CAMBRIDGE, Mass., March 12, 2024 (GLOBE NEWSWIRE) — Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage oncology company focused on the development of MasterKey therapies to treat patients with genetically defined tumors, today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided a corporate update.
“The year 2023 was exciting, with generation of clinical data that positions BDTX-1535 as a potential first and best in class 4th generation EGFR TKI, and we recently began dosing first-line patients in a Phase 2 trial in NSCLC with non-classical mutations,” said Mark Velleca, M.D., Ph.D., President and Chief Executive Officer of Black Diamond Therapeutics. “This year will be data rich across our pipeline, with Phase 2 data for BDTX-1535 in NSCLC, additional GBM results, and initial Phase 1 data for BDTX-4933 in non-G12C KRAS mutated NSCLC.”
Recent Developments & Upcoming Milestones:
BDTX-1535:
BDTX-4933:
Financial Highlights
Financial Guidance
About Black Diamond Therapeutics
Black Diamond Therapeutics is a clinical-stage oncology company focused on the development of MasterKey therapies that address families of oncogenic mutations in clinically validated targets. The Company’s MasterKey therapies are designed to address broad genetically defined patient populations, overcome resistance, minimize wild-type mediated toxicities, and be brain penetrant to treat CNS disease. The Company is advancing two clinical-stage programs: BDTX-1535, a brain-penetrant fourth-generation EGFR MasterKey inhibitor targeting EGFR mutant NSCLC and GBM, and BDTX-4933, a brain-penetrant RAF MasterKey inhibitor targeting KRAS, NRAS and BRAF alterations in solid tumors. 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 clinical trials and the timing of clinical updates for BDTX-1535 in patients with NSCLC and in patients with recurrent GBM, and for Phase 1 clinical trial results for BDTX-4933, the expected timing for additional updates on data from the “window of opportunity” clinical trial of BDTX-1535 in patients with recurrent HGG, potential future development plans for BDTX-1535 in NSCLC and GBM, including in first-line settings, 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, 2023, 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, | |||||||
2023 | 2022 | ||||||
(in thousands) | |||||||
Cash, cash equivalents, and investments | $ | 131,400 | $ | 122,807 | |||
Total assets | $ | 158,567 | $ | 156,255 | |||
Accumulated deficit | $ | (417,431 | ) | $ | (334,989 | ) | |
Total stockholders’ equity | $ | 116,736 | $ | 115,695 | |||
Black Diamond Therapeutics, Inc.
Consolidated Statements of Operations (Unaudited) (in thousands, except per share data) |
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Three Months Ended December 31, |
Year Ended December 31, |
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2023 | 2022 | 2023 | 2022 | ||||||||||||
Operating expenses: | |||||||||||||||
Research and development | $ | 15,289 | $ | 14,609 | $ | 59,350 | $ | 64,437 | |||||||
General and administrative | 5,566 | 7,243 | 27,110 | 28,391 | |||||||||||
Total operating expenses | 20,855 | 21,852 | 86,460 | 92,828 | |||||||||||
Loss from operations | (20,855 | ) | (21,852 | ) | (86,460 | ) | (92,828 | ) | |||||||
Other income (expense): | |||||||||||||||
Interest income | 324 | 677 | 1,924 | 2,031 | |||||||||||
Other income (expense) | 1,123 | 115 | 2,094 | (354 | ) | ||||||||||
Gain on sale of IP | — | 2,232 | — | 2,232 | |||||||||||
Total other income (expense), net | 1,447 | 3,024 | 4,018 | 3,909 | |||||||||||
Equity in (losses) of unconsolidated entity | — | (2,250 | ) | — | (2,250 | ) | |||||||||
Net loss | $ | (19,408 | ) | $ | (21,078 | ) | $ | (82,442 | ) | $ | (91,169 | ) | |||
Net loss per share, basic and diluted | $ | (0.34 | ) | $ | (0.59 | ) | $ | (1.88 | ) | $ | (2.52 | ) | |||
Weighted average common shares outstanding, basic and diluted | 51,637,433 | 36,389,492 | 43,954,649 | 36,325,586 | |||||||||||
Contact
For Investors:
Mario Corso, Head of Investor Relations, Black Diamond Therapeutics
mcorso@bdtx.com
For Media:
media@bdtx.com
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