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 fourth
quarter and full year ending December 31, 2022 and highlighted
recent business updates.
“We made significant progress executing on our
strategic initiatives in 2022, highlighted by the expansion of our
pipeline, establishing a global, transformative collaboration with
Vertex focused on discovering and developing intracellular
EEV-therapeutics for myotonic dystrophy type 1 and strengthening
our balance sheet,” said Dipal Doshi, President and Chief Executive
Officer of Entrada Therapeutics. “We are working diligently to
address FDA’s concerns regarding our IND for ENTR-601-44 and remain
very confident in achieving our goal of initiating a healthy
volunteer trial in 2023. Fundamentally, we believe we are
well-positioned to advance our pipeline in the year ahead to create
value for patients and shareholders.”
Recent Corporate Highlights
- In December 2022, the U.S. Food and Drug Administration (FDA)
placed the Investigational New Drug (IND) application on hold for
ENTR-601-44 for the potential treatment of people living with
Duchenne who are amenable to exon 44 skipping, requesting that the
Company gather and submit additional information. The Company is
actively working to resolve the clinical hold as quickly as
possible. Given the extraordinary unmet medical need, Entrada is
simultaneously pursuing global opportunities with the continued
goal of initiating a healthy volunteer trial in 2023.
- In December 2022, the U.S. FDA Office of Orphan Products
Development (OOPD) granted orphan drug designation for ENTR-601-44
for the treatment of Duchenne muscular dystrophy.
- In January 2023, Entrada selected the second clinical candidate
within its Duchenne franchise, ENTR-601-45, for the potential
treatment of people living with Duchenne who are exon 45 skipping
amenable. The Company plans to submit an IND application in the
fourth quarter of 2024.
- In February 2023, Entrada announced the closing of its
strategic collaboration and license agreement with Vertex for the
discovery and development of intracellular EEV-therapeutics for
myotonic dystrophy type 1 (DM1). The collaboration includes
ENTR-701, which is in late-stage preclinical development. Under the
terms of the agreement, Entrada received an upfront payment of $224
million, as well as an equity investment of $26 million in February
2023. Entrada is eligible to receive up to $485 million 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 the collaboration
agreement.
Upcoming Events
The Company will present at the following events
during the first quarter of 2023:
- Cowen 43rd Annual Health Care Conference in Boston, MA. Dipal
Doshi will join the Neuromuscular and Bone Corporate Panel on March
8, 2023 at 2:10 p.m. EST.
- Muscular Dystrophy Association (MDA) Clinical & Scientific
Conference 2023 in Dallas, TX from March 19-22, 2023.
Fourth Quarter and Full Year 2022
Financial Results
Cash Position: Cash, cash
equivalents and marketable securities were $188.7 million as
of December 31, 2022, compared to $215.6 million as of September
30, 2022 and $291.1 million as of December 31, 2021. The
Company anticipates that its existing cash, cash equivalents and
marketable securities, together with the proceeds received under
the Vertex Agreement, ongoing research support and the anticipated
achievement of certain near-term milestones under the Vertex
Agreement will be sufficient to extend our cash runway into the
second half of 2025, supporting the Company’s expansion and
continued development of EEV-therapeutic candidates targeting
Duchenne as well as other indications beyond neuromuscular
diseases.
Research & Development (R&D)
Expenses: R&D expenses were $15.7 million for the
fourth quarter of 2022 and $66.6 million for the full year of
2022, compared to $12.4 million and $35.9 million for the
same periods in 2021, respectively. This increase was primarily due
to additional investment in preclinical 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 $9.9 million for the
fourth quarter of 2022 and $30.6 million for the full year of
2022, compared to $6.1 million and $15.2 million for the
same periods in 2021, respectively. This increase was primarily due
to higher personnel costs (including non-cash stock-based
compensation), legal costs and other costs associated with Entrada
operating as a public company.
Net Loss: Net loss was
$24.6 million for the fourth quarter of 2022 and
$94.6 million for the full year of 2022, compared to net loss
of $18.4 million and $51.2 million for the same periods
of 2021, respectively.
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 Twitter and 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, express
or implied statements regarding the clinical hold on the IND for
ENTR-601-44, expectations regarding the timing and outcome of the
Company’s discussions with the FDA regarding the clinical hold on
the IND for ENTR-601-44, the Company’s ability to address the FDA’s
concerns regarding its IND for ENTR-601-44, the timing of the
Company’s Phase 1 single ascending dose trial for ENTR-601-44 and
initial clinical readout for such trial, the ability to enroll
patients and achieve successful results in ENTR-601-44 clinical
trials, the potential benefits and results that may be achieved
through Entrada’s collaboration with Vertex, Entrada’s expectations
of the use of proceeds from its collaboration with Vertex,
expectations regarding the findings from preclinical data of the
Company’s therapeutic candidates, 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
Investigational New Drug (IND) application-enabling studies, the
timing of Entrada's planned regulatory filings regarding its
development programs, including the planned IND submission for
ENTR-601-45, the ability to develop additional exon skipping
programs, the potential therapeutic benefits of its EEV candidates,
and the sufficiency of its cash resources into the second half of
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; the timing of and Entrada’s
ability to submit and obtain regulatory clearance for IND
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 December 31, |
|
Twelve
Months Ended December 31, |
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
Research and development |
$ |
15,685 |
|
|
$ |
12,362 |
|
|
$ |
66,609 |
|
|
$ |
35,926 |
|
General and administrative |
|
9,894 |
|
|
|
6,098 |
|
|
|
30,639 |
|
|
|
15,201 |
|
Total operating expenses |
|
25,579 |
|
|
|
18,460 |
|
|
|
97,248 |
|
|
|
51,127 |
|
Loss from
operations |
|
(25,579 |
) |
|
|
(18,460 |
) |
|
|
(97,248 |
) |
|
|
(51,127 |
) |
Other income
(expense): |
|
|
|
|
|
|
|
Interest and other income (expense), net |
|
950 |
|
|
|
13 |
|
|
|
2,632 |
|
|
|
(31 |
) |
Total other income (expense), net |
|
950 |
|
|
|
13 |
|
|
|
2,632 |
|
|
|
(31 |
) |
Net
loss |
$ |
(24,629 |
) |
|
$ |
(18,447 |
) |
|
$ |
(94,616 |
) |
|
$ |
(51,158 |
) |
Net loss per
share attributable to common stockholders, basic and diluted |
$ |
(0.79 |
) |
|
$ |
(0.89 |
) |
|
$ |
(3.02 |
) |
|
$ |
(8.16 |
) |
Weighted‑average common shares outstanding, basic and diluted |
|
31,351,770 |
|
|
|
20,779,674 |
|
|
|
31,293,312 |
|
|
|
6,267,776 |
|
ENTRADA THERAPEUTICS, INC.
Condensed Consolidated Balance Sheet Data
(Unaudited) (In thousands)
|
|
December
31, 2022 |
|
December
31, 2021 |
|
|
Cash and cash equivalents |
|
$ |
45,157 |
|
$ |
291,064 |
Marketable
securities |
|
|
143,555 |
|
|
— |
Total
assets |
|
|
252,056 |
|
|
305,833 |
Total
liabilities |
|
|
39,502 |
|
|
7,115 |
Total
stockholders’ equity |
|
|
212,554 |
|
|
298,718 |
Investor and Media Contact Karla
MacDonald Chief Corporate Affairs Officer
kmacdonald@entradatx.com
Entrada Therapeutics (NASDAQ:TRDA)
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