Dyne Therapeutics Reports Second Quarter 2023 Financial Results and Business Highlights
03 Agosto 2023 - 8:30AM
Dyne Therapeutics, Inc. (Nasdaq: DYN), a clinical-stage muscle
disease company focused on advancing innovative life-transforming
therapeutics for people living with genetically driven diseases,
today reported financial results for the second quarter of 2023 and
business highlights.
“This is an exciting time for the entire Dyne team as we
continue to enroll and dose patients in our ACHIEVE and DELIVER
trials and are on track to report our first clinical data from both
during the second half of this year, including evaluating important
biomarkers of splicing in DM1 and dystrophin in DMD,” said Joshua
Brumm, president and chief executive officer of Dyne. “In addition
to progressing our clinical programs, we were also pleased to
present preclinical data at ASGCT in May demonstrating the FORCE™
platform achieved TfR1-mediated delivery to the CNS, building on
previous work showing delivery to skeletal, smooth and cardiac
muscle in multiple well-validated preclinical models. CNS symptoms
contribute significantly to the burden of neuromuscular disease,
and we look forward to further exploring this application of the
FORCE platform. Our commitment to advancing the treatment and care
of individuals living with rare muscle diseases continues to drive
our efforts with a sense of urgency.”
Business Highlights
- Enrollment continues in ACHIEVE, a Phase 1/2 global clinical
trial evaluating DYNE-101 in adult patients with myotonic dystrophy
type 1 (DM1). ACHIEVE, which is designed to be a registrational
trial, consists of a 24-week multiple ascending dose (MAD),
randomized, placebo-controlled period, a 24-week open-label
extension and a 96-week long-term extension. The primary endpoints
are safety and tolerability, with secondary endpoints of
pharmacokinetics and pharmacodynamics, including change from
baseline in splicing, as well as measures of muscle strength and
function.
- Enrollment continues in DELIVER, a Phase 1/2 global clinical
trial evaluating DYNE-251 in males with Duchenne muscular dystrophy
(DMD) who have mutations amenable to exon 51 skipping. DELIVER,
which is designed to be a registrational trial, consists of a
24-week MAD, randomized, placebo-controlled period, a 24-week
open-label extension and a 96-week long-term extension. The primary
endpoints are safety, tolerability and change from baseline in
dystrophin levels as measured by Western blot. Secondary endpoints
include measures of muscle function, exon skipping and
pharmacokinetics.
- New preclinical data were featured in an oral presentation
at the American Society of Gene & Cell Therapy (ASGCT) 26th
Annual Meeting in May 2023 demonstrating the FORCE platform
achieved delivery to the central nervous system (CNS) in non-human
primates and robust pharmacological effects in the brain in a model
of DM1.
- The European Medicines Agency (EMA) granted orphan drug
designation for DYNE-101 in DM1 in May 2023.
Key 2023 Milestones
- Dyne anticipates reporting initial data in the second half of
2023 from:
- the MAD placebo-controlled portion of the ACHIEVE trial of
DYNE-101 in DM1 on safety, tolerability and splicing; and
- the MAD placebo-controlled portion of the DELIVER trial of
DYNE-251 in DMD on safety, tolerability and dystrophin.
Second Quarter 2023 Financial Results
Cash position: Cash, cash equivalents and
marketable securities were $207.7 million as of June 30, 2023,
which is anticipated to fund operations through 2024.
Research and development (R&D) expenses:
R&D expenses were $59.1 million for the quarter ended June 30,
2023, compared to $46.7 million for the quarter ended June 30,
2022.
General and administrative (G&A) expenses:
G&A expenses were $7.6 million for the quarter ended June 30,
2023, compared to $6.1 million for the quarter ended June 30,
2022.
Net loss: Net loss for the quarter ended June
30, 2023 was $64.9 million, or $1.08 per basic and diluted share.
This compares with a net loss of $52.3 million, or $1.01 per basic
and diluted share, for the quarter ended June 30, 2022.
