Black Diamond Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Update
2024年3月12日 - 9:00PM
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:
- In October 2023, Black Diamond
presented a poster with updated clinical data at the European
Organization for Research and Treatment of Cancer-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 in Phoenix, 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 on April 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.
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 of
December 31, 2022. Net cash used in operations was $66.7 million
for the year ended December 31, 2023 compared to $85.1 million for
the year ended December 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 ended December 31, 2023,
compared to $64.4 million for the year ended December 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
ended December 31, 2023, compared to $28.4 million for the year
ended December 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
ended December 31, 2023 was $82.4 million compared to $91.2 million
for the year ended December 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 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) |
|
|
Three Months EndedDecember 31, |
|
Year Ended December 31, |
|
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 Therapeuticsmcorso@bdtx.com
For Media:media@bdtx.com
Black Diamond Therapeutics (NASDAQ:BDTX)
過去 株価チャート
から 4 2024 まで 5 2024
Black Diamond Therapeutics (NASDAQ:BDTX)
過去 株価チャート
から 5 2023 まで 5 2024