Black Diamond Therapeutics Reports Second Quarter 2024 Financial Results and Provides Corporate Update
06 Agosto 2024 - 6:30AM
Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage
oncology company developing MasterKey therapies that target
families of oncogenic mutations in patients with cancer, today
reported financial results for the second quarter ended
June 30, 2024, and provided a corporate update.
“We continue to execute on enrollment of
patients with EGFR mutant NSCLC into second/third-line and
first-line Phase 2 cohorts, and remain on track to announce initial
results later in the third quarter of this year and in the first
quarter of 2025, respectively”, said Mark Velleca, M.D., Ph.D.,
Chief Executive Officer of Black Diamond Therapeutics. “We also
look forward to sharing analyses of real world data at the 2024
ESMO Congress in September 2024 on treatment practices and
therapeutic outcomes for newly diagnosed NSCLC patients with
non-classical EGFR mutations that demonstrate a significant unmet
medical need.”
Recent Developments & Upcoming
Milestones:
BDTX-1535:
- In April 2024, Black Diamond
described real world evidence of the evolving EGFR mutation
landscape in patients with non-small cell lung cancer (NSCLC) and
the potential of BDTX-1535 to address a broader range of mutations
compared to existing therapies at the 2024 American Association for
Cancer Research (AACR) annual meeting. The analyses revealed a
spectrum of previously underappreciated non-classical mutations, as
well as an increased prevalence of the acquired resistance mutation
C797S. These non-classical EGFR mutations were present in 20-30% of
newly diagnosed epidermal growth factor receptor mutation positive
(EGFRm) NSCLC patients.
- In June 2024, Black Diamond
presented additional data from the Phase 1 dose escalation trial of
BDTX-1535 in patients with relapsed/recurrent glioblastoma (GBM),
and initial intratumoral pharmacokinetic data from a “window of
opportunity” (also known as a Phase 0/1 “Trigger”) trial sponsored
by the Ivy Brain Tumor Center, in patients with recurrent
high-grade glioma (HGG), at the American Society of Clinical
Oncology (ASCO) Annual Meeting. Safety and tolerability data in the
Phase 1 trial were consistent with BDTX-1535 clinical data in
patients with NSCLC previously presented in October 2023 at the
European Organization for Research and Treatment of Cancer-National
Cancer Institute-American Association for Cancer Research
(AACR-NCI-EORTC) International Conference on Molecular Targets and
Cancer Therapeutics. Among 19 efficacy evaluable patients, several
experienced stable disease with promising durability. Results from
the investigator-sponsored trial demonstrated that BDTX-1535
penetrates the blood brain barrier with clinically meaningful
unbound drug concentration in gadolinium non-enhancing regions of
the brain and inhibition of corresponding pharmacodynamic markers.
Eight out of nine patients exceeded the pre-specified threshold for
drug concentration in the brain tumor tissue and continued on
study.
- Black Diamond anticipates the following upcoming key milestones
for BDTX-1535:
- Disclosure of initial Phase 2 data
in 2L/3L EGFRm NSCLC patients with non-classical mutations or the
acquired resistance C797S mutation remains on track for later in Q3
2024.
- Disclosure of initial Phase 2 data
in 1L EGFRm NSCLC patients with non-classical mutations remains on
track for Q1 2025 (NCT05256290).
- An abstract has been accepted for
presentation at the 2024 European Society for Medical Oncology
(ESMO) Congress titled “Real World Evidence of Treatment Practices
and Therapeutic Outcomes for Newly Diagnosed NSCLC Patients with
Non-classical EGFR Mutations Demonstrates High Unmet Medical Need”,
which will detail an analysis of Guardant Inform data on treatment
outcomes for newly diagnosed NSCLC patients with tumors expressing
non-classical mutations.
BDTX-4933:
- BDTX-4933 is a brain-penetrant oral
inhibitor of oncogenic alterations in KRAS, NRAS and BRAF.
- Enrollment of patients with BRAF
and select RAS/MAPK mutation-positive cancers, with an emphasis on
patients with KRAS mutant NSCLC, is progressing through escalating
doses in a Phase 1 trial (NCT05786924). An update from this trial
is on track for Q4 2024.
Corporate
- Chief Business Officer & Chief
Financial Officer, Fang Ni, Pharm.D, will participate in a panel
discussion at the Wedbush PacGrow Healthcare Conference taking
place August 13-14, 2024, in New York, NY.
