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 long considered inaccessible. The Company today reported
financial results for the second quarter ended June 30, 2024, and
highlighted recent business updates.
“In the last quarter, Entrada delivered compelling
Phase 1 clinical data from our Duchenne program ENTR-601-44,
demonstrating the translation of our nonclinical studies to healthy
volunteers. We remain on track to advance separate Phase 2 clinical
trials across multiple Duchenne programs, including those targeting
exon 44, exon 45 and exon 50,” said Dipal Doshi, Chief Executive
Officer at Entrada Therapeutics. “With the completion of a
successful financing that extends our cash runway into 2027, we are
positioned to advance our Duchenne portfolio while expanding into
other disease areas that could benefit from our differentiated
approach to intracellular delivery.”
Recent Corporate Highlights
- In June, Entrada announced positive preliminary data from its
Phase 1 clinical trial of ENTR-601-44-101 for Duchenne muscular
dystrophy (DMD). The study has since been completed with no
drug-related adverse findings noted. ENTR-601-44 was generally
well-tolerated in healthy volunteers with no serious adverse
events, no drug-related adverse events and no clinically
significant changes or trends noted in vital signs,
electrocardiograms, physical exams or laboratory assessments
observed in the trial. The product candidate demonstrated a strong
dose-dependent response, significant plasma concentration, muscle
concentration and exon skipping, at levels that suggest the
potential for a clinically meaningful starting dose in planned
upcoming patient trials. Data will be featured in a poster
presentation at the 29th Annual Congress of the World Muscle
Society, taking place in Prague, Czechia from October 8-12,
2024.
- Planning is underway for separate global Phase 2 clinical
trials for ENTR-601-44 and ENTR-601-45 with regulatory filings
anticipated in Q4 2024. The Company also plans to submit regulatory
applications in 2025 to initiate a global Phase 2 clinical trial
for its third Duchenne candidate, ENTR-601-50, in patients who are
exon 50 skipping amenable.
- The Company completed a $100 million registered direct offering
in June 2024. The proceeds from the offering resulted in the
extension of the Company’s cash runway into 2027.
- Vertex Pharmaceuticals announced that they continue to enroll
and dose patients in the global Phase 1/2 clinical trial for VX-670
in people with DM1 and expect to complete the single ascending dose
(SAD) portion of the study by the end of 2024. Following completion
of the SAD portion of the trial, Vertex will move into the multiple
ascending dose portion, where both the safety and efficacy of
VX-670 will be evaluated.
Upcoming Investor Conferences
The Company will present at the H.C. Wainwright
25th Annual Global Investment Conference in New York, NY on
September 9, 2024.
Second Quarter 2024 Financial
Results
Cash Position: Cash, cash
equivalents and marketable securities were $469.7 million as of
June 30, 2024, compared to $352.0 million as of December 31, 2023.
The increase was primarily a result of the $100 million registered
direct offering completed in June of 2024 and the receipt of the
$75 million payment for the clinical advancement milestone for
VX-670 that was achieved in March of 2024. Based on current
operating plans, the Company believes that its cash, cash
equivalents and marketable securities as of June 30, 2024 will be
sufficient to fund its operations into 2027.
Collaboration Revenue:
Collaboration revenue was $94.7 million for the second quarter of
2024, compared to $18.2 million for the same period in 2023. The
increase was primarily a result of additional VX-670 research
activities performed during the second quarter of 2024 and an
increase in the total transaction price related to the clinical
advancement milestone that was achieved in March of 2024.
Research & Development (R&D)
Expenses: R&D expenses were $32.0 million for the
second quarter of 2024, compared to $26.3 million for the same
period in 2023. The increase was primarily driven by additional
research activities performed for VX-670 and additional preclinical
costs incurred related to ENTR-601-50, as well as higher personnel
costs (including non-cash, stock-based compensation).
