Black Diamond Therapeutics Reports Third Quarter 2023 Financial Results and Provides Corporate Update
November 06 2023 - 6:45AM
Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage
oncology company developing MasterKey therapies that target
families of oncogenic mutations in patients with genetically
defined cancers, today reported financial results for the third
quarter ended September 30, 2023, and provided a corporate update.
“We made significant progress advancing our lead
program BDTX-1535 and presented positive results in patients with
NSCLC from our Phase 1 clinical trial at the AACR-NCI-EORTC Meeting
and are now rapidly enrolling the dose expansion cohorts of the
trial,” said Mark Velleca, M.D., Ph.D., President and Chief
Executive Officer of Black Diamond Therapeutics. “We have a strong
cash position that will allow us to reach numerous important
milestones, including dose expansion data for BDTX-1535 in patients
with NSCLC, dose escalation data for BDTX-1535 in patients with
GBM, and initial Phase 1 data for BDTX-4933 in KRAS, NRAS, and BRAF
mutated cancers with an emphasis on NSCLC.”
Recent Developments & Upcoming
Milestones:
BDTX-1535:
- In September 2023, Black Diamond
announced the dosing of the first patients in the BDTX-1535 Phase 1
clinical trial expansion cohorts. This trial is assessing overall
response rate (ORR) by RECIST 1.1 and durability of response in
patients with non-small cell lung cancer (NSCLC) across two
cohorts: one cohort for patients with the epidermal growth factor
receptor (EGFR) acquired resistance C797S mutation after
progression on a third generation EGFR tyrosine kinase inhibitor
(TKI), and a second cohort for patients with non-classical
(intrinsic) driver mutations after progression on an EGFR TKI
(NCT05256290).
- In October 2023, Black Diamond
presented a poster with new clinical data at the AACR-NCI-EORTC
International Conference on Molecular Targets and Cancer
Therapeutics from the dose escalation portion of the Phase 1
clinical trial of BDTX-1535 in patients with NSCLC. Data shared at
this conference reflect 27 patients with advanced/metastatic NSCLC
who received a range of doses spanning 25mg to 400mg once daily.
These results demonstrated a favorable tolerability profile and
durable responses in patients with NSCLC expressing both acquired
resistance C797S and non-classical driver EGFR mutations.
- Key highlights from the
presentation include:
- Durable clinical responses
at starting dose of 100mg or above in patients with NSCLC who had
multiple lines of prior therapy. Five of the 13 patients
with either non-classical driver, acquired resistance C797S or
complex mutations had a confirmed partial response (PR) by RECIST
1.1. Evidence of reduction in brain metastases was observed,
including a patient with more than three prior therapies. Three
responders continue on therapy for greater than six months (two
confirmed PRs, one unconfirmed PR). One patient with confirmed PR
remained on therapy for six months. Two additional patients with
stable disease continue on therapy for greater than 12 months.
Eradication of targeted variant alleles and significant circulating
tumor DNA (ctDNA) reductions were observed for all NSCLC EGFR
mutation subtypes in patients treated with BDTX-1535 across dose
levels.
- Favorable emerging safety
profile. The majority of adverse events (AEs) at doses of
100mg and 200mg were mild or moderate, and no unexpected safety
signals were identified. No dose limiting toxicities (DLTs) were
observed at 200mg or below.
- In October 2023, enrollment began
in a Phase 0/1 “window of opportunity” clinical trial of BDTX-1535
in patients with recurrent high-grade glioma. The trial is
sponsored by the Ivy Brain Tumor Center in Phoenix, Arizona and is
enrolling patients prior to a planned resection. Patients achieving
adequate drug levels in the gadolinium non-enhancing regions of the
tumor will continue with treatment following surgery.
- Black Diamond anticipates the
following upcoming key milestones for BDTX-1535:
- End-of-Phase 1 Meeting with the
U.S. Food and Drug Administration (FDA) later this year.
- Expansion cohort data in patients
with non-classical driver and acquired resistance EGFR mutant NSCLC
in 2024.
- Phase 1 dose escalation data in
patients with relapsed and recurrent GBM later this year.
- Initial results from an
investigator sponsored “window of opportunity” trial in patients
with GBM in the second quarter of 2024.
BDTX-4933:
- BDTX-4933 is an oral,
brain-penetrant RAF MasterKey inhibitor designed to address
oncogenic alterations in KRAS, NRAS and BRAF, while also avoiding
paradoxical activation.
- 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 (NCT05786924).
- In October 2023, Black Diamond
presented a poster at the AACR-NCI-EORTC International Conference
on Molecular Targets and Cancer Therapeutics detailing preclinical
data for BDTX-4933.
