Black Diamond Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Corporate Update
March 09 2023 - 6:30AM
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 fourth
quarter and full year ended December 31, 2022, and provided a
corporate update.
“We expect 2023 to be a catalyst rich year for
Black Diamond following tremendous progress for our two novel
MasterKey inhibitors, with BDTX-1535 continuing to advance through
our Phase 1 clinical trial and BDTX-4933 meeting critical
milestones to further progress toward the clinic. The clearance of
the Investigational New Drug (IND) application for BDTX-4933 by the
U.S. Food and Drug Administration (FDA) earlier this year marks our
third IND allowance in three years and demonstrates the strength of
our MAP drug discovery engine along with the expertise of our
research and clinical teams. We are driven by the clear unmet need
for next-generation precision medicines to treat cancers by
overcoming resistance, minimizing on-target and wild-type mediated
toxicities, and addressing brain disease. We’ve designed a robust
pipeline of products with brain penetration properties to address
these key challenges,” said David Epstein, Ph.D., President and
Chief Executive Officer of Black Diamond. “We anticipate a clinical
update for BDTX-1535 in the second half of 2023. We also expect to
initiate the Phase 1 clinical trial of BDTX-4933 in the first half
of this year and to progress our FGFR program and another
undisclosed program toward development candidate nominations in
2023. As we continue to mature our pipeline, we are acutely focused
on delivering meaningful benefit to patients and we believe that
our approach has the potential to strengthen the treatment
landscape for genetically defined cancers.”
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 glioblastoma multiforme
(GBM), as well as in non-small cell lung cancer (NSCLC). BDTX-1535
is fourth generation EGFR inhibitor designed to be irreversible
(covalent) and brain-penetrant, and is unique in that it targets a
family of driver mutations in addition to acquired resistance
mutations arising from the use of third generation EGFR inhibitors
to treat EGFR-positive NSCLC.
- In April 2022, Black Diamond dosed
the first patient in its Phase 1 global clinical trial of BDTX-1535
for the treatment of NSCLC, including in patients with brain
metastases, and GBM. The dose-escalation portion of the Phase 1
clinical trial is actively recruiting and enrolling patients, and
the Company remains on track to provide a clinical update on
BDTX-1535 in the second half of 2023.
- In October 2022, Black Diamond
presented two posters at the 34th European Organisation for
Research and Treatment of Cancer—National Cancer Institute—American
Association for Cancer Research (EORTC-NCI-AACR) Symposium in
Barcelona, Spain, with new preclinical data. The Company detailed
anti-tumor activity of BDTX-1535 in preclinical models and
highlighted that BDTX-1535 is designed using Black Diamond’s
proprietary MAP drug discovery engine to target EGFR mutations of
both NSCLC and GBM. Black Diamond also showcased BDTX-1535’s
ability to achieve potent anti-tumor activity against EGFR
alterations and amplification across preclinical models of NSCLC
classical driver, intrinsic resistance and acquired resistance EGFR
mutations and GBM, including intercranial patient derived xenograft
models.
BDTX-4933:
- BDTX-4933 is designed as a
brain-penetrant, small molecule MasterKey reversible oral inhibitor
of oncogenic BRAF Class I, II and III active RAF dimers promoted by
upstream oncogenic alterations expressed by human cancers, while
also avoiding paradoxical activation.
- In the first quarter of 2023, Black
Diamond received allowance of its IND application from the FDA. The
Company expects to initiate a Phase 1 clinical trial of BDTX-4933
in patients with tumors harboring all-class BRAF or RAS mutations
in the first half of 2023.
- In October 2022, Black Diamond
presented a poster at the 34th EORTC-NCI-AACR Symposium
highlighting preclinical data showing BDTX-4933 to be a
brain-penetrant RAF MasterKey inhibitor active against tumors that
are driven by a Class I, II, or III BRAF mutation, as well as by
other oncogenic RAS pathway alterations that promote constitutive
RAF dimer activation. BDTX-4933 demonstrated potent, on-target
inhibition of the RAF-MEK-ERK signaling pathway and anti-tumor
activity in multiple preclinical models, including intracranial
tumor models.
Discovery-Stage Pipeline and MAP Drug Discovery
Engine:
- Black Diamond continues to leverage
its MAP drug discovery engine to advance its discovery-stage
pipeline to bring therapies to underserved patients. Black Diamond
anticipates progressing its fibroblast growth factor receptor
(FGFR) program towards development candidate nomination and
nomination of a development candidate against an undisclosed target
in 2023.
Corporate:
- In June 2022, Black Diamond
appointed Sergey Yurasov, M.D., Ph.D., as its Chief Medical
Officer, bringing over 25 years of oncology drug development
experience and regulatory expertise.
- In December 2022, Black Diamond
announced that existing board member, Mark Velleca, M.D., Ph.D.,
was appointed to succeed Robert (Bob) A. Ingram as the Chairman of
the Board of Directors.