General & Administrative (G&A)
Expenses: G&A expenses were $9.2 million for the
second quarter of 2024, compared to $8.2 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
$55.0 million for the second quarter of 2024, compared to a net
loss of $(25.9) 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, the
validation and differentiation of Entrada’s approach and its
ability to provide a potential treatment for patients, the
translatability of the data from the Phase 1 clinical trial for
ENTR-601-44 to future clinical trials for ENTR-601-44, expectations
regarding the ability of Entrada’s preclinical studies and clinical
trials to demonstrate safety and efficacy of its therapeutic
candidates, and other positive results, expectations regarding the
starting dose for Entrada’s planned Phase 2 clinical trial for
ENTR-601-44, expectations regarding the timing of regulatory
filings for the planned Phase 2 clinical trials for ENTR-601-44 and
ENTR-601-45 in the fourth quarter of 2024, and ENTR-601-50 in 2025,
the ability to recruit for and complete global Phase 2 clinical
trials for ENTR-601-44, ENTR-601-45 and ENTR-601-50, the potential
of Entrada’s EEV product candidates, including the potential for
ENTR-601-44 to be a transformative treatment option, and EEV
platform, and the continued development and advancement of
ENTR-601-44, ENTR-601-45 and ENTR-601-50 for the treatment of DMD
and the partnered product candidate VX-670 for the treatment of
myotonic dystrophy type 1, expectations regarding the progress and
success of Entrada’s collaboration with Vertex, including express
and implied statements regarding any future payments Entrada may
receive under the Vertex Agreement, the ability to continue to
expand and develop additional therapeutic programs, including
further exon skipping programs, the potential therapeutic benefits
of its EEV candidates and the ability to advance EEV-therapeutic
candidates in indications beyond neuromuscular disease, and the
sufficiency of its cash resources into 2027, 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 and clinical studies; the timing of and
Entrada’s ability to submit and obtain regulatory clearance and
initiate clinical trials; whether results from preclinical studies
or clinical trials 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, |
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
Collaboration revenue |
|
94,694 |
|
|
|
18,170 |
|
|
|
153,814 |
|
|
|
43,430 |
|
Operating
expenses: |
|
|
|
|
|
|
|
Research and development |
|
32,035 |
|
|
|
26,300 |
|
|
|
60,643 |
|
|
|
49,402 |
|
General and administrative |
|
9,236 |
|
|
|
8,169 |
|
|
|
18,635 |
|
|
|
16,107 |
|
Total operating expenses |
|
41,271 |
|
|
|
34,469 |
|
|
|
79,278 |
|
|
|
65,509 |
|
Income
(loss) from operations |
|
53,423 |
|
|
|
(16,299 |
) |
|
|
74,536 |
|
|
|
(22,079 |
) |
Other
income: |
|
|
|
|
|
|
|
Interest and other income |
|
4,366 |
|
|
|
4,218 |
|
|
|
8,580 |
|
|
|
6,875 |
|
Total other income |
|
4,366 |
|
|
|
4,218 |
|
|
|
8,580 |
|
|
|
6,875 |
|
Income
(loss) before provision for income taxes |
|
57,789 |
|
|
|
(12,081 |
) |
|
|
83,116 |
|
|
|
(15,204 |
) |
Provision for income
taxes |
|
(2,758 |
) |
|
|
(13,847 |
) |
|
|
(4,589 |
) |
|
|
(17,398 |
) |
Net income
(loss) |
|
55,031 |
|
|
|
(25,928 |
) |
|
|
78,527 |
|
|
|
(32,602 |
) |
Net income
(loss) per share, basic |
$ |
1.61 |
|
|
$ |
(0.78 |
) |
|
$ |
2.32 |
|
|
$ |
(0.99 |
) |
Net income
(loss) per share, diluted |
$ |
1.55 |
|
|
$ |
(0.78 |
) |
|
$ |
2.23 |
|
|
$ |
(0.99 |
) |
Weighted‑average common shares outstanding, basic |
|
34,180,549 |
|
|
|
33,163,320 |
|
|
|
33,838,811 |
|
|
|
32,770,989 |
|
Weighted‑average common shares outstanding, diluted |
|
35,507,029 |
|
|
|
33,163,320 |
|
|
|
35,148,221 |
|
|
|
32,770,989 |
|
ENTRADA
THERAPEUTICS, INC. |
Condensed
Consolidated Balance Sheet Data (Unaudited) |
(In
thousands) |
|
|
|
|
|
March
31, 2024 |
|
December
31, 2023 |
|
|
Cash, cash equivalents and marketable securities |
$ |
469,746 |
|
$ |
351,969 |
Total
assets |
|
581,963 |
|
|
469,192 |
Total
liabilities |
|
152,038 |
|
|
226,832 |
Total
stockholders’ equity |
|
429,925 |
|
|
242,360 |
|
|
|
|
|
|
Investor and Media ContactCaileigh
DoughertyHead of Investor Relations & Corporate
Communicationscdougherty@entradatx.com
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