- Dosed first patient in Phase 2 trial of BDTX-1535 in 1L patients with non-classical EGFRm NSCLC
- Clinical data on track for Q3 2024 in Phase 2 trial of BDTX-1535 in 2L/3L patients with acquired resistance or non-classical EGFRm NSCLC
- Oral presentation at AACR annual meeting in
April 2024 describing real world evidence of an evolving EGFR mutation landscape in NSCLC, and the potential of BDTX-1535 to benefit patients across multiple lines of therapy - Additional planned data releases for 2024 include GBM results for BDTX-1535 in Q2, and initial results for BDTX-4933 in non-G12C KRASm NSCLC in Q4
- Cash, cash equivalents, and investments of
$131.4 million as ofDecember 31, 2023 , expected to be sufficient to fund operations into the second quarter of 2025
“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
Recent Developments & Upcoming Milestones:
BDTX-1535:
- In
October 2023 , Black Diamond presented a poster with updated clinical data at theEuropean Organization for Research and Treatment ofCancer-National Cancer Institute-American Association for Cancer Research (EORTC-NCI-AACR) Symposium on Molecular Targets and Cancer Therapeutics from the dose escalation portion of the Phase 1 clinical trial of BDTX-1535 in patients with non-small cell lung cancer (NSCLC). The presentation included clinical data from 27 patients with advanced/metastatic NSCLC who received once daily doses ranging from 25mg to 400mg. These results demonstrated a favorable tolerability profile and durable responses in patients with NSCLC expressing both acquired resistance C797S and non-classical driver epidermal growth factor receptor (EGFR) mutations. - Following receipt of End of Phase 1 feedback from the
U.S. Food and Drug Administration (FDA) in the fourth quarter of 2023, Black Diamond initiated a Phase 2 cohort in first-line (1L) patients with non-classical EGFR mutations in early 2024. (NCT05256290) - Phase 0/1 “window of opportunity” clinical trial of BDTX-1535 began enrollment in
October 2023 to evaluate the pharmacokinetic, pharmacodynamic, and clinical response in patients with recurrent high-grade glioma (HGG) with EGFR alterations and/or fusions who are undergoing a planned surgical resection. The trial is sponsored by the Ivy Brain Tumor Center inPhoenix, Arizona . (NCT06072586) - Top-line results disclosed in
December 2023 from the Phase 1 dose escalation trial of BDTX-1535 in patients with relapsed/recurrent glioblastoma (GBM) showed clinical activity in heavily pretreated patients. BDTX-1535 was shown to be generally well tolerated, with no new safety signals observed. - Black Diamond anticipates the following upcoming key milestones for BDTX-1535:
- Oral presentation describing real world data of the evolving EGFR mutation landscape in patients with NSCLC, and the MasterKey profile of BDTX-1535 addressing a broad spectrum of mutations at the
American Association for Cancer Research (AACR) annual meeting onApril 7, 2024 . - Phase 2 clinical data in patients with NSCLC and non-classical driver or acquired resistance EGFR mutations in the third quarter of 2024.
- Phase 1 dose escalation data in patients with relapsed/recurrent GBM, and initial results from the investigator sponsored “window of opportunity” trial in patients with recurrent HGG are expected to be presented at a medical meeting in the second quarter of 2024.
- Oral presentation describing real world data of the evolving EGFR mutation landscape in patients with NSCLC, and the MasterKey profile of BDTX-1535 addressing a broad spectrum of mutations at the
BDTX-4933:
- In
October 2023 , Black Diamond presented a poster at the EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics detailing preclinical data for the clinical-stage MasterKey RAF inhibitor BDTX-4933, a brain-penetrant oral inhibitor of oncogenic alterations in KRAS, NRAS and BRAF. Preclinical results showed that BDTX-4933 potently and selectively inhibited the proliferation of tumor cells expressing a range of KRAS, NRAS and BRAF mutations, suggesting clear differentiation compared to other RAF inhibitors. - A Phase 1 clinical trial for BDTX-4933 was initiated in the second quarter of 2023 in patients with BRAF and select RAS/MAPK mutation-positive cancers, with an emphasis on patients with KRAS mutant NSCLC. The trial is currently in dose escalation with an update anticipated in the fourth quarter of 2024. (NCT05786924)
Financial Highlights
- Cash Position: Black Diamond ended 2023 with approximately
$131.4 million in cash, cash equivalents, and investments compared to$122.8 million as ofDecember 31, 2022 . Net cash used in operations was$66.7 million for the year endedDecember 31, 2023 compared to$85.1 million for the year endedDecember 31, 2022 . - Research and Development Expenses: Research and development (R&D) expenses were
$15.3 million for the fourth quarter of 2023, compared to$14.6 million for the same period in 2022. Research and development expenses were$59.4 million for the year endedDecember 31, 2023 , compared to$64.4 million for the year endedDecember 31, 2022 . The decrease in R&D expenses was primarily due to reduced spending on early discovery projects as we deepen our focus on our clinical-stage assets. - General and Administrative Expenses: General and administrative (G&A) expenses were
$5.6 million for the fourth quarter of 2023, compared to$7.2 million for the same period in 2022, and$27.1 million for the year endedDecember 31, 2023 , compared to$28.4 million for the year endedDecember 31, 2022 . The decrease in G&A expenses was primarily due to a decrease in legal and other professional fees. - Net Loss: Net loss for the fourth quarter of 2023 was
$19.4 million , as compared to$21.1 million for the same period in 2022. Net loss for the year endedDecember 31, 2023 was$82.4 million compared to$91.2 million for the year endedDecember 31, 2022 .
Financial Guidance
- Black Diamond ended 2023 with approximately
$131.4 million in cash, cash equivalents and investments which the Company believes is sufficient to fund its anticipated operating expenses and capital expenditure requirements into the second quarter of 2025.
About
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
Condensed Consolidated Balance Sheet Data (Unaudited) (in thousands) | |||||||
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 | |||
Consolidated Statements of Operations (Unaudited) (in thousands, except per share data) | |||||||||||||||
Three Months Ended | Year Ended | ||||||||||||||
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:
mcorso@bdtx.com
For Media:
media@bdtx.com
Source:
2024 GlobeNewswire, Inc., source