Dyne Therapeutics Reports Fourth Quarter and Full Year 2020 Financial Results and Recent Highlights
March 04 2021 - 7:35AM
Dyne Therapeutics, Inc. (Nasdaq: DYN), a muscle disease company
focused on advancing innovative life-transforming therapeutics for
people living with genetically driven diseases, today reported
financial results for the fourth quarter and full year 2020 and
recent business highlights.
“2020 was a transformational year for Dyne. We
delivered validating data for our FORCE™ platform and
programs, further strengthened our exceptional team with
the addition of highly experienced leaders and completed our
IPO. Together with earlier financings in 2020 and the
follow-on public offering completed in January 2021, we have raised
more than $550 million, which we expect to support us into the
second half of 2024. We begin 2021 focused on driving our DM1,
DMD and FSHD programs to the clinic as we pursue our goal
of delivering potentially life-transforming therapies to people
living with serious muscle diseases,” said Joshua Brumm, president
and chief executive officer of Dyne.
Recent Highlights
- In January 2021, Dyne announced new
preclinical data from its myotonic dystrophy type 1 (DM1) program
demonstrating robust RNA knockdown of toxic human nuclear DMPK, the
genetic basis of the disease. To assess the ability of its lead DM1
candidate to reduce toxic human nuclear DMPK RNA, Dyne developed an
innovative hTfR1/DMSXL mouse model that expresses the human TfR1
(hTfR1) and carries a human DMPK gene that represents a severe DM1
phenotype with more than 1,000 CTG repeats. In this model, two
doses (2 x 10 mg/kg) of Dyne’s candidate resulted in significant
toxic human nuclear DMPK knockdown at 14 days: 60 percent in the
heart; 56 percent in the diaphragm; 54 percent in the tibialis
anterior and 39 percent in the gastrocnemius. In the study, Dyne’s
candidate was well tolerated. Dyne expects to share data from the
hTfR1/DMSXL model at a scientific meeting during 2021.
- The Company further strengthened its
leadership team with the appointment of Wildon Farwell, M.D., MPH,
as chief medical officer, announced separately today, and Ashish
Dugar, Ph.D., MBA, as senior vice president, global head of medical
affairs, in February 2021.
- In January 2021, Dyne completed its follow-on public offering
of 6,000,000 shares of its common stock at a public offering price
of $28.00 per share. Gross proceeds of the offering before
deducting the underwriting discount and commissions and offering
expenses were approximately $168 million. Dyne expects its cash,
cash equivalents and marketable securities as of December 31, 2020,
together with the net proceeds from the January 2021 public
offering, will be sufficient to fund its operating expenses and
capital expenditure requirements into the second half of 2024.
Upcoming Scientific & Investor Conference
Presentations
- Dyne is scheduled to participate in the 2021 MDA Virtual
Clinical & Scientific Conference. Romesh Subramanian, Ph.D.,
chief scientific officer, will present as part of the panel
“Therapeutic Considerations for Dominant Neuromuscular Diseases,”
and Oxana Beskrovnaya, Ph.D., senior vice president, head of
research, will participate in the “Non-viral Delivery in
Neuromuscular Disease” session. Both presentations will take place
on March 15, 2021 and will be available to registered attendees at:
https://mdavirtualconference.org/.
- Dr. Beskrovnaya also intends to present on Dyne’s FORCE
platform during the virtual 7th Cold Spring Harbor Laboratory
meeting on Nucleic Acid Therapies on March 24, 2021, which is
accessible to registered participants at:
https://meetings.cshl.edu/meetings.aspx?meet=NAT&year=21.
- Mr. Brumm and Dr. Subramanian are scheduled to participate in a
virtual fireside chat during Stifel’s 3rd Annual CNS Day on April
1, 2021 at 10:30 am ET. A live webcast will be available in the
Investors & Media section of Dyne’s website
at https://investors.dyne-tx.com/investors-and-media and a
replay will be accessible for 90 days following the
presentation.
Fourth Quarter and Full Year 2020 Financial
Results
Cash position: Cash, cash equivalents and
marketable securities were $345.3 million as of December 31, 2020.
Additionally, in January 2021, Dyne completed a public offering of
common stock, with gross proceeds totaling approximately $168
million.
Research and development (R&D) expenses:
R&D expenses were $22.1 million and $4.3 million for the
quarters ended December 31, 2020 and 2019, respectively. R&D
expenses were $45.2 million and $11.0 million for the years ended
December 31, 2020 and 2019, respectively.
