Design Therapeutics Announces Business Highlights and Reports First Quarter 2021 Financial Results
May 10 2021 - 4:05PM
Design Therapeutics, Inc. (Nasdaq: DSGN), a biotechnology company
developing treatments for degenerative genetic disorders, today
reported business highlights and first quarter 2021 financial
results.
“2021 has been a meaningful year so far for Design, with marked
progress across our proprietary gene targeted chimera (GeneTACTM)
platform, our small molecule pipeline, and our business
operations,” said João Siffert, M.D., president and chief executive
officer of Design Therapeutics. “We transitioned to a public
company and stand well-capitalized to fuel the continued
advancement of our platform, led by the development of a
potentially disease-modifying treatment for people living with
Friedreich ataxia, a debilitating autosomal-recessive genetic
disease. Following a recent successful pre-IND meeting with the
FDA, we remain on track to initiate clinical development for our FA
program in the first half of 2022 and make the important
transformation to a clinical-stage organization.”
Business Highlights
- On-track with Clinical
Development Plans for Friedreich Ataxia Program Following Pre-IND
Meeting with FDA: Design Therapeutics successfully
completed a pre-Investigational New Drug (IND) meeting with the
U.S. Food and Drug Administration (FDA) regarding the preclinical
and clinical development plans for its lead GeneTAC program for the
treatment of Friedreich ataxia (FA). As part of the meeting, Design
gained alignment with the FDA on its development plans and, pending
regulatory approval, is preparing to initiate a Phase 1 clinical
trial in patients with FA in the first half of 2022. FA is a
devastating disease for which more than 95% of cases are caused by
homozygous guanine-adenine-adenine (GAA) triplet repeat expansions
in the first intron of the FXN gene.
- Myotonic Dystrophy Type-1
Program Advancing as Planned: Design’s second GeneTAC
program is focused on the development of a potentially
disease-modifying treatment for myotonic dystrophy type-1 (DM1).
The company is advancing its DM1 GeneTAC program, with plans to
seek regulatory clearance for a first-in-human trial in 2023.
- $276 Million Initial Public
Offering (IPO) Successfully Completed: In March 2021,
Design sold 13,800,000 shares of its common stock, which included
1,800,000 shares sold pursuant to the exercise in full by the
underwriters of their option to purchase additional shares, at a
public offering price of $20.00 per share. Including the option
exercise, the aggregate gross proceeds to Design from the offering
were $276.0 million, before deducting the underwriting discounts
and commissions and offering expenses.
First Quarter 2021 Financial Results
For the first quarter ended March 31, 2021, Design reported
a net loss of $5.5 million, compared to a net loss of $0.7 million
for the comparable period in 2020.
Research and development expenses for the first quarter of 2021
were $3.9 million, compared to $0.4 million for the comparable
period in 2020. The increase in the company’s research and
development expenses in 2021 was primarily attributable to the
advancement of its FA program and related activities, including
chemistry and manufacturing development costs, and costs incurred
on its DM1 program in 2021 that were not incurred in 2020. Further
the company incurred higher personnel costs to support its
development programs, including an additional $0.2 million of
non-cash stock-based compensation costs.
General and administrative expenses for the first quarter of
2021, were $1.8 million, compared to $0.4 million for the
comparable period in 2020. The increase in general and
administrative expenses in 2021 was primarily attributable to
increased personnel and related costs as the company expanded its
general and administrative team to support its operations,
including an additional $0.5 million of non-cash stock-based
compensation costs. Further, the company incurred increased
professional fees for legal and accounting services during the
first quarter of 2021 as compared to same period in 2020.
As of March 31, 2021, Design reported cash, cash
equivalents and investment securities of $411.3 million, an
increase of $375.2 million from the $36.1 million reported as of
December 31, 2020. The increase during the first quarter of
2021 was attributed to the net proceeds from the company’s IPO in
March 2021 and its Series B convertible preferred stock financing
in January 2021.
About Design TherapeuticsDesign Therapeutics is
a biotechnology company developing a new class of therapies based
on a platform of gene targeted chimera (GeneTAC™) small molecules.
Our GeneTAC molecules are designed to either turn on or turn off a
specific disease-causing gene to address the underlying cause of
disease. The company’s lead program is focused on the treatment of
Friedreich ataxia, followed by a program in myotonic dystrophy
type-1 and discovery efforts for multiple other serious
degenerative disorders caused by nucleotide repeat expansions. For
more information, please visit designtx.com.
