Entrada Therapeutics, Inc. (Nasdaq: TRDA) is a clinical-stage
biopharmaceutical company aiming to transform the lives of patients
by establishing a new class of medicines that engage intracellular
targets that have long been considered inaccessible. The Company
today reported financial results for the first quarter ended March
31, 2024, and highlighted recent business updates.
“The first quarter of 2024 was a period of
significant clinical progress for Entrada. We initiated dosing for
the fourth and final cohort of our Phase 1 clinical trial of
ENTR-601-44 for DMD and our partner Vertex announced that
enrollment and dosing are underway in their global Phase 1/2
clinical trial of VX-670 for DM1,” said Dipal Doshi, Chief
Executive Officer of Entrada Therapeutics. “With two neuromuscular
programs from Entrada's development pipeline now in the clinic and
a cash runway expected through the second quarter of 2026, we
believe we are well positioned to execute on several important
clinical milestones across our pipeline of intracellular
therapeutic candidates in 2024 and beyond.”
Recent Corporate Highlights
- The Company completed dosing for the first three cohorts and
has initiated dosing for the fourth and final cohort of its Phase 1
clinical trial, ENTR-601-44-101, for the potential treatment of
individuals with Duchenne muscular dystrophy (DMD) who are exon 44
skipping amenable. Entrada expects to report data from the clinical
trial in October of 2024.
- The Company is on track to submit regulatory applications in
the fourth quarter of 2024 to initiate independent global Phase 2
clinical development studies for ENTR-601-44 in patients with DMD
who are exon 44 skipping amenable and ENTR-601-45 in patients with
DMD who are exon 45 skipping amenable.
- Vertex announced that its U.S. Investigational New Drug
Application (IND) for the Phase 1/2 clinical trial of VX-670 in
people with myotonic dystrophy type 1 (DM1) has cleared, as have
the Clinical Trial Applications (CTAs) in Canada, the U.K. and the
EU, and the Clinical Trials Notification (CTN) in Australia. Vertex
further noted that enrollment and dosing are underway.
- In March 2024, Entrada achieved a milestone under its global
collaboration with Vertex related to the clinical advancement of
Vertex’s Phase 1/2 clinical trial of VX-670, which triggered a $75
million payment. The Company expects to receive this payment in the
second quarter of 2024. The Company is eligible to receive up to
$485 million, inclusive of milestones achieved to date, for the
successful achievement of certain research, development, regulatory
and commercial milestones, and tiered royalties on future net sales
for any products that may result from this collaboration
agreement.
First Quarter 2024 Financial
Results
Cash Position: Cash, cash
equivalents and marketable securities were $327.4 million as of
March 31, 2024, compared to $352.0 million as of December 31, 2023.
Entrada anticipates that its cash, cash equivalents and marketable
securities as of March 31, 2024, together with ongoing
research support from Vertex and the clinical advancement milestone
expected to be received in the second quarter of 2024, will be
sufficient to extend its cash runway through the second quarter of
2026, supporting the Company's expansion and continued development
of EEV therapeutic candidates targeting DMD and advance
EEV-therapeutic candidates in indications beyond neuromuscular
disease.
Collaboration Revenue:
Collaboration revenue was $59.1 million for the first quarter of
2024, compared to $25.3 million for the same period in 2023. The
increase was primarily a result of the clinical advancement
milestone achieved in the first quarter of 2024.
Research & Development (R&D)
Expenses: R&D expenses were $28.6 million for the
first quarter of 2024, compared to $23.1 million for the same
period in 2023. The increase was primarily due to the progression
of the Company’s ENTR-601-44 Phase 1 clinical trial, costs incurred
for IND-enabling studies for ENTR-601-45 and ENTR-601-50 to support
future clinical trials, additional platform investment, and higher
personnel costs (including non-cash, stock-based compensation).
General & Administrative (G&A)
Expenses: G&A expenses were $9.4 million for the first
quarter of 2024, compared to $7.9 million for the same period in
2023. The increase was primarily due to higher personnel costs
(including non-cash, stock-based compensation).
Net Income (Loss): Net income was
$23.5 million for the first quarter of 2024, compared to a net loss
of $(6.7) million for the same period in 2023.
About Entrada Therapeutics
Entrada Therapeutics is a clinical-stage biopharmaceutical company
aiming to transform the lives of patients by establishing a new
class of medicines that engage intracellular targets that have long
been considered inaccessible. The Company’s Endosomal Escape
Vehicle (EEV™)-therapeutics are designed to enable the efficient
intracellular delivery of a wide range of therapeutics into a
variety of organs and tissues, resulting in an improved therapeutic
index. Through this proprietary, versatile and modular approach,
Entrada is advancing a robust development portfolio of RNA-,
antibody- and enzyme-based programs for the potential treatment of
neuromuscular, ocular, metabolic and immunological diseases, among
others. The Company’s lead oligonucleotide programs are in
development for the potential treatment of people living with
Duchenne who are exon 44, 45 and 50 skipping amenable. Entrada has
partnered to develop a clinical-stage program, VX-670, for myotonic
dystrophy type 1.
For more information about Entrada, please visit
our website, www.entradatx.com, and follow us on LinkedIn.
