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CAMBRIDGE, Mass. and NEW YORK, May 09, 2023 (GLOBE NEWSWIRE) -- Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage precision oncology medicine company developing MasterKey therapies designed to overcome limitations of existing therapies by targeting families of oncogenic driver mutations in patients with genetically defined cancers, today reported financial results for the first quarter ended March 31, 2023, and provided a corporate update.
“We are incredibly pleased with the pace of execution since the start of 2023 as we continue to advance our pipeline programs, BDTX-1535 and BDTX-4933 in addition to our newest program, BDTX-4876. Having three investigational new drug (IND) acceptances in three years is exemplary of our breadth of expertise in precision oncology drug discovery and development. We are confident that our momentum will continue to bring tremendous progress across our pipeline as we head further into this transformational year for Black Diamond,” said David Epstein, Ph.D., President and Chief Executive Officer of Black Diamond Therapeutics. “2023 brings several key inflection points, including a clinical update from the dose-escalation portion of our Phase 1 trial of BDTX-1535 in patients with non-small cell lung cancer (NSCLC) and glioblastoma multiforme (GBM), the initiation of a Phase 1 clinical trial for BDTX-4933, and today’s announcement of a development candidate nomination for our fibroblast growth factor receptor (FGFR) 2/3 selective program. We remain acutely focused on bringing our next-generation precision medicines to patients in need, particularly as we work to expand the addressable patient population within the broader oncogenic mutation landscape. Our sophisticated drug design and our deep-rooted commitment to effectively targeting shared, activated conformations used by oncogenic drivers for tumor growth are all enabled by our Mutation Allostery Pharmacology (MAP) drug discovery engine and ultimately realized by our MasterKey therapies.”
Recent Developments & Upcoming Milestones:
BDTX-1535:
BDTX-4933:
Discovery-Stage Pipeline and MAP Drug Discovery Engine:
Corporate:
Financial Highlights
Financial Guidance
About Black Diamond Therapeutics
Black Diamond Therapeutics is a clinical-stage precision oncology medicine company focused on the development of MasterKey therapies that target families of oncogenic mutations in clinically validated targets. Black Diamond leverages a deep understanding of cancer genetics and onco-protein structure and function, to discover and develop innovative MasterKey therapies. The Company’s MasterKey therapies are designed to overcome resistance, minimize on-target, wild-type mediated toxicities, and be brain-penetrant to address significant unmet medical needs of patients with genetically defined cancers. The Company is advancing a robust pipeline with lead clinical-stage program BDTX-1535, targeting MasterKey mutations in both EGFR mutant-positive NSCLC and in GBM, and BDTX-4933, a program targeting RAF MasterKey mutations in solid tumors, as well as discovery-stage research programs. The Company’s proprietary MAP drug discovery engine is designed to allow Black Diamond to analyze population-level genetic sequencing tumor data and validate MasterKey mutations. For more information, please visit www.blackdiamondtherapeutics.com.
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because 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, statements regarding: the continued development and advancement of BDTX-1535, and BDTX-4933, including the ongoing Phase 1 clinical trial and the expected timing for data updates for BDTX-1535 and the timing for initiating a Phase 1 clinical trial of BDTX-4933, the continued development of the FGFR program, exploring strategic alternatives for the FGFR program, the continued development of the MAP drug discovery engine 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 a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include those risks and uncertainties set forth in its Annual Report on Form 10-K for the year ended December 31, 2022, filed with the United States Securities and Exchange Commission and in its subsequent filings filed with the United States Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
| Black Diamond Therapeutics, Inc. | |||||||
| Condensed Consolidated Balance Sheet Data (Unaudited) | |||||||
| (in thousands) | |||||||
| March 31, 2023 | December 31, 2022 | ||||||
| (in thousands) | |||||||
| Cash, cash equivalents, and investments | $ | 103,366 | $ | 122,807 | |||
| Total assets | $ | 135,582 | $ | 156,255 | |||
| Accumulated deficit | $ | (355,864 | ) | $ | (334,989 | ) | |
| Total stockholders’ equity (deficit) | $ | 98,190 | $ | 115,695 | |||
| Black Diamond Therapeutics, Inc. | |||||||
| Consolidated Statements of Operations (Unaudited) | |||||||
| (in thousands, except per share data) | |||||||
| Three Months Ended March 31, | |||||||
| 2023 | 2022 | ||||||
| Operating expenses: | |||||||
| Research and development | $ | 14,753 | $ | 17,786 | |||
| General and administrative | 6,808 | 7,893 | |||||
| Total operating expenses | 21,561 | 25,679 | |||||
| Loss from operations | (21,561 | ) | (25,679 | ) | |||
| Other income (expense): | |||||||
| Interest income | 622 | 406 | |||||
| Other income (expense) | 64 | (234 | ) | ||||
| Total other income (expense), net | 686 | 172 | |||||
| Net loss | $ | (20,875 | ) | $ | (25,507 | ) | |
| Net loss per share, basic and diluted | $ | (0.57 | ) | $ | (0.70 | ) | |
| Weighted average common shares outstanding, basic and diluted | 36,483,878 | 36,271,291 | |||||
Contact:
Julie Seidel, Stern Investor Relations
(212) 362-1200
investors@bdtx.com
media@bdtx.com