 2024 with approximately $123.0 million in cash, cash equivalents, and investments compared to $131.4 million as of December 31, 2023. Net cash used in operations was $14.7 million for the second quarter of 2024 compared to $14.4 million for the second quarter of 2023.
Research and Development Expenses: Research and development (R&D) expenses were $12.6 million for the second quarter of 2024, compared to $13.2 million for the same period in 2023. The decrease in R&D expenses was primarily due to workforce efficiencies and reduced spending on early discovery projects.
General and Administrative Expenses: General and administrative (G&A) expenses were $9.6 million for the second quarter of 2024, compared to $6.9 million for the same period in 2023. The increase in G&A expenses was primarily due to an increase in consulting and other professional fees.
Net Loss: Net loss for the second quarter of 2024 was $19.9 million, as compared to $19.2 million for the same period in 2023.
Financial Guidance

Black Diamond ended the second quarter of 2024 with approximately $123.0 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 2025.