On August 12, 2021 Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a precision oncology medicine company pioneering the discovery and development of small molecule, MasterKey therapies, reported financial results for the second quarter ended June 30, 2021 and provided a corporate update (Press release, Black Diamond Therapeutics, AUG 12, 2021, View Source [SID1234586466]).

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"We continue to advance our clinical and pre-clinical pipeline of MasterKey therapies, including BDTX-189, for which we expect to initiate the Phase 2 trial in the second half of this year. Our early-stage programs continue to advance as well, and we look forward to submitting Investigational New Drug (IND) applications for our BDTX-1535, BRAF (B-Raf), and fibroblast growth factor receptor (FGFR) programs in 2022," said David M. Epstein, Ph.D., President and Chief Executive Officer of Black Diamond Therapeutics. "We remain committed to the discovery and development of novel precision medicine therapies to address genetically defined cancers with unmet medical need."

Recent Developments

BDTX-189:

Black Diamond completed the Phase 1 dose-escalation portion of the MasterKey-01 study, a Phase 1/2 clinical trial of BDTX-189. The Company has selected the preliminary recommended Phase 2 dose for BDTX-189 and, pending dialogue with the U.S. Food and Drug Administration (FDA), is on track to initiate the Phase 2 portion of the study in the second half of 2021.
In May 2021, Black Diamond presented initial clinical pharmacokinetic (PK), safety, and preliminary efficacy data from the Phase 1 dose-escalation portion of the MasterKey-01 study of BDTX-189 in advanced solid tumors at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting:
BDTX-189 was generally well-tolerated with medically manageable toxicities observed.
Preliminary anti-cancer activity was observed in a heavily pre-treated patient population (prior epidermal growth factor receptor (EGFR)-/human epidermal growth factor receptor 2 (HER2)-directed and/or immuno-oncology (I/O) agents) in a variety of tumor types and genomic alterations in EGFR or HER2, including confirmed partial responses.
BDTX-1535:

Black Diamond continues to advance BDTX-1535 through IND-enabling studies and expects to file an IND application in the first half of 2022.
In April 2021, the Company presented pre-clinical data on BDTX-1535 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting:
BDTX-1535 demonstrated a favorable brain-penetrant PK profile in mouse, rat, and dog models, and tumor growth inhibition in mouse models bearing intracranial GBM6 patient-derived tumors expressing allosteric EGFR mutants was achieved.
BDTX-1535 demonstrated potent and selective inhibition of rare Exon 18 mutations and the C797S mutation, supporting the potential for utility beyond glioblastoma (GBM), such as in non-small cell lung cancer (NSCLC).
Early-Stage Pipeline:

Black Diamond continues to progress its early-stage pipeline programs designed to target cancers driven by mutations in BRAF and FGFR. The Company anticipates IND filings for the BRAF and FGFR programs in 2022.
Corporate:

In August 2021, Black Diamond announced the appointment of Elizabeth Buck, Ph.D., as Chief Scientific Officer and Karsten Witt, M.D., as Interim Chief Medical Officer. Additionally, the Company announced the departures of Rachel Humphrey, M.D., the Company’s Chief Medical Officer, and Christopher Roberts, Ph.D., the Company’s Chief Scientific Officer.
In August 2021, Black Diamond appointed Mark Velleca, M.D., Ph.D., to its Board of Directors.
Financial Highlights

Black Diamond ended the second quarter of 2021 with $263.5 million in cash, cash equivalents, and investments compared to $345.0 million as of June 30, 2020. Net cash used in operations was $25.2 million for the second quarter of 2021 compared to $24.9 million for the second quarter of 2020.
Research and development (R&D) expenses were $26.7 million for the second quarter of 2021 compared to $10.2 million for the second quarter of 2020. The increase in R&D expenses was primarily related to an increase in headcount and increased spend across preclinical and clinical development.
General and administrative (G&A) expenses were $8.0 million for the second quarter of 2021 compared to $4.9 million for the second quarter of 2020. The increase in G&A expenses was primarily due to an increase in personnel and other corporate-related costs.