About Dyne Therapeutics
Dyne Therapeutics is a clinical-stage muscle disease company
focused on advancing innovative life-transforming therapeutics for
people living with genetically driven diseases. With its
proprietary FORCE™ platform, Dyne is developing modern
oligonucleotide therapeutics that are designed to overcome
limitations in delivery to muscle tissue. Dyne has a broad pipeline
for serious muscle diseases, including clinical programs for
myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy
(DMD) and a preclinical program for facioscapulohumeral muscular
dystrophy (FSHD). For more information, please visit
https://www.dyne-tx.com/, and follow us on Twitter, LinkedIn and
Facebook.
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 Dyne’s strategy, future
operations, prospects and plans, objectives of management, the
potential of the FORCE platform, the anticipated timelines for
reporting data from the DYNE-251 and DYNE-101 clinical trials, the
trial design of the DYNE-251 and DYNE-101 clinical trials, and the
sufficiency of Dyne’s existing cash resources for the period
anticipated, 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. Dyne
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 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 Dyne’s ability to initiate and
enroll patients in clinical trials; whether results from
preclinical studies will be predictive of the results of later
preclinical studies and clinical trials; whether Dyne’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
Dyne’s filings with the Securities and Exchange Commission (SEC),
including the Company’s most recent Form 10-Q and in subsequent
filings Dyne may make with the SEC. In addition, the
forward-looking statements included in this press release represent
Dyne’s views as of the date of this press release. Dyne anticipates
that subsequent events and developments will cause its views to
change. However, while Dyne 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 Dyne’s views as of any date subsequent to the date of
this press release.
|
|
Dyne Therapeutics, Inc. |
|
Condensed Consolidated Statement of Operations
(Unaudited) |
|
(in thousands, except share and per share
data) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
59,130 |
|
|
$ |
46,664 |
|
|
$ |
96,667 |
|
|
$ |
74,899 |
|
General and administrative |
|
|
7,606 |
|
|
|
6,091 |
|
|
|
15,533 |
|
|
|
13,638 |
|
Total operating expenses |
|
|
66,736 |
|
|
|
52,755 |
|
|
|
112,200 |
|
|
|
88,537 |
|
Loss from operations |
|
|
(66,736 |
) |
|
|
(52,755 |
) |
|
|
(112,200 |
) |
|
|
(88,537 |
) |
Other (expense) income, net |
|
|
1,834 |
|
|
|
451 |
|
|
|
3,111 |
|
|
|
650 |
|
Net loss |
|
$ |
(64,902 |
) |
|
$ |
(52,304 |
) |
|
$ |
(109,089 |
) |
|
$ |
(87,887 |
) |
Net loss per share—basic and
diluted |
|
$ |
(1.08 |
) |
|
$ |
(1.01 |
) |
|
$ |
(1.88 |
) |
|
$ |
(1.70 |
) |
Weighted-average common shares
outstanding used in net loss per share—basic and diluted |
|
|
59,835,087 |
|
|
|
51,679,536 |
|
|
|
58,090,142 |
|
|
|
51,640,706 |
|
Dyne Therapeutics, Inc. |
|
Condensed Consolidated Balance Sheet Data
(Unaudited) |
|
(in thousands) |
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2023 |
|
|
2022 |
|
Assets |
|
|
|
|
|
|
Cash, cash equivalents and marketable securities |
|
$ |
207,733 |
|
|
$ |
256,012 |
|
Other assets |
|
|
43,688 |
|
|
|
50,313 |
|
Total assets |
|
$ |
251,421 |
|
|
$ |
306,325 |
|
Liabilities and
Stockholders’ Equity |
|
|
|
|
|
|
Liabilities |
|
|
44,544 |
|
|
|
53,961 |
|
Stockholders’ equity |
|
|
206,877 |
|
|
|
252,364 |
|
Total liabilities and stockholders’ equity |
|
$ |
251,421 |
|
|
$ |
306,325 |
|
|
|
Contacts:
InvestorsAmy
Reillyareilly@dyne-tx.com857-341-1203
MediaStacy
Nartkersnartker@dyne-tx.com781-317-1938
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