Forward Looking StatementsStatements in this
press release that are not purely historical in nature are
"forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995. These statements include,
but are not limited to, statements related to: the progress and
expected timing of Design’s development programs and any clinical
trials; the effectiveness of Design’s GeneTAC program in the
treatment of Friedreich ataxia and myotonic dystrophy type-1; the
potential advantages of these GeneTAC programs; and the strength of
Design’s balance sheet and the adequacy of cash on hand. Because
such statements are subject to risks and uncertainties, actual
results may differ materially from those expressed or implied by
such forward-looking statements. Words such as "believes,"
"anticipates," "plans," "expects," "intends," "will," "goal,"
"potential" and similar expressions are intended to identify
forward-looking statements. These forward-looking statements are
based upon Design’s current expectations and involve assumptions
that may never materialize or may prove to be incorrect. Actual
results and the timing of events could differ materially from those
anticipated in such forward-looking statements as a result of
various risks and uncertainties, which include, without limitation,
risks associated with the process of discovering, developing and
commercializing therapies that are safe and effective for use as
human therapeutics and operating as a development stage company;
Design’s ability to develop, initiate or complete preclinical
studies and clinical trials for, obtain approvals for and
commercialize any of its product candidates; the risk that
promising early research or clinical trials do not demonstrate
safety and/or efficacy in later preclinical studies or clinical
trials; the risk that Design may not obtain approval to market its
product candidates; uncertainties associated with performing
clinical trials, regulatory filings and applications; risks
associated with reliance on third parties to successfully conduct
clinical trials; changes in Design’s plans to develop and
commercialize its product candidates; Design’s ability to raise any
additional funding it will need to continue to pursue its business
and product development plans; regulatory developments in the
United States and foreign countries; Design’s reliance on key third
parties, including contract manufacturers and contract research
organizations; Design’s ability to obtain and maintain intellectual
property protection for its product candidates; the loss of key
scientific or management personnel; competition in the industry in
which Design operates; and market conditions. For a more detailed
discussion of these and other factors, please refer to Design’s
filings with the Securities and Exchange Commission. You are
cautioned not to place undue reliance on these forward-looking
statements, which speak only as of the date hereof. All
forward-looking statements are qualified in their entirety by this
cautionary statement and Design undertakes no obligation to revise
or update this press release to reflect events or circumstances
after the date hereof, except as required by law.
Contact:Alicia DavisTHRUST Strategic
Communications(910) 620-3302alicia@thrustsc.com
|
DESIGN THERAPEUTICS, INC.STATEMENTS OF
OPERATIONS |
(in thousands, except share and per share
data)(unaudited) |
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
2021 |
|
|
2020 |
|
Revenue: |
|
|
|
|
|
|
|
|
Grant revenue |
|
$ |
— |
|
|
$ |
142 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
3,875 |
|
|
|
377 |
|
General and administrative |
|
|
1,805 |
|
|
|
388 |
|
Total operating expenses |
|
|
5,680 |
|
|
|
765 |
|
Loss from operations |
|
|
(5,680 |
) |
|
|
(623 |
) |
Other income (expense), net |
|
|
166 |
|
|
|
(40 |
) |
Net loss |
|
$ |
(5,514 |
) |
|
$ |
(663 |
) |
|
|
|
|
|
|
|
|
|
Net loss per share, basic and
diluted |
|
$ |
(0.31 |
) |
|
$ |
(0.04 |
) |
Weighted-average shares of common
stock outstanding, basic and diluted |
|
|
17,630,178 |
|
|
|
15,667,115 |
|
|
|
|
|
|
|
|
|
|
|
DESIGN THERAPEUTICS, INC.BALANCE
SHEETS |
(in thousands)(unaudited) |
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2021 |
|
|
2020 |
|
|
|
(unaudited) |
|
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash, cash equivalents and investment securities |
|
$ |
411,339 |
|
|
$ |
36,091 |
|
Prepaid expense and other current assets |
|
|
415 |
|
|
|
142 |
|
Total current assets |
|
|
411,754 |
|
|
|
36,233 |
|
Property and equipment, net |
|
|
100 |
|
|
|
71 |
|
Deferred offering costs |
|
|
— |
|
|
|
212 |
|
Total assets |
|
$ |
411,854 |
|
|
$ |
36,516 |
|
Liabilities, Convertible
Preferred Stock and Stockholders’ Equity (Deficit) |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
2,033 |
|
|
$ |
1,399 |
|
Accrued expenses |
|
|
1,673 |
|
|
|
931 |
|
Total current liabilities |
|
|
3,706 |
|
|
|
2,330 |
|
Other long-term liabilities |
|
|
142 |
|
|
|
145 |
|
Total liabilities |
|
|
3,848 |
|
|
|
2,475 |
|
Convertible preferred stock |
|
|
— |
|
|
|
45,356 |
|
Total stockholders’ equity
(deficit) |
|
|
408,006 |
|
|
|
(11,315 |
) |
Total liabilities, convertible
preferred stock and stockholders’ equity (deficit) |
|
$ |
411,854 |
|
|
$ |
36,516 |
|
|
|
|
|
|
|
|
|
|
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