Black Diamond Therapeutics Reports First Quarter 2023 Financial Results and Provides Corporate Update
May 09 2023 - 7:30AM
Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage
precision oncology medicine company developing MasterKey therapies
designed to overcome limitations of existing therapies by targeting
families of oncogenic driver mutations in patients with genetically
defined cancers, today reported financial results for the first
quarter ended March 31, 2023, and provided a corporate update.
“We are incredibly pleased with the pace of
execution since the start of 2023 as we continue to advance our
pipeline programs, BDTX-1535 and BDTX-4933 in addition to our
newest program, BDTX-4876. Having three investigational new drug
(IND) acceptances in three years is exemplary of our breadth of
expertise in precision oncology drug discovery and development. We
are confident that our momentum will continue to bring tremendous
progress across our pipeline as we head further into this
transformational year for Black Diamond,” said David Epstein,
Ph.D., President and Chief Executive Officer of Black Diamond
Therapeutics. “2023 brings several key inflection points, including
a clinical update from the dose-escalation portion of our Phase 1
trial of BDTX-1535 in patients with non-small cell lung cancer
(NSCLC) and glioblastoma multiforme (GBM), the initiation of a
Phase 1 clinical trial for BDTX-4933, and today’s announcement of a
development candidate nomination for our fibroblast growth factor
receptor (FGFR) 2/3 selective program. We remain acutely focused on
bringing our next-generation precision medicines to patients in
need, particularly as we work to expand the addressable patient
population within the broader oncogenic mutation landscape. Our
sophisticated drug design and our deep-rooted commitment to
effectively targeting shared, activated conformations used by
oncogenic drivers for tumor growth are all enabled by our Mutation
Allostery Pharmacology (MAP) drug discovery engine and ultimately
realized by our MasterKey therapies.”
Recent Developments & Upcoming
Milestones:
BDTX-1535:
- BDTX-1535, an epidermal growth
factor receptor (EGFR) MasterKey inhibitor, is being developed to
treat genetically defined cancer in patients whose tumors are
positive for EGFR MasterKey mutations in NSCLC, as well as in GBM.
BDTX-1535 is a fourth generation EGFR inhibitor designed to be
irreversible (covalent) and brain-penetrant and is unique in how it
targets a family of driver and resistance mutations arising from
the use of third generation EGFR inhibitors to treat EGFR-positive
NSCLC.
- In April 2023, Black Diamond
presented two posters highlighting BDTX-1535’s preclinical
development as well as the ongoing Phase 1 clinical trial at the
2023 AACR Annual Meeting. Key highlights from the preclinical
poster included an outline of the unmet need for next generation
EGFR inhibitors that target classical driver mutations as well as
acquired and intrinsic resistance mutations expressed in the
context of EGFR driver mutations in NSCLC, and EGFR alterations
expressed in GBM. Black Diamond also outlined its ongoing Phase 1,
open-label, multicenter clinical trial to assess the safety,
tolerability, pharmacokinetics, central nervous system (CNS)
penetrance and preliminary antitumor activity of BDTX-1535 in
locally advanced or metastatic NSCLC with or without CNS disease or
in recurrent GBM (rGBM).
- Enrollment in the Phase 1 clinical
trial was initiated in 2022 and dose escalation is ongoing. Dose
Expansion cohorts are expected to open in 2023. Black Diamond
remains on track to provide a clinical update on BDTX-1535 in the
second half of 2023.
BDTX-4933:
- BDTX-4933 is designed as a
brain-penetrant, oral MasterKey inhibitor of oncogenic BRAF Class
I, II and III and RAS mutations, while also avoiding paradoxical
activation.
- In the first quarter of 2023, Black
Diamond received allowance of its IND application from the U.S.
Food and Drug Administration (FDA).
- In April 2023, Black Diamond
presented a poster at the 2023 AACR Annual Meeting, outlining its
approach to characterizing RAF, RAS and MAPK pathways in addition
to the design and preclinical development of BDTX-4933. Based on
preclinical data, BDTX-4933 has a potential best-in-class profile
to treat cancer patients harboring oncogenic BRAF Class I, II, III
and RAS mutations, with or without brain disease.
- Black Diamond expects to dose its
first patient in a Phase 1 clinical trial of BDTX-4933 in patients
with tumors harboring all-class BRAF or RAS mutations in the second
quarter of 2023.
Discovery-Stage Pipeline and MAP Drug
Discovery Engine:
- Today, Black Diamond announced that
it selected a development candidate, BDTX-4876, for its FGFR
program. BDTX-4876 is selective against MasterKey mutations and
alterations in FGFR 2 and 3, while sparing FGFR 1 and 4.
