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CAMBRIDGE, Mass. and NEW YORK, March 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 fourth quarter and full year ended December 31, 2022, and provided a corporate update.
“We expect 2023 to be a catalyst rich year for Black Diamond following tremendous progress for our two novel MasterKey inhibitors, with BDTX-1535 continuing to advance through our Phase 1 clinical trial and BDTX-4933 meeting critical milestones to further progress toward the clinic. The clearance of the Investigational New Drug (IND) application for BDTX-4933 by the U.S. Food and Drug Administration (FDA) earlier this year marks our third IND allowance in three years and demonstrates the strength of our MAP drug discovery engine along with the expertise of our research and clinical teams. We are driven by the clear unmet need for next-generation precision medicines to treat cancers by overcoming resistance, minimizing on-target and wild-type mediated toxicities, and addressing brain disease. We’ve designed a robust pipeline of products with brain penetration properties to address these key challenges,” said David Epstein, Ph.D., President and Chief Executive Officer of Black Diamond. “We anticipate a clinical update for BDTX-1535 in the second half of 2023. We also expect to initiate the Phase 1 clinical trial of BDTX-4933 in the first half of this year and to progress our FGFR program and another undisclosed program toward development candidate nominations in 2023. As we continue to mature our pipeline, we are acutely focused on delivering meaningful benefit to patients and we believe that our approach has the potential to strengthen the treatment landscape for genetically defined cancers.”
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 non-small cell lung cancer (NSCLC) and in glioblastoma multiforme (GBM), and BDTX-4933, a program targeting RAF MasterKey mutations in solid tumors, as well as discovery-stage research programs. The Company’s proprietary Mutation-Allostery-Pharmacology, or 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 I clinical trial of BDTX-4933, the continued development of the FGFR program, including plans for nominating a development candidate, in addition to plans to disclose an additional development candidate against a new target, 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)
| December 31, | |||||||
| 2022 | 2021 | ||||||
| (in thousands) | |||||||
| Cash, cash equivalents, and investments | $ | 122,807 | $ | 209,786 | |||
| Total assets | $ | 156,255 | $ | 247,682 | |||
| Accumulated deficit | $ | (334,989 | ) | $ | (243,820 | ) | |
| Total stockholders’ equity (deficit) | $ | 115,695 | $ | 195,900 | |||
Black Diamond Therapeutics, Inc.
Consolidated Statements of Operations (Unaudited)
(in thousands, except per share data)
| Three Months Ended December 31, | Year Ended December 31, | ||||||||||||||
| 2022 | 2021 | 2022 | 2021 | ||||||||||||
| Operating expenses: | |||||||||||||||
| Research and development | $ | 14,609 | $ | 19,664 | $ | 64,437 | $ | 96,829 | |||||||
| General and administrative | 7,243 | 6,416 | 28,391 | 30,043 | |||||||||||
| Total operating expenses | 21,852 | 26,080 | 92,828 | 126,872 | |||||||||||
| Loss from operations | (21,852 | ) | (26,080 | ) | (92,828 | ) | (126,872 | ) | |||||||
| Other income (expense): | |||||||||||||||
| Interest income | 677 | 588 | 2,031 | 3,464 | |||||||||||
| Other income (expense) | 115 | (375 | ) | (354 | ) | (2,188 | ) | ||||||||
| Gain on sale of IP | 2,232 | — | 2,232 | — | |||||||||||
| Total other income (expense), net | 3,024 | 213 | 3,909 | 1,276 | |||||||||||
| Equity in (losses) of unconsolidated entity | (2,250 | ) | — | (2,250 | ) | — | |||||||||
| Net loss | $ | (21,078 | ) | $ | (25,867 | ) | $ | (91,169 | ) | $ | (125,596 | ) | |||
| Net loss per share, basic and diluted | $ | (0.59 | ) | $ | (0.71 | ) | $ | (2.52 | ) | $ | (3.47 | ) | |||
| Weighted average common shares outstanding, basic and diluted | 36,389,492 | 36,229,809 | 36,325,586 | 36,189,002 | |||||||||||
Contact:
Julie Seidel, Stern Investor Relations
(212) 362-1200
investors@bdtx.com
media@bdtx.com