Entrada Therapeutics, Inc. (Nasdaq: TRDA), a biopharmaceutical
company aiming to transform the lives of patients by establishing
intracellular Endosomal Escape Vehicle (EEV™)-therapeutics as a new
class of medicines, today reported financial results for the second
quarter ending June 30, 2023, and highlighted recent business
updates.
"We are excited to transition into a clinical
stage company with the initiation of our planned Phase 1 trial for
our lead Duchenne product candidate, ENTR-601-44. There is a
profound need for people living with Duchenne who are exon 44
skipping amenable and we look forward to dosing the first
participant in the United Kingdom this September,” said Dipal
Doshi, President and Chief Executive Officer of Entrada
Therapeutics. “Our fundamentals are strong and with the extension
of our cash runway through the end of 2025, we believe we are
well-positioned to advance our Duchenne franchise and introduce new
indications outside of neuromuscular diseases, creating value for
patients and shareholders alike.”
Recent Corporate Highlights
Entrada received authorization from the United
Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA)
and Research Ethics Committee (REC) for its Clinical Trial of an
Investigational Medicinal Product (CTIMP) for a Phase 1 clinical
trial in healthy volunteers for ENTR-601-44, the Company’s lead
product candidate within its Duchenne franchise. This trial is an
important part of the overall global clinical development of
ENTR-601-44 and the Company believes it will provide clinical data
to support the program’s next steps, which include a global
multiple ascending dose trial in patients with Duchenne who are
exon 44 skipping amenable.
The Phase 1 clinical trial’s primary objective is
to evaluate the safety of a single dose of ENTR-601-44 in healthy
volunteers, with a target enrollment of approximately 40
participants. It will also evaluate tolerability, pharmacokinetics
and target engagement as measured by exon skipping in the skeletal
muscle. The first participant is expected to be dosed in September
of this year with data anticipated in the second half of 2024.
In parallel, Entrada is committed to resolving the
clinical hold on its Investigational New Drug (IND) application for
ENTR-601-44 with the U.S. Food and Drug Administration (FDA) and
expects to provide an update in the fourth quarter of 2023.
Upcoming Conferences
The Company will present at the following investor
conferences during the third quarter of 2023:
- Wells Fargo 2023 Healthcare Conference in Boston, MA on
September 6-8, 2023
- H.C. Wainwright 25th Annual Global Investment Conference in New
York, NY on September 11-13, 2023
Second Quarter 2023 Financial
Results
Cash Position: Cash, cash
equivalents and marketable securities were $376.8 million as of
June 30, 2023, compared to $188.7 million as of December 31, 2022.
Entrada anticipates that its cash, cash equivalents and marketable
securities as of June 30, 2023, together with ongoing research
support and the anticipated achievement of certain milestones under
the Vertex Agreement, will be sufficient to extend its cash runway
through 2025.
Collaboration Revenue:
Collaboration revenue was $18.2 million for the second quarter of
2023. There was no collaboration revenue in the second quarter of
2022.
Research & Development (R&D)
Expenses: R&D expenses were $26.3 million for the
second quarter of 2023, compared to $16.2 million for the same
period in 2022. This increase was primarily due to additional
investment in IND-enabling studies to support future clinical
trials, sublicense fees and higher personnel costs, including
non-cash, stock-based compensation.
General & Administrative (G&A)
Expenses: G&A expenses were $8.2 million for the
second quarter of 2023, compared to $7.3 million for the same
period in 2022. This increase was primarily due to higher personnel
costs, including non-cash, stock-based compensation, legal costs
and other costs to support its continued research and development
activities.
Net Loss: Net loss was $25.9
million for the second quarter of 2023, compared to a net loss of
$23.2 million for the same period in 2022.
About Entrada Therapeutics
Entrada Therapeutics is a biopharmaceutical company aiming to
transform the lives of patients by establishing a new class of
medicines, Endosomal Escape Vehicle (EEV™)-therapeutics, to engage
intracellular targets that have long been considered inaccessible
and undruggable. The Company’s 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 its proprietary, highly
versatile and modular EEV platform, Entrada is building a robust
development portfolio of RNA-, antibody- and enzyme-based programs
for the potential treatment of neuromuscular, immunological, ocular
and metabolic diseases, among others. The Company’s lead
oligonucleotide programs include ENTR-601-44 and ENTR-601-45 for
the potential treatment of people living with Duchenne who are exon
44 and 45 skipping amenable, respectively, as well as our partnered
candidate ENTR-701 targeting myotonic dystrophy type 1 (DM1).
