On August 9, 2022 Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a precision oncology medicine company pioneering the discovery and development of MasterKey therapies, reported financial results for the second quarter ended June 30, 2022 and provided a corporate update (Press release, Black Diamond Therapeutics, AUG 9, 2022, View Source [SID1234617876]).

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"Black Diamond is well positioned for strong clinical and discovery execution with clear scientific and operational strategies laid out across our business. We are excited to have our newly appointed Chief Medical Officer, Dr. Sergey Yurasov, on board as we continue to progress our Phase 1 global study of BDTX-1535, with the goal of sharing a clinical update in 2023," said David Epstein, Ph.D., President and Chief Executive Officer of Black Diamond Therapeutics. "Our precision medicine approach to cancer treatment centers on our proprietary ability to identify drug families of oncogenic mutations. Our recent publication in the American Association for Cancer Research (AACR) (Free AACR Whitepaper)’s journal demonstrates this by revealing previously overlooked oncogenic mutations in HER2. This is a clear example of our Mutation-Allostery-Pharmacology (MAP) discovery engine at work, supporting the value of oncogenicity prediction, biological validation, protein conformation-based drug design and MasterKey inhibitor development against mutation families. There remains an unmet need for patients with genetically defined cancers and we believe that these key facets of our scientific approach have the potential to bolster the current precision cancer medicine landscape."

Recent Developments

BDTX-1535:

BDTX-1535 is designed to be a potent, selective, irreversible and brain-penetrant MasterKey inhibitor of epidermal growth factor receptor (EGFR) mutations expressed in glioblastoma multiforme (GBM) and resistance mutations in non-small cell lung cancer (NSCLC), including de novo resistance and acquired resistance to third generation EGFR inhibitors.
In April 2022, the first patient was dosed in the Phase 1 study of BDTX-1535 and the Company expects to provide a clinical update on BDTX-1535 in 2023.
BDTX-4933:

BDTX-4933 is designed to be a brain-penetrant BRAF inhibitor against families of Class I, II, and III canonical and non-canonical mutations being developed for the treatment of patients with or without brain tumors. BDTX-4933 is also designed to be highly selective and potent, with the ability to avoid paradoxical activation.
Black Diamond expects to submit an investigational new drug (IND) application for BDTX-4933 with the U.S. Food and Drug Administration (FDA) in the first half of 2023.
Discovery-Stage Pipeline and MAP Discovery Engine:

In May 2022, Black Diamond announced the publication of new computational and functional analyses, identifying 22 new oncogenic human epidermal growth factor receptor 2 (HER2) allosteric mutations that support the Mutation-Allostery-Pharmacology (MAP) discovery engine’s capabilities. The paper, titled, "Computational and Functional Analyses of HER2 Mutations Revealing Allosteric Activation Mechanisms and Altered Pharmacologic Effects" by Ishiyama et al. was published online by the American Association for Cancer Research (AACR) (Free AACR Whitepaper)’s Cancer Research Journal.
Black Diamond continues to leverage its MAP drug discovery engine to advance its discovery-stage pipeline and anticipates progressing its fibroblast growth factor receptor (FGFR) program towards development candidate nomination in 2022, in addition to disclosing a development candidate against a new target in 2023.
Corporate:

In June 2022, Black Diamond appointed Sergey Yurasov, M.D., Ph.D., as its Chief Medical Officer, bringing over 25 years of oncology drug development experience and regulatory expertise. Dr. Yurasov joined Black Diamond from Nuvation Bio, where he served as Chief Medical Officer and spearheaded multiple clinical development programs for oncology indications and small molecule programs.
Financial Highlights

Cash Position: Black Diamond ended the second quarter of 2022 with approximately $160.9 million in cash, cash equivalents, and investments compared to $209.8 million as of December 31, 2021. Net cash used in operations was $18.1 million for the second quarter of 2022 compared to $25.2 million for the second quarter of 2021.
Research and Development Expenses: Research and development (R&D) expenses were $16.2 million for the second quarter of 2022 compared to $26.7 million for the second quarter of 2021. The decrease in R&D expenses was primarily due to reduced activities on the BDTX-189 program and reduced spending on early discovery projects.
General and Administrative Expenses: General and administrative (G&A) expenses were $7.0 million for the second quarter of 2022, compared to $8.0 million for the second quarter of 2021.
Net Loss: Net loss for the second quarter of 2022 was $22.9 million, as compared to $34.4 million for the same period in 2021.
Financial Guidance

Following the Company’s pipeline prioritization and workforce realignment announcement in April 2022, Black Diamond has extended its cash runway, which is expected to be sufficient to fund its anticipated operating expenses and expenditure requirements into the third quarter of 2024.