- 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.
BDTX-4933 demonstrated strong anti-tumor activity and regression
across preclinical models expressing several MAPK pathway
mutations, including KRAS G12D, KRAS G12V, and KRAS G13C mutant
NSCLC models. BDTX-4933 exhibited high central nervous system (CNS)
exposure with dose-dependent tumor growth inhibition and survival
benefit in an intracranial xenograft model.
Corporate:
- In September 2023, Black Diamond
announced a CEO transition, appointing Chairman of the Board Mark
Velleca, M.D., Ph.D. to President and Chief Executive Officer.
Financial Highlights
- Cash Position:
Black Diamond ended the third quarter of 2023 with approximately
$144.3 million in cash, cash equivalents, and investments compared
to $122.8 million as of December 31, 2022. Net cash used in
operations was $18.4 million for the third quarter of 2023 compared
to $16.5 million for the third quarter of 2022.
- Research and Development
Expenses: Research and development (R&D) expenses were
$16.2 million for the third quarter of 2023, compared to $15.8
million for the same period in 2022. The increase in R&D
expenses was primarily due to the advancement of the Company’s
pipeline programs, BDTX-1535 and BDTX-4933.
- General and Administrative
Expenses: General and administrative (G&A) expenses
were $7.9 million for the third quarter of 2023, compared to $6.3
million for the same period in 2022. The increase in G&A
expenses was primarily due to costs related to the transition of
its former President and Chief Executive Officer in the third
quarter of 2023, as well as an increase in legal and other
professional fees.
- Net Loss: Net loss
for the third quarter of 2023 was $23.0 million, as compared to
$21.7 million for the same period in 2022.
Financial Guidance
- Black Diamond ended the third
quarter of 2023 with approximately $144.3 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 first half 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 Phase 1 clinical
trial and the expected timing for clinical updates on the dose
expansion cohorts of the BDTX-1535 in patients with NSCLC and on
dose escalation data for BDTX-1535 in patients with recurrent GBM,
the timing of meeting with regulatory agencies 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)
|
September 30,2023 |
|
December 31,2022 |
|
(in thousands) |
Cash, cash equivalents, and investments |
$ |
144,256 |
|
|
$ |
122,807 |
|
Total assets |
$ |
172,382 |
|
|
$ |
156,255 |
|
Accumulated deficit |
$ |
(398,023 |
) |
|
$ |
(334,989 |
) |
Total stockholders’ equity
(deficit) |
$ |
134,317 |
|
|
$ |
115,695 |
|
|
|
|
|
|
|
|
|
Black Diamond Therapeutics,
Inc.
Consolidated Statements of Operations
(Unaudited)
(in thousands, except per share
data)
|
Three Months EndedSeptember 30, |
|
Nine Months Ended September 30, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
$ |
16,154 |
|
|
$ |
15,847 |
|
|
$ |
44,061 |
|
|
$ |
49,828 |
|
General and administrative |
|
7,858 |
|
|
|
6,277 |
|
|
|
21,544 |
|
|
|
21,148 |
|
Total operating expenses |
|
24,012 |
|
|
|
22,124 |
|
|
|
65,605 |
|
|
|
70,976 |
|
Loss from operations |
|
(24,012 |
) |
|
|
(22,124 |
) |
|
|
(65,605 |
) |
|
|
(70,976 |
) |
Other income (expense): |
|
|
|
|
|
|
|
Interest income |
|
439 |
|
|
|
562 |
|
|
|
1,600 |
|
|
|
1,354 |
|
Other income (expense) |
|
566 |
|
|
|
(92 |
) |
|
|
971 |
|
|
|
(469 |
) |
Total other income (expense),
net |
|
1,005 |
|
|
|
470 |
|
|
|
2,571 |
|
|
|
885 |
|
Net loss |
$ |
(23,007 |
) |
|
$ |
(21,654 |
) |
|
$ |
(63,034 |
) |
|
$ |
(70,091 |
) |
Net loss per share, basic and
diluted |
$ |
(0.45 |
) |
|
$ |
(0.60 |
) |
|
$ |
(1.54 |
) |
|
$ |
(1.93 |
) |
Weighted average common shares
outstanding, basic and diluted |
|
50,943,155 |
|
|
|
36,346,181 |
|
|
|
41,367,347 |
|
|
|
36,304,050 |
|
Contact
For Investors:Mario Corso, Head of Investor
Relations, Black Diamond Therapeuticsmcorso@bdtx.com
Julie Seidel, Stern Investor
Relationsinvestors@bdtx.com
For Media:media@bdtx.com
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