- In December 2022, Black Diamond
announced the spinout of Launchpad Therapeutics, Inc. (Launchpad),
an antibody-focused precision oncology company incorporating Black
Diamond’s undisclosed early discovery stage antibody programs
enabled by the MAP drug discovery engine. In conjunction with the
transaction, a $30 million Series A financing was co-led by Versant
Ventures and New Enterprise Associates (NEA) to fund discovery and
development activities of the new company. Black Diamond retains a
minority equity interest in Launchpad to enable further value
creation.
Financial Highlights
- Cash Position:
Black Diamond ended 2022 with approximately $122.8 million in cash,
cash equivalents, and investments compared to $209.8 million as of
December 31, 2021. Net cash used in operations was $85.1 million
for the year ended December 31, 2022 compared to $100.1 million for
the year ended December 31, 2021.
- Research and Development
Expenses: Research and development (R&D) expenses were
$14.6 million for the fourth quarter of 2022, compared to $19.7
million for the same period in 2021. Research and development
expenses were $64.4 million for the year ended December 31, 2022,
compared to $96.8 million for the year ended December 31, 2021. 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 upcoming milestones for our
pipeline programs, BDTX-1535 and BDTX-4933.
- General and Administrative
Expenses: General and administrative (G&A) expenses
were $7.2 million for the fourth quarter of 2022, compared to $6.4
million for the same period in 2021, and $28.4 million for the year
ended December 31, 2022, compared to $30.0 million for the year
ended December 31, 2021. 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 2022 was $21.1 million, as compared to
$25.9 million for the same period in 2021. Net loss for the year
ended December 31, 2022 was $91.2 million compared to $125.6
million for the year ended December 31, 2021.
Financial Guidance
- Black Diamond ended 2022 with
approximately $122.8 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
non-small cell lung cancer (NSCLC) and in glioblastoma multiforme
(GBM), and BDTX-4933, a program targeting RAF MasterKey mutations
in solid tumors, as well as discovery-stage research programs. The
Company’s proprietary Mutation-Allostery-Pharmacology, or 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 I clinical trial of BDTX-4933,
the continued development of the FGFR program, including plans for
nominating a development candidate, in addition to plans to
disclose an additional development candidate against a new target,
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)
|
December 31, |
|
|
2022 |
|
|
|
2021 |
|
|
|
|
(in thousands) |
Cash, cash equivalents, and
investments |
$ |
122,807 |
|
|
$ |
209,786 |
|
Total assets |
$ |
156,255 |
|
|
$ |
247,682 |
|
Accumulated deficit |
$ |
(334,989 |
) |
|
$ |
(243,820 |
) |
Total stockholders’ equity
(deficit) |
$ |
115,695 |
|
|
$ |
195,900 |
|
Black Diamond Therapeutics,
Inc.
Consolidated Statements of Operations
(Unaudited)
(in thousands, except per share
data)
|
Three Months EndedDecember 31, |
|
Year EndedDecember 31, |
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
$ |
14,609 |
|
|
$ |
19,664 |
|
|
$ |
64,437 |
|
|
$ |
96,829 |
|
General and administrative |
|
7,243 |
|
|
|
6,416 |
|
|
|
28,391 |
|
|
|
30,043 |
|
Total operating expenses |
|
21,852 |
|
|
|
26,080 |
|
|
|
92,828 |
|
|
|
126,872 |
|
Loss from operations |
|
(21,852 |
) |
|
|
(26,080 |
) |
|
|
(92,828 |
) |
|
|
(126,872 |
) |
Other income (expense): |
|
|
|
|
|
|
|
Interest income |
|
677 |
|
|
|
588 |
|
|
|
2,031 |
|
|
|
3,464 |
|
Other income (expense) |
|
115 |
|
|
|
(375 |
) |
|
|
(354 |
) |
|
|
(2,188 |
) |
Gain on sale of IP |
|
2,232 |
|
|
|
— |
|
|
|
2,232 |
|
|
|
— |
|
Total other income (expense),
net |
|
3,024 |
|
|
|
213 |
|
|
|
3,909 |
|
|
|
1,276 |
|
Equity in (losses) of
unconsolidated entity |
|
(2,250 |
) |
|
|
— |
|
|
|
(2,250 |
) |
|
|
— |
|
Net loss |
$ |
(21,078 |
) |
|
$ |
(25,867 |
) |
|
$ |
(91,169 |
) |
|
$ |
(125,596 |
) |
Net loss per share, basic and
diluted |
$ |
(0.59 |
) |
|
$ |
(0.71 |
) |
|
$ |
(2.52 |
) |
|
$ |
(3.47 |
) |
Weighted average common shares
outstanding, basic and diluted |
|
36,389,492 |
|
|
|
36,229,809 |
|
|
|
36,325,586 |
|
|
|
36,189,002 |
|
Contact: Julie Seidel,
Stern Investor Relations (212)
362-1200 investors@bdtx.com media@bdtx.com
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