Black Diamond continues to prepare to start the second phase of the BDTX-189 MasterKey-01 study this year
Preclinical data of BDTX-1535, BRAF and FGFR projects presented at the AACR-NCI-EORTC (ANE) International Conference
Established a strategic partnership with OpenEye to accelerate drug discovery through cloud-based molecular dynamics technology
As of September 30, 2021, cash, cash equivalents and investments of US$235 million are expected to be sufficient to fund operations in the second half of 2023
Cambridge, Massachusetts and New York, November 8, 2021 (Global News Agency)-Black Diamond Therapeutics, Inc. (NASDAQ: BDTX) is a pioneering company that discovers and develops the precision of MasterKey therapy Oncology, Inc., today reported its financial results for the third quarter ended September 30, 2021, and provided company updates.
"Black Diamond's approach remains deeply rooted in our proprietary mutation-almutation-pharmacology (MAP) drug discovery engine, which uses population-level gene sequencing to identify new cancer-causing mutations. Black Diamond Therapeutics President and Chief Executive Officer Executive Officer Dr. David Epstein said: "We are in a good position to promote a differentiated MasterKey program for a range of cancer-causing targets for patient groups whose needs are not met. "We are excited about the continued progress of our MasterKey inhibitor project pipeline, including the BDTX-189 MasterKey-01 study, our BDTX-1535 project is expected to submit an IND application in the first half of 2022, and our BRAF and fibroblasts Growth factor receptor (FGFR) program. "
Black Diamond is still preparing to start the Phase 2 part of the MasterKey-01 1/2 study of BDTX-189 by the end of 2021. The company has completed the phase 1 dose escalation part of the study and has selected the recommended phase 2 dose of BDTX-189.
Black Diamond continues to advance BDTX-1535 through IND-supported research and is expected to submit an IND application in the first half of 2022.
In October 2021, Black Diamond presented the preclinical data of BDTX-1535 at the ANE International Conference:
In cell-based testing, BDTX-1535 has achieved effective and selective inhibition of a series of EGFR mutations expressed in glioblastoma (GBM) and non-small cell lung cancer (NSCLC), including classic, non-classical and resistant Drug mutations, such as EGFR-C797S that may appear after treatment with osimertinib.
BDTX-1535 shows good brain penetration pharmacokinetics (PK) characteristics in mouse, rat and dog models.
In a series of tumor models, including the intercranial GBM model expressing targeted EGFR mutations and the lung cancer drug resistance model, BDTX-1535 showed dose-dependent tumor growth inhibition and achieved complete regression without significant effect on body weight.
Black Diamond continues to advance its early pipeline program, which aims to target cancers driven by BRAF and FGFR mutations. The company expects that these two projects will submit IND applications in 2022.
In October 2021, Black Diamond presented the preclinical data of the BRAF and FGFR projects at the ANE International Conference:
This presentation describes the preclinical data of a lead compound in the Black Diamond BRAF program, which aims to provide potency and selectivity for a series of non-classical class II/III mutations and class I mutations (V600E).
In the cell-based analysis, the lead compound showed effective inhibition of the BRAF class I/II/III mutation spectrum.
Compared with the current generation of BRAF inhibitors (such as encorafenib and vemurafenib), treatment of cells carrying wild-type BRAF (WT-BRAF) with the Black Diamond compound has not been observed to cause an increase in pERK, which is a contradictory activation signal.
In the BRAF-KIAA1549 fusion allograft tumor model, the lead compound showed dose-dependent pERK inhibition and anti-tumor efficacy.
This presentation explains the Black Diamond method, centered on a four-pronged optimization strategy, with the goal of providing an inhibitor that covers FGFR2 and FGFR3 oncogenes broadly, while retaining the inhibitory effect on FGFR1 and retaining the activity of resistant mutations .
In cell-based assays, FGFR program compounds showed effective and selective inhibition of a series of FGFR2/3 oncogenic mutations, while retaining FGFR1. In addition, FGFR program compounds show improved efficacy against drug resistance mutations.