Forward-Looking Statements This
press release contains forward-looking statements that involve
substantial risks and uncertainties. All statements, other than
statements of historical facts, contained in this press release,
including statements regarding Entrada’s strategy, future
operations, prospects and plans, objectives of management,
Entrada’s ability to continue to recruit for and complete its
ongoing healthy volunteer trial for ENTR-601-44 in the UK with
dosing complete through the third cohort, the ability of Entrada’s
partner Vertex to recruit for and complete its Phase 1/2 clinical
trial in patients with DM1 in Canada and to initiate a Phase 1/2
clinical trial in patients with DM1 in the US, the UK, the EU and
Australia, expectations regarding the timing of data from its Phase
1 clinical trial for ENTR-601-44 in October of 2024, expectations
regarding the submission of regulatory applications in the fourth
quarter of 2024 for ENTR-601-44 in patients with DMD who are exon
44 skipping amenable and ENTR-601-45 in patients with DMD who are
exon 45 skipping amenable, expectations regarding the therapeutic
benefits of ENTR-601-44, the continued development and advancement
of ENTR-601-44, ENTR-601-45 and ENTR-601-50 for the treatment of
DMD and our partnered candidate VX-670 for the treatment of DM1,
expectations regarding the expected timing, progress and success of
our collaboration with Vertex, including the receipt of the $75
million milestone payment from Vertex and any future payments we
may receive under our collaboration and license agreements, the
ability to develop additional therapeutic programs, including
further exon skipping programs, the potential therapeutic benefits
of its EEV candidates, express and implied statements regarding any
future payments Entrada may receive under the Vertex Agreement, and
the sufficiency of its cash resources through the second quarter of
2026, constitute forward-looking statements within the meaning of
The Private Securities Litigation Reform Act of 1995. The words
“anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,”
“intend,” “may,” “might,” “objective,” “ongoing,” “plan,”
“predict,” “project,” “potential,” “should,” or “would,” or the
negative of these terms, or other comparable terminology are
intended to identify forward-looking statements, although not all
forward-looking statements contain these identifying words. Entrada
may not actually achieve the plans, intentions or expectations
disclosed in these forward-looking statements, and you should not
place undue reliance on these forward-looking statements. Actual
results or events could differ materially from the plans,
intentions and expectations disclosed in these forward-looking
statements as a result of various important factors, including:
uncertainties inherent in the identification and development of
product candidates, including the conduct of research activities
and the initiation and completion of preclinical studies and
clinical trials; uncertainties as to the availability and timing of
results from preclinical studies and clinical trials; the timing of
and Entrada’s ability to submit and obtain regulatory clearance for
IND or equivalent foreign applications and initiate or complete
clinical trials; whether results from preclinical studies will be
predictive of the results of later preclinical studies and clinical
trials; whether Entrada’s cash resources will be sufficient to fund
the Company’s foreseeable and unforeseeable operating expenses and
capital expenditure requirements; as well as the risks and
uncertainties identified in Entrada’s filings with the Securities
and Exchange Commission (SEC), including the Company’s most recent
Form 10-K and in subsequent filings Entrada may make with the SEC.
In addition, the forward-looking statements included in this press
release represent Entrada’s views as of the date of this press
release. Entrada anticipates that subsequent events and
developments will cause its views to change. However, while Entrada
may elect to update these forward-looking statements at some point
in the future, it specifically disclaims any obligation to do so.
These forward-looking statements should not be relied upon as
representing Entrada’s views as of any date subsequent to the date
of this press release.
ENTRADA
THERAPEUTICS, INC.Condensed Consolidated
Statements of Operations (Unaudited)(In thousands,
except share and per share amounts) |
|
|
Three Months
Ended March 31, |
|
|
2024 |
|
|
|
2023 |
|
Collaboration revenue |
$ |
59,120 |
|
|
$ |
25,260 |
|
Operating
expenses: |
|
|
|
Research and development |
|
28,608 |
|
|
|
23,102 |
|
General and administrative |
|
9,399 |
|
|
|
7,938 |
|
Total operating expenses |
|
38,007 |
|
|
|
31,040 |
|
Income
(loss) from operations |
|
21,113 |
|
|
|
(5,780 |
) |
Other
income: |
|
|
|
Interest and other income |
|
4,214 |
|
|
|
2,657 |
|
Total other income |
|
4,214 |
|
|
|
2,657 |
|
Income
(loss) before provision for income taxes |
|
25,327 |
|
|
|
(3,123 |
) |
Provision for income taxes |
|
(1,831 |
) |
|
|
(3,551 |
) |
Net income
(loss) |
$ |
23,496 |
|
|
$ |
(6,674 |
) |
Net income
(loss) per share, basic |
$ |
0.70 |
|
|
$ |
(0.21 |
) |
Net income
(loss) per share, diluted |
$ |
0.68 |
|
|
$ |
(0.21 |
) |
ENTRADA
THERAPEUTICS, INC.Condensed Consolidated
Balance Sheet Data (Unaudited)(In
thousands) |
|
|
March
31,2024 |
|
December
31,2023 |
|
|
Cash, cash equivalents and marketable securities |
$ |
327,414 |
|
|
$ |
351,969 |
|
Total
assets |
|
510,844 |
|
|
|
469,192 |
|
Total
liabilities |
|
241,477 |
|
|
|
226,832 |
|
Total
stockholders’ deficit |
|
269,367 |
|
|
|
242,360 |
|
|
|
|
|
|
|
|
|
Investor and Media Contact Karla
MacDonald Chief Corporate Affairs Officer
kmacdonald@entradatx.com
Entrada Therapeutics (NASDAQ:TRDA)
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