Black Diamond Therapeutics Reports Second Quarter 2023 Financial Results and Provides Corporate Update
11 August 2023 - 9:30PM
Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage
precision oncology company developing MasterKey therapies that
target families of oncogenic mutations in patients with genetically
defined cancers, today reported financial results for the second
quarter ended June 30, 2023, and provided a corporate update.
“The second quarter of 2023 marked a crucial
period of clinical and operational execution for Black Diamond, and
I am incredibly pleased with our initial dose escalation data
demonstrating a favorable tolerability profile and clinical proof
of activity for BDTX-1535 in NSCLC patients harboring acquired
resistance and intrinsic driver EGFR mutations. With these data in
hand, we believe we are well positioned for rapid advancement of
this novel MasterKey inhibitor for NSCLC patients and are looking
forward to meeting with FDA later this year to discuss our dose
optimization strategy that may enable a potential accelerated
approval pathway as well as the opportunity to study BDTX-1535 in
newly diagnosed NSCLC patients with intrinsic driver mutations,”
said David Epstein, Ph.D., President and Chief Executive Officer of
Black Diamond Therapeutics. “Our recently completed underwritten
public offering provides us with a strong cash position and
extended runway to execute on the robust set of upcoming milestones
for BDTX-1535 and our broader pipeline, all with the goal of
bringing our MasterKey therapies to patients in need.”
Recent Developments & Upcoming
Milestones:
BDTX-1535:
- In June 2023, Black Diamond
announced initial clinical data from the dose escalation portion of
the Phase 1 clinical study of BDTX-1535, an epidermal growth factor
receptor (EGFR) MasterKey inhibitor, demonstrating a favorable
tolerability profile and clinical proof of activity in non-small
cell lung cancer (NSCLC) patients harboring both acquired
resistance and intrinsic driver EGFR mutations. Key highlights from
the readout include:
- Confirmed radiographic partial
response (PR) by RECIST 1.1 achieved across predicted therapeutic
doses in 5 of 12 NSCLC patients in a subgroup, who had measurable
disease at study start, and underwent post baseline tumor
assessment by RECIST 1.1. One additional patient demonstrated
unconfirmed PR, while the remaining six patients had stable
disease.
- Confirmed PRs were observed in
NSCLC patients with a wide range of EGFR mutations including
classical and intrinsic driver mutations and acquired C797S
resistance mutation, as well as complex mutations that include a
combination of classical, intrinsic, and acquired resistance
mutations. Two NSCLC patients demonstrated radiographic improvement
in the peripheral disease and central nervous system (CNS)
metastases.
- BDTX-1535 was generally well
tolerated by NSCLC and glioblastoma multiforme (GBM) patients and
the overall safety profile was consistent with the EGFR tyrosine
kinase inhibitor (TKI) class of drugs. The most common drug-related
adverse events were mild to moderate rash, diarrhea, stomatitis,
paronychia, nausea and fatigue. No patients experienced dose
limiting toxicity at 15-200 mg once-daily (QD) doses. One of 15
patients treated at the 300 mg QD dose experienced dose limiting
diarrhea and 5 of 12 patients at the 400 mg QD dose experienced
dose limiting toxicity (diarrhea, 2 patients; rash, stomatitis,
fatigue and decreased appetite, 1 patient each). No unexpected
safety signal was identified during dose escalation.
- In July 2023, Black Diamond
initiated expansion cohorts to assess overall response rate (ORR)
by RECIST 1.1 in NSCLC patients with EGFR acquired resistance
mutations after progression on a third generation EGFR TKI and
intrinsic driver mutations after progression on an EGFR TKI.
- Black Diamond anticipates the
following key milestones for BDTX-1535:
- Presentation of the full BDTX-1535
dose escalation data in NSCLC at a medical conference in the fourth
quarter of 2023.
- Meeting with the U.S. Food and Drug
Administration (FDA) in the fourth quarter of 2023 to align on
dosing strategy to enable a potential accelerated approval pathway
in NSCLC.
- Initiation of an expansion cohort
in newly diagnosed NSCLC patients with intrinsic driver mutations
after discussion with the FDA.
- Clinical update on BDTX-1535 Phase
1 dose escalation data in recurrent GBM patients in the fourth
quarter 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 April 2023, Black Diamond
presented a poster at the 2023 American Association of Cancer
Research (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 initiated a Phase 1
clinical trial for BDTX-4933 in select indications for patients
harboring all-class BRAF or RAS mutations in the second quarter of
2023.