In an in vivo study conducted in a UM-UC-14 (FGFR3-S249C) mouse model, the FGFR program compound showed anti-tumor activity. In addition, in mouse and rat models, FGFR program compounds do not promote hyperphosphatemia.
In September 2021, Black Diamond and OpenEye Scientific established a strategic partnership to incorporate OpenEye’s Orion® molecular design platform into Black Diamond’s proprietary mutation-allergic-pharmacology (MAP) drug discovery engine to help advance MasterKey inhibitors Cancer therapy. OpenEye's Orion software-as-a-service platform enables Black Diamond to quickly simulate and analyze protein movement.
Black Diamond's cash, cash equivalents and investments as of the third quarter of 2021 were US$235 million, compared to US$315.1 million as of December 31, 2020. Net cash used for operations in the third quarter of 2021 was US$26.5 million, compared with US$11.5 million in the third quarter of 2021. The third quarter of 2020.
Research and development (R&D) expenses in the third quarter of 2021 were US$27.6 million, compared with US$12.9 million in the third quarter of 2020. The increase in R&D expenses is mainly related to the increase in the number of employees and the increase in preclinical and clinical development expenditures.
General and administrative (G&A) expenses for the third quarter of 2021 were US$7.7 million, compared to US$5.6 million for the third quarter of 2020. The increase in G&A expenses was mainly due to the increase in personnel and other company-related costs.
About Black Diamond Therapeutics, Inc. Black Diamond Therapeutics is a precision oncology company that first discovered the MasterKey therapy. Black Diamond targets unmedicated mutations in genetically defined cancer patients. Black Diamond is built on an in-depth understanding of cancer genetics, protein structure and function, and medicinal chemistry. The company’s proprietary technology platform and drug discovery engine, the mutation-almutation-pharmacology (MAP) platform, aims to enable Black Diamond to analyze population-level gene sequencing data to identify carcinogens that promote cancer in different tumor types Mutations, divide these mutations into families, and develop a single small molecule therapy for specific mutation families, called MasterKey therapy. Black Diamond was founded by Dr. David M. Epstein and Dr. Elizabeth Buck. For more information, please visit www.blackdiamondtherapeutics.com. Forward-looking statements The statements contained in this press release regarding non-historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. As such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, the ongoing development of BDTX-189 and the timing of the initiation of the phase 2 part of the ongoing clinical trial of BDTX-189, the IND-supporting study of BDTX-1535, including expectations for IND submission, and BRAF and The development of the FGFR plan, including the time to submit the IND in each plan, and the company's expected cash runway. Any forward-looking statements in this statement are based on management’s current expectations of future events and are subject to many risks and uncertainties that may cause actual results to differ from those stated or implied in such forward-looking statements. The results have a material adverse effect. Risks that cause uncertainty in forward-looking statements include: the company’s candidate product development activities and the success of planned IND-supported research and clinical trials, cost and time, the company’s ability to execute its strategy, and regulatory development in the United States , The company’s ability to fund operations, the impact of the current COVID-19 pandemic on the company’s clinical trials and preclinical research, supply chain, and operations, as well as the listed risks and uncertainties in its submission to the US Securities and Exchange Commission. -K form in the 2020 annual report and other documents filed with the U.S. Securities and Exchange Commission. All forward-looking statements contained in this press release are issued only on the date they are made. The company assumes no obligation to update such statements to reflect events or existing circumstances after the date they are made.
Condensed consolidated balance sheet data (unaudited)
Cash, cash equivalents and investments
Condensed consolidated operating statement (unaudited)
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Total other income (expense), net
Net loss per share, basic and diluted
Weighted average issued common shares, basic shares and diluted shares
Investor: Natalie Wildenradt Investors@bdtx.com
Media: Kathy Vincent (310) 403-8951 media@bdtx.com
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