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 initiate and recruit for its planned healthy
volunteer trial for ENTR-601-44 in the United Kingdom with the
first participant dosed in September 2023, express or implied
statements regarding the clinical hold on the IND for ENTR-601-44,
Entrada’s ability to address the FDA’s concerns regarding its IND
for ENTR-601-44, expectations regarding the timing and content of
any update expected in the fourth quarter of 2023 concerning the
clinical hold on the IND for ENTR-601-44, expectations regarding
the timing of data from its Phase 1 clinical trial for ENTR-601-44
in the second half of 2024, expectations regarding the therapeutic
benefits of ENTR-601-44, the continued development and advancement
of ENTR-601-44 and ENTR-601-45 for the treatment of Duchenne and
ENTR-701 for the treatment of DM1, including the IND
application-enabling studies, the ability to develop additional
therapeutic programs, including further exon skipping programs, the
potential therapeutic benefits of its EEV candidates, and the
sufficiency of its cash resources through 2025, 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 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 June 30, |
|
Six Months Ended June 30, |
|
2023 |
|
2022 |
|
2023 |
|
2022 |
Collaboration revenue |
$ |
18,170 |
|
|
$ |
— |
|
|
$ |
43,430 |
|
|
$ |
— |
|
Operating
expenses: |
|
|
|
|
|
|
|
Research and development |
|
26,300 |
|
|
|
16,248 |
|
|
|
49,402 |
|
|
|
31,966 |
|
General and administrative |
|
8,169 |
|
|
|
7,334 |
|
|
|
16,107 |
|
|
|
13,767 |
|
Total operating expenses |
|
34,469 |
|
|
|
23,582 |
|
|
|
65,509 |
|
|
|
45,733 |
|
Loss from
operations |
|
(16,299 |
) |
|
|
(23,582 |
) |
|
|
(22,079 |
) |
|
|
(45,733 |
) |
Other
income: |
|
|
|
|
|
|
|
Interest and other income |
|
4,218 |
|
|
|
403 |
|
|
|
6,875 |
|
|
|
883 |
|
Total other income |
|
4,218 |
|
|
|
403 |
|
|
|
6,875 |
|
|
|
883 |
|
Loss before
provision for income taxes |
|
(12,081 |
) |
|
|
(23,179 |
) |
|
|
(15,204 |
) |
|
|
(44,850 |
) |
Provision for income taxes |
|
(13,847 |
) |
|
|
— |
|
|
|
(17,398 |
) |
|
|
— |
|
Net
loss |
$ |
(25,928 |
) |
|
$ |
(23,179 |
) |
|
$ |
(32,602 |
) |
|
$ |
(44,850 |
) |
Net loss per
share attributable to common stockholders, basic and diluted |
$ |
(0.78 |
) |
|
$ |
(0.74 |
) |
|
$ |
(0.99 |
) |
|
$ |
(1.43 |
) |
Weighted‑average common shares outstanding, basic and diluted |
|
33,163,320 |
|
|
|
31,275,306 |
|
|
|
32,770,989 |
|
|
|
31,261,189 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ENTRADA
THERAPEUTICS, INC.Condensed Consolidated
Balance Sheet Data (Unaudited)(In
thousands) |
|
|
|
|
|
June 30,2023 |
|
December 31,2022 |
Cash, cash equivalents and marketable securities |
$ |
376,789 |
|
|
$ |
188,712 |
|
Total
assets |
|
493,983 |
|
|
|
252,056 |
|
Total
liabilities |
|
287,075 |
|
|
|
39,502 |
|
Total
stockholders’ deficit |
|
206,908 |
|
|
|
212,554 |
|
|
|
|
|
|
|
|
|
Investor and Media Contact Karla
MacDonald Chief Corporate Affairs Officer
kmacdonald@entradatx.com
Entrada Therapeutics (NASDAQ:TRDA)
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