Financial Highlights
- Cash Position:
Black Diamond ended the second quarter of 2024 with approximately
$123.0 million in cash, cash equivalents, and investments compared
to $131.4 million as of December 31, 2023. Net cash used in
operations was $14.7 million for the second quarter of 2024
compared to $14.4 million for the second quarter of 2023.
- Research and Development
Expenses: Research and development (R&D) expenses were
$12.6 million for the second quarter of 2024, compared to $13.2
million for the same period in 2023. The decrease in R&D
expenses was primarily due to workforce efficiencies and reduced
spending on early discovery projects.
- General and Administrative
Expenses: General and administrative (G&A) expenses
were $9.6 million for the second quarter of 2024, compared to $6.9
million for the same period in 2023. The increase in G&A
expenses was primarily due to an increase in consulting and other
professional fees.
- Net Loss: Net loss
for the second quarter of 2024 was $19.9 million, as compared to
$19.2 million for the same period in 2023.
Financial Guidance
- Black Diamond ended the second
quarter of 2024 with approximately $123.0 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 fourth quarter of 2025.
About Black Diamond
Therapeutics
Black Diamond Therapeutics is a clinical-stage
oncology company developing MasterKey therapies that target
families of oncogenic mutations in patients with cancer. The
Company’s MasterKey therapies are designed to address a broad
spectrum of genetically defined tumors, 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 potential of BDTX-1535 to address the
unmet medical need for newly diagnosed NSCLC patients with
non-classical EGFR mutations and benefit patients with NSCLC across
multiple lines of therapy, 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 relapsed/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, the potential future development plans for BDTX-1535 in NSCLC
and GBM, the estimates regarding the market opportunities for the
Company’s product candidates, and the Company’s expected cash
runway. Any forward-looking statements in this press release 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) |
|
|
June 30, 2024 |
|
December 31, 2023 |
|
(in thousands) |
Cash, cash equivalents, and investments |
$ |
122,971 |
|
|
$ |
131,400 |
|
Total assets |
$ |
149,986 |
|
|
$ |
158,567 |
|
Accumulated deficit |
$ |
(455,565 |
) |
|
$ |
(417,431 |
) |
Total stockholders’ equity |
$ |
111,021 |
|
|
$ |
116,736 |
|
|
|
|
|
|
|
|
|
Black Diamond Therapeutics,
Inc.Consolidated Statements of Operations
(Unaudited)(in thousands, except per share
data) |
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
2024 |
|
2023 |
|
2024 |
|
2023 |
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
$ |
12,556 |
|
|
$ |
13,154 |
|
|
$ |
26,101 |
|
|
$ |
27,907 |
|
General and administrative |
|
9,574 |
|
|
|
6,878 |
|
|
|
16,275 |
|
|
|
13,686 |
|
Total operating expenses |
|
22,130 |
|
|
|
20,032 |
|
|
|
42,376 |
|
|
|
41,593 |
|
Loss from operations |
|
(22,130 |
) |
|
|
(20,032 |
) |
|
|
(42,376 |
) |
|
|
(41,593 |
) |
Other income (expense): |
|
|
|
|
|
|
|
Interest income |
|
464 |
|
|
|
539 |
|
|
|
1,101 |
|
|
|
1,161 |
|
Other income (expense) |
|
1,757 |
|
|
|
341 |
|
|
|
3,141 |
|
|
|
405 |
|
Total other income (expense), net |
|
2,221 |
|
|
|
880 |
|
|
|
4,242 |
|
|
|
1,566 |
|
Net loss |
$ |
(19,909 |
) |
|
$ |
(19,152 |
) |
|
$ |
(38,134 |
) |
|
$ |
(40,027 |
) |
Net loss per share, basic and diluted |
$ |
(0.36 |
) |
|
$ |
(0.52 |
) |
|
$ |
(0.71 |
) |
|
$ |
(1.09 |
) |
Weighted average common shares outstanding, basic and diluted |
|
55,155,220 |
|
|
|
36,516,114 |
|
|
|
53,482,034 |
|
|
|
36,500,085 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contact
For Investors: Mario Corso, Head of Investor
Relations, Black Diamond Therapeutics mcorso@bdtx.com
For Media: media@bdtx.com
Black Diamond Therapeutics (NASDAQ:BDTX)
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