General and administrative (G&A) expenses:
G&A expenses were $6.5 million and $1.2 million for the
quarters ended December 31, 2020 and 2019, respectively. G&A
expenses were $13.4 million and $2.8 million for the years ended
December 31, 2020 and 2019, respectively.
Net loss: Net loss for the quarter ended
December 31, 2020 was $28.6 million, or $0.64 per basic and diluted
share. This compares with a net loss of $5.4 million, or $2.10 per
basic and diluted share, for the quarter ended December 31, 2019.
Net loss for the year ended December 31, 2020 was $59.4 million, or
$4.13 per basic and diluted share. This compares with a net loss of
$14.9 million, or $6.08 per basic and diluted share, for the year
ended December 31, 2020.
About Dyne Therapeutics
Dyne Therapeutics is building a leading muscle disease company
dedicated to 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 seen with other
approaches. Dyne’s broad portfolio of therapeutic candidates
for serious muscle diseases includes programs for
myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy
(DMD) and 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, plans, objectives of management, the
expected timeline for submitting investigational new drug
applications and achieving proof-of-concept data readouts and the
sufficiency of its cash resources, 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 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 Dyne’s ability to submit
investigational new drug applications; whether results from
preclinical studies will be predictive of the results of later
preclinical studies and clinical trials; uncertainties related to
Dyne’s ability to obtain sufficient cash resources to fund the
Company’s foreseeable and unforeseeable operating expenses and
capital expenditure requirements for the anticipated periods; the
impact of the COVID-19 pandemic on Dyne’s business and operations;
as well as the risks and uncertainties identified in Dyne’s filings
with the Securities and Exchange Commission (SEC), including the
Company’s Annual Report on Form 10-K for the year ended December
31, 2020 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.
Contact:
Dyne TherapeuticsAmy Reillyareilly@dyne-tx.com 857-341-1203
Dyne Therapeutics, Inc. |
Condensed Consolidated Statement of
Operations |
(in thousands, except share and per share
data) |
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended December 31, |
|
Year Ended December 31, |
|
|
|
2020 |
|
|
|
2019 |
|
|
|
2020 |
|
|
|
2019 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research
and development |
|
$ |
22,098 |
|
|
$ |
4,259 |
|
|
$ |
45,200 |
|
|
$ |
11,040 |
|
General
and administrative |
|
|
6,502 |
|
|
|
1,211 |
|
|
|
13,447 |
|
|
|
2,786 |
|
Total operating expenses |
|
|
28,600 |
|
|
|
5,470 |
|
|
|
58,647 |
|
|
|
13,826 |
|
Loss
from operations |
|
|
(28,600 |
) |
|
|
(5,470 |
) |
|
|
(58,647 |
) |
|
|
(13,826 |
) |
Other
(expense) income |
|
|
(49 |
) |
|
|
67 |
|
|
|
(790 |
) |
|
|
(1,033 |
) |
Net loss |
|
$ |
(28,649 |
) |
|
$ |
(5,403 |
) |
|
$ |
(59,437 |
) |
|
$ |
(14,859 |
) |
Net loss
per share—basic and diluted |
|
$ |
(0.64 |
) |
|
$ |
(2.10 |
) |
|
$ |
(4.13 |
) |
|
$ |
(6.08 |
) |
Weighted-average common shares outstanding used in net loss
per share—basic and diluted |
|
|
45,058,494 |
|
|
|
2,567,007 |
|
|
|
14,395,955 |
|
|
|
2,442,872 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dyne Therapeutics, Inc. |
Condensed Consolidated Balance Sheet Data |
(in thousands) |
|
|
|
|
|
|
|
December 31, |
|
December 31, |
|
|
2020 |
|
2019 |
Assets |
|
|
|
|
Cash, cash equivalents and marketable securities |
|
$ |
345,314 |
|
$ |
14,632 |
Other assets |
|
|
8,020 |
|
|
1,804 |
Total
assets |
|
$ |
353,334 |
|
$ |
16,436 |
Liabilities and
Stockholders’ Equity |
|
|
|
|
Liabilities |
|
|
10,967 |
|
|
2,400 |
Stockholders’ equity |
|
|
342,367 |
|
|
14,036 |
Total liabilities and
stockholders’ equity |
|
$ |
353,334 |
|
$ |
16,436 |
|
|
|
|
|
|
|
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