Applied Therapeutics Reports First Quarter 2021 Financial Results
11 Maggio 2021 - 1:00PM
Applied Therapeutics, Inc. (Nasdaq: APLT) (“Applied Therapeutics”
or the “Company”), a clinical-stage biopharmaceutical company
developing a pipeline of novel drug candidates against validated
molecular targets in indications of high unmet medical need, today
reported financial results for the first quarter ended March 31,
2021.
“In the first quarter we continued to progress
our late stage programs towards commercialization in Galactosemia
and Diabetic Cardiomyopathy, while advancing our additional rare
disease programs in SORD and PMM2-CDG,” said Shoshana Shendelman,
PhD, Founder, CEO and Chair of the Board of Applied Therapeutics.
“We are looking forward to our planned NDA submission in
Galactosemia in the third quarter of this year, and continue to
focus on our primary objective – bringing drugs to patients in
desperate need of treatment.”
Recent Highlights
-
Initiated Phase 2 Study of AT-007 in Patients with SORD
Deficiency. The Phase 2 pilot study of AT-007 in patients
with Sorbitol Dehydrogenase Deficiency (SORD Deficiency), a
progressive, debilitating hereditary neuropathy that affects
peripheral nerves and motor neurons, has been initiated.
Preclinical findings demonstrate that AT-007 has the potential to
be the first disease-modifying therapy for SORD, targeting the
underlying cause of disease.
-
Presented Data on Galactosemia Disease Progression at the
2021 Annual Clinical Genetics Meeting of the American College of
Medical Genetics and Genomics. In April 2021, the Company
presented data featuring a cross-sectional analysis of nineteen
pediatric patients with Classic Galactosemia, providing meaningful
insight on the progressive worsening of the central nervous system
phenotype with age.
- Hosted
Virtual Rare Disease Forum. In March 2021, the Company
hosted a virtual forum highlighting its AT-007 development programs
in Galactosemia, SORD Deficiency, and PMM2-CDG. A replay of the
presentation, which featured several rare disease key opinion
leaders, is available at
https://www.appliedtherapeutics.com/presentations-and-publications/.
- Announced Restart of
Pediatric Galactosemia Study. In February 2021, the
Company announced that the FDA lifted the clinical hold on the
AT-007 ACTION-Galactosemia Kids pediatric clinical study, and the
study resumed immediately. Applied Therapeutics worked closely with
FDA to modify the trial, with the shared goal of ensuring that all
patients have the opportunity to receive clinical benefit, and
remains on target to submit an NDA no later than Q3 2021.
- Closed Approximately $75
million Public Offering. In February 2021, the Company
completed an underwritten public offering of 3,450,000 shares of
its common stock, including the exercise in full of the
underwriters’ option to purchase 450,000 additional shares of
common stock at a price of $23.00 per share, resulting in
aggregate net proceeds of approximately $74.4 million.
Financial Results
- Cash and cash equivalents
and short-term investments totaled $148.1 million as of
March 31, 2021, compared with $96.8 million at December 31,
2020.
- Research and development
expenses for the three months ended March 31, 2021 were
$14.4 million, compared to $7.3 million for the three months ended
March 31, 2020. The increase of $