- Black Diamond plans to evaluate
strategic alternatives for the FGFR program as it deepens focus on
its two clinical stage assets.
- Black Diamond continues to leverage
its MAP drug discovery engine to advance its discovery-stage
pipeline to bring therapies to underserved patients.
Corporate:
- In March 2023, the Company promoted
Fang Ni, Pharm.D., from interim Chief Financial Officer to
full-time Chief Financial Officer, in addition to his role as Chief
Business Officer.
Financial Highlights
- Cash Position:
Black Diamond ended the first quarter of 2023 with approximately
$103.4 million in cash, cash equivalents, and investments compared
to $122.8 million as of December 31, 2022. Net cash used in
operations was $20.0 million for the first quarter of 2023 compared
to $28.6 million for the first quarter of 2022.
- Research and Development
Expenses: Research and development (R&D) expenses were
$14.8 million for the first quarter of 2023, compared to $17.8
million for the same period in 2022. The decrease in R&D
expenses was primarily due to reduced clinical trial activities
stemming from the discontinuation of the development of BDTX-189 to
focus on advancement of the Company’s pipeline programs, BDTX-1535
and BDTX-4933.
- General and Administrative
Expenses: General and administrative (G&A) expenses
were $6.8 million for the first quarter of 2023, compared to $7.9
million for the same period in 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 first quarter of 2023 was $20.9 million, as compared to
$25.5 million for the same period in 2022.
Financial Guidance
- Black Diamond ended the first
quarter of 2023 with approximately $103.4 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 third quarter of 2024.
About Black Diamond
Therapeutics
Black Diamond Therapeutics is a clinical-stage
precision oncology medicine company focused on the development of
MasterKey therapies that target families of oncogenic mutations in
clinically validated targets. Black Diamond leverages a deep
understanding of cancer genetics and onco-protein structure and
function, to discover and develop innovative MasterKey therapies.
The Company’s MasterKey therapies are designed to overcome
resistance, minimize on-target, wild-type mediated toxicities, and
be brain-penetrant to address significant unmet medical needs of
patients with genetically defined cancers. The Company is advancing
a robust pipeline with lead clinical-stage program BDTX-1535,
targeting MasterKey mutations in both EGFR mutant-positive NSCLC
and in GBM, and BDTX-4933, a program targeting RAF MasterKey
mutations in solid tumors, as well as discovery-stage research
programs. The Company’s proprietary MAP drug discovery engine is
designed to allow Black Diamond to analyze population-level genetic
sequencing tumor data and validate MasterKey mutations. 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 data updates for BDTX-1535 and
the timing for initiating a Phase 1 clinical trial of BDTX-4933,
the continued development of the FGFR program, exploring strategic
alternatives for the FGFR program, the continued development of the
MAP drug discovery engine 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) |
|
|
March 31,2023 |
|
December 31,2022 |
|
(in thousands) |
Cash, cash equivalents, and investments |
$ |
103,366 |
|
|
$ |
122,807 |
|
Total assets |
$ |
135,582 |
|
|
$ |
156,255 |
|
Accumulated deficit |
$ |
(355,864 |
) |
|
$ |
(334,989 |
) |
Total stockholders’ equity (deficit) |
$ |
98,190 |
|
|
$ |
115,695 |
|
|
|
|
|
|
|
|
|
Black Diamond Therapeutics, Inc. |
Consolidated Statements of Operations
(Unaudited) |
(in thousands, except per share data) |
|
|
|
Three Months EndedMarch 31, |
|
|
2023 |
|
|
|
2022 |
|
Operating expenses: |
|
|
|
Research and development |
$ |
14,753 |
|
|
$ |
17,786 |
|
General and administrative |
|
6,808 |
|
|
|
7,893 |
|
Total operating expenses |
|
21,561 |
|
|
|
25,679 |
|
Loss from operations |
|
(21,561 |
) |
|
|
(25,679 |
) |
Other income (expense): |
|
|
|
Interest income |
|
622 |
|
|
|
406 |
|
Other income (expense) |
|
64 |
|
|
|
(234 |
) |
Total other income (expense), net |
|
686 |
|
|
|
172 |
|
Net loss |
$ |
(20,875 |
) |
|
$ |
(25,507 |
) |
Net loss per share, basic and diluted |
$ |
(0.57 |
) |
|
$ |
(0.70 |
) |
Weighted average common shares outstanding, basic and diluted |
|
36,483,878 |
|
|
|
36,271,291 |
|
Contact:Julie Seidel, Stern
Investor Relations(212)
362-1200investors@bdtx.commedia@bdtx.com
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