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 fourth quarter and full
year ending December 31, 2023, and highlighted recent business
updates.
“We continue to make significant progress
advancing our growing pipeline of intracellular therapeutics,” said
Dipal Doshi, Chief Executive Officer of Entrada Therapeutics. “We
have an exciting year ahead in 2024, with several important
clinical milestones within our Duchenne franchise, including the
expected fourth quarter submissions of Phase 2 regulatory
applications for the global development of ENTR-601-44 and
ENTR-601-45. Clinical momentum is also building in our
collaboration with Vertex, with the initiation of a Phase 1/2
clinical trial of VX-670 in patients with DM1. With the extension
of our cash runway through the second quarter of 2026, we believe
we are well positioned to progress our Duchenne franchise and
broader pipeline to create value for patients and
shareholders.”
Recent Corporate Highlights
- Completed dosing for the first three cohorts 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 plans to announce data from the clinical
trial in the second half of 2024. Additionally, the Company expects
to submit regulatory applications in the fourth quarter of 2024 for
the separate global Phase 2 clinical development of ENTR-601-44 in
Duchenne patients who are exon 44 skipping amenable and ENTR-601-45
in Duchenne patients who are exon 45 skipping amenable.
- Vertex Pharmaceuticals announced it received clearances from
Health Canada and Medicines and Healthcare Products Regulatory
Agency (MHRA) in the United Kingdom for Clinical Trial Applications
for VX-670 for patients with myotonic dystrophy type 1 (DM1).
Vertex initiated the Phase 1/2 clinical trial in patients with DM1
in Canada and will initiate the study in the UK
near-term.
- In January 2024, Entrada announced the promotion of Nathan
Dowden, previously Chief Operating Officer of Entrada Therapeutics,
to President and Chief Operating Officer. Mr. Dowden has played a
critical role in developing Entrada’s strategic and operational
capabilities. In February 2024, the Company appointed Kevin Healy,
PhD, as Senior Vice President of Regulatory Affairs. Mr. Healy has
extensive expertise in the development and commercialization of
therapies for serious and rare diseases and has led or participated
in more than 30 formal meetings with the FDA, EMA, and other global
health authorities. In March 2024, Entrada appointed Marie
Rosenfeld as Senior Vice President of Clinical Operations and Data
Management. Ms. Rosenfeld has more than 20 years of experience in
R&D at large and medium-size pharmaceutical companies and
contract research organizations, with a proven track record of
securing product regulatory approvals.
Fourth Quarter and Full Year 2023
Financial Results
Cash Position: Cash, cash
equivalents and marketable securities were $352.0 million as of
December 31, 2023, compared to $188.7 million as of December 31,
2022. This increase was primarily due to the proceeds received to
date from the Vertex Agreement. Entrada anticipates that its cash,
cash equivalents and marketable securities as of December 31,
2023, together with ongoing research support and the anticipated
achievement of certain milestones pursuant to the Vertex
collaboration, will be sufficient to fund the Company's operating
expenses and capital expenditure requirements through the second
quarter of 2026.
Collaboration Revenue:
Collaboration revenue was $41.8 million for the fourth quarter of
2023 and $129.0 million for the full year of 2023. There was no
collaboration revenue in the fourth quarter or full year of
2022.
Research & Development (R&D)
Expenses: R&D expenses were $28.3 million for the
fourth quarter of 2023 and $99.9 million for the full year of 2023,
compared to $15.7 million and $66.6 million for the same periods in
2022, respectively. The increases were primarily due to the
initiation of the 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 $8.7 million for the
fourth quarter of 2023 and $32.3 million for the full year of 2023,
compared to $9.9 million and $30.6 million for the same periods in
2022, respectively. The G&A expenses in the fourth quarter of
2023 were lower than the fourth quarter of 2022 primarily due to a
decrease in legal and consulting fees. The increase in the full
year expense was primarily due to higher personnel costs (including
non-cash stock-based compensation).
Net Income (Loss): Net loss was
$9.5 million for the fourth quarter of 2023 and $6.7 million for
the full year of 2023, compared to a net loss of $24.6 million and
$94.6 million for the same periods in 2022, respectively.
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
United Kingdom 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
United Kingdom, 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, ENTR-601-45
and ENTR-601-50 for the treatment of Duchenne 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 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,
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 December 31, |
|
Twelve Months Ended December 31, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Collaboration revenue |
$ |
41,848 |
|
|
$ |
— |
|
|
$ |
129,013 |
|
|
$ |
— |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
28,291 |
|
|
|
15,685 |
|
|
|
99,884 |
|
|
|
66,609 |
|
General and administrative |
|
8,652 |
|
|
|
9,894 |
|
|
|
32,291 |
|
|
|
30,639 |
|
Total operating expenses |
|
36,943 |
|
|
|
25,579 |
|
|
|
132,175 |
|
|
|
97,248 |
|
Income (loss) from operations |
|
4,905 |
|
|
|
(25,579 |
) |
|
|
(3,162 |
) |
|
|
(97,248 |
) |
Other income: |
|
|
|
|
|
|
|
Interest and other income |
|
4,292 |
|
|
|
950 |
|
|
|
15,218 |
|
|
|
2,632 |
|
Total other income |
|
4,292 |
|
|
|
950 |
|
|
|
15,218 |
|
|
|
2,632 |
|
Income (loss) before provision for income taxes |
|
9,197 |
|
|
|
(24,629 |
) |
|
|
12,056 |
|
|
|
(94,616 |
) |
Provision for income taxes |
|
(18,741 |
) |
|
|
— |
|
|
|
(18,741 |
) |
|
|
— |
|
Net loss |
$ |
(9,544 |
) |
|
$ |
(24,629 |
) |
|
$ |
(6,685 |
) |
|
$ |
(94,616 |
) |
Net loss per share attributable to common stockholders, basic and
diluted |
$ |
(0.29 |
) |
|
$ |
(0.79 |
) |
|
$ |
(0.20 |
) |
|
$ |
(3.02 |
) |
Weighted‑average common shares outstanding, basic and diluted |
|
33,368,901 |
|
|
|
31,351,770 |
|
|
|
33,050,319 |
|
|
|
31,293,312 |
|
ENTRADA THERAPEUTICS, INC. Condensed
Consolidated Balance Sheet Data (Unaudited) (In
thousands) |
|
December 31, 2023 |
|
December 31, 2022 |
Cash, cash equivalents and marketable securities |
$ |
351,969 |
|
$ |
188,712 |
Total assets |
469,192 |
|
252,056 |
Total liabilities |
226,832 |
|
39,502 |
Total stockholders’ equity |
242,360 |
|
212,554 |
Investor and Media Contact Karla
MacDonald Chief Corporate Affairs Officer
kmacdonald@entradatx.com
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