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 third
quarter ending September 30, 2023, and highlighted recent business
updates.
“The third quarter marked an important milestone for Entrada, as
we transitioned into a clinical-stage company, with the initiation
of the Phase 1 clinical trial in healthy volunteers for our lead
Duchenne product candidate, ENTR-601-44. Duchenne muscular
dystrophy is a relentlessly progressive neurodegenerative disease,
and we are committed to bringing forward potential new therapeutic
options for people living with Duchenne who have mutations that are
amenable to particular exon skipping therapies,” said Dipal Doshi,
President and Chief Executive Officer of Entrada Therapeutics. “We
are well-positioned to embark upon our next phase of growth, as we
further advance our Duchenne franchise and progress indications
beyond neuromuscular diseases.”
Recent Corporate Highlights
- In September 2023, Entrada dosed the first participant in its
Phase 1 clinical trial evaluating ENTR-601-44 for the potential
treatment of individuals with Duchenne muscular dystrophy (DMD) who
are exon 44 skipping amenable. The primary objective of Entrada’s
Phase 1 clinical trial, which is being conducted in the United
Kingdom, is to evaluate the safety and tolerability of a single
dose of ENTR-601-44 in healthy male volunteers, with a target
enrollment of approximately 40 participants. The trial will also
evaluate pharmacokinetics and target engagement, as measured by
exon skipping in skeletal muscle. Entrada expects to report data
from the Phase 1 clinical trial in the second half of 2024.The
Company will provide an update on the clinical hold on its
Investigational New Drug (IND) application for ENTR-601-44 with the
U.S. Food and Drug Administration (FDA) in the fourth quarter of
2023.
- Entrada announced the selection of a third clinical candidate
within its Duchenne franchise, ENTR-601-50, for the potential
treatment of people living with Duchenne who are exon 50 skipping
amenable. The selection of ENTR-601-50 is based on in vivo
preclinical data demonstrating robust exon 50 skipping and
dystrophin production across cardiac and skeletal muscle groups.
Entrada expects to present these preclinical data in the first half
of 2024 and plans to submit a Clinical Trial Application
(CTA)/IND submission to initiate clinical development for
ENTR-601-50 in 2025.
- In October 2023, the Company achieved a milestone pursuant to
the Vertex Agreement related to preclinical IND-enabling GLP
toxicology studies of ENTR-701 that triggered a $17.5 million
milestone payment, which the Company expects to receive in the
fourth quarter of 2023.
- In July 2023, Entrada entered into a license agreement to
advance the development of ENTR-501 with Pierrepont Therapeutics,
Inc., a mitochondrial disease-focused company. ENTR-501 is an
intracellular thymidine phosphorylase enzyme replacement therapy in
development for the treatment of mitochondrial
neurogastrointestinal encephalomyopathy (MNGIE). MNGIE is a slowly
progressive and fatal, ultra rare disease for which there are no
treatment options available.
Third Quarter 2023 Financial Results
Cash Position: Cash, cash equivalents and
marketable securities were $353.6 million as of September 30, 2023,
compared to $188.7 million as of December 31, 2022. Entrada
anticipates that its cash, cash equivalents and marketable
securities as of September 30, 2023, together with Vertex
collaboration ongoing research support and the anticipated
achievement of certain milestones, will be sufficient to fund the
Company's operating expenses and capital expenditure requirements
through 2025.
Collaboration Revenue: Collaboration revenue
was $43.7 million for the third quarter of 2023. There was no
collaboration revenue in the third quarter of 2022.
Research & Development (R&D) Expenses:
R&D expenses were $22.2 million for the third quarter of 2023,
compared to $19.0 million for the same period in 2022. This
increase was primarily due to the initiation of the ENTR-601-44
Phase 1 clinical trial, additional investment in IND-enabling
studies to support future clinical trials and higher personnel
costs, including non-cash, stock-based compensation.
General & Administrative (G&A)
Expenses: G&A expenses were $7.5 million for the third
quarter of 2023, compared to $7.0 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 ongoing clinical trial and continued research
and development activities.
Net Income (Loss): Net income was $35.5 million
for the third quarter of 2023, compared to a net loss of $(25.1)
million for the same period in 2022.
About Entrada TherapeuticsEntrada Therapeutics
is a clinical-stage 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, ENTR-601-45 and
ENTR-601-50 for the potential treatment of people living with
Duchenne who are exon 44, 45 and 50 skipping amenable,
respectively, as well as our partnered candidate ENTR-701 for the
potential treatment of 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 continue to recruit for and complete a healthy
volunteer trial for ENTR-601-44 in the United Kingdom, expectations
regarding the timing of data from its Phase 1 trial for ENTR-601-44
in the second half of 2024, 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 therapeutic
benefits of ENTR-601-44, expectations regarding the timing of
preclinical data results and planned CTA/IND submission for
ENTR-601-50, the continued development and advancement of
ENTR-601-44, ENTR-601-45 and ENTR-601-50 for the treatment of DMD,
ENTR-501 for the treatment of MNGIE, and ENTR-701 for the treatment
of DM1, including the IND-enabling studies, expectations regarding
the expected timing, progress and success of our collaboration with
Vertex, including 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,
statements regarding any future payments Entrada may receive under
the Vertex Agreement, 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 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 September 30, |
|
Nine Months Ended September 30, |
|
|
2023 |
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Collaboration revenue |
|
43,735 |
|
|
— |
|
|
|
87,165 |
|
|
|
— |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
22,191 |
|
|
18,958 |
|
|
|
71,593 |
|
|
|
50,924 |
|
General and administrative |
|
7,532 |
|
|
6,978 |
|
|
|
23,639 |
|
|
|
20,745 |
|
Total operating expenses |
|
29,723 |
|
|
25,936 |
|
|
|
95,232 |
|
|
|
71,669 |
|
Income (loss) from operations |
|
14,012 |
|
|
(25,936 |
) |
|
|
(8,067 |
) |
|
|
(71,669 |
) |
Other income: |
|
|
|
|
|
|
|
Interest and other income |
|
4,051 |
|
|
799 |
|
|
|
10,926 |
|
|
|
1,682 |
|
Total other income |
|
4,051 |
|
|
799 |
|
|
|
10,926 |
|
|
|
1,682 |
|
Income (loss) before benefit from income taxes |
|
18,063 |
|
|
(25,137 |
) |
|
|
2,859 |
|
|
|
(69,987 |
) |
Benefit from income taxes |
|
17,398 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
Net
income (loss) |
|
35,461 |
|
|
(25,137 |
) |
|
|
2,859 |
|
|
|
(69,987 |
) |
Net
income (loss) per share, basic |
$ |
1.07 |
|
$ |
(0.80 |
) |
|
$ |
0.09 |
|
|
$ |
(2.24 |
) |
Net
income (loss) per share, diluted |
$ |
1.02 |
|
$ |
(0.80 |
) |
|
$ |
0.08 |
|
|
$ |
(2.24 |
) |
Weighted‑average common shares outstanding, basic |
|
33,281,287 |
|
|
31,298,052 |
|
|
|
32,942,958 |
|
|
|
31,273,612 |
|
Weighted‑average common shares outstanding, diluted |
|
34,775,451 |
|
|
31,298,052 |
|
|
|
34,289,411 |
|
|
|
31,273,612 |
|
|
|
|
|
|
|
|
|
ENTRADA THERAPEUTICS, INC. |
Condensed Consolidated Balance Sheet Data
(Unaudited) |
(In thousands) |
|
|
September 30,2023 |
|
December 31,2022 |
|
|
Cash, cash equivalents and marketable securities |
$ |
353,578 |
|
$ |
188,712 |
Total assets |
|
485,033 |
|
|
252,056 |
Total liabilities |
|
238,370 |
|
|
39,502 |
Total stockholders’
equity |
|
246,663 |
|
|
212,554 |
|
|
|
|
|
|
Investor and Media ContactKarla MacDonaldChief
Corporate Affairs Officerkmacdonald@entradatx.com
Entrada Therapeutics (NASDAQ:TRDA)
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