BDTX-4876:
- BDTX-4876 is a development
candidate FGFR 2/3 MasterKey inhibitor, selective against FGFR 2
and 3 alterations, while sparing FGFR 1 and 4.
- Black Diamond is evaluating
strategic alternatives for BDTX-4876 as it deepens focus on its two
clinical-stage assets.
Discovery-Stage Pipeline and MAP Drug Discovery
Engine:
- Black Diamond continues to leverage
its Mutation-Allostery-Pharmacology (MAP) drug discovery engine to
advance its discovery-stage pipeline to bring therapies to
underserved patients and expects to progress another undisclosed
program in solid tumors to development candidate nomination in
2023.
Corporate:
- In June 2023, Black Diamond
announced the promotion of Melanie Morrison to Chief Development
Officer.
- In July 2023, Black Diamond closed
an underwritten public offering (Follow-on Offering) of 15,000,000
shares of its common stock at a public offering price of $5.00 per
share for gross proceeds of approximately $75.0 million, before
deducting underwriting discounts and commissions and other offering
expenses.
Financial Highlights
- Cash Position:
Black Diamond ended the second quarter of 2023 with approximately
$89.5 million in cash, cash equivalents, and investments compared
to $122.8 million as of December 31, 2022. Net cash used in
operations was $14.4 million for the second quarter of 2023
compared to $18.1 million for the second quarter of 2022.
- Research and Development
Expenses: Research and development (R&D) expenses were
$13.2 million for the second quarter of 2023, compared to $16.2
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 $6.9 million for the second quarter of 2023, compared to $7.0
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 second quarter of 2023 was $20.0 million, as compared to
$23.2 million for the same period in 2022.
Financial Guidance
- Black Diamond ended the second
quarter of 2023 with approximately $89.5 million in cash, cash
equivalents and investments. The Company believes that the net
proceeds from the Follow-on Offering, together with its existing
cash, cash equivalents and investments, will enable the Company to
fund its operating expenses and capital expenditure requirements
into the first half of 2025.
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 a potential accelerated approval
pathway for BDTX-1535 in NSCLC and the upcoming clinical update on
BDTX-1535 in recurrent GBM patients, exploring strategic
alternatives for BDTX-4876, 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)
|
June 30,2023 |
|
December 31,2022 |
|
(in thousands) |
Cash, cash equivalents, and
investments |
$ |
89,527 |
|
|
$ |
122,807 |
|
Total assets |
$ |
119,879 |
|
|
$ |
156,255 |
|
Accumulated deficit |
$ |
(375,016 |
) |
|
$ |
(334,989 |
) |
Total stockholders’ equity
(deficit) |
$ |
82,199 |
|
|
$ |
115,695 |
|
Black Diamond Therapeutics,
Inc.
Consolidated Statements of Operations
(Unaudited)
(in thousands, except per share
data)
|
Three Months EndedJune 30, |
|
Six Months Ended June 30, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
$ |
13,154 |
|
|
$ |
16,195 |
|
|
$ |
27,907 |
|
|
$ |
33,981 |
|
General and administrative |
|
6,878 |
|
|
|
6,978 |
|
|
|
13,686 |
|
|
|
14,871 |
|
Total operating expenses |
|
20,032 |
|
|
|
23,173 |
|
|
|
41,593 |
|
|
|
48,852 |
|
Loss from operations |
|
(20,032 |
) |
|
|
(23,173 |
) |
|
|
(41,593 |
) |
|
|
(48,852 |
) |
Other income (expense): |
|
|
|
|
|
|
|
Interest income |
|
539 |
|
|
|
386 |
|
|
|
1,161 |
|
|
|
792 |
|
Other income (expense) |
|
341 |
|
|
|
(143 |
) |
|
|
405 |
|
|
|
(377 |
) |
Total other income (expense),
net |
|
880 |
|
|
|
243 |
|
|
|
1,566 |
|
|
|
415 |
|
Net loss |
$ |
(19,152 |
) |
|
$ |
(22,930 |
) |
|
$ |
(40,027 |
) |
|
$ |
(48,437 |
) |
Net loss per share, basic and
diluted |
$ |
(0.52 |
) |
|
$ |
(0.63 |
) |
|
$ |
(1.09 |
) |
|
$ |
(1.33 |
) |
Weighted average common shares
outstanding, basic and diluted |
|
36,516,114 |
|
|
|
36,293,856 |
|
|
|
36,500,085 |
|
|
|
36,282,636 |
|
Contact
Julie Seidel, Stern Investor Relations
(212) 362-1200
investors@bdtx.com
media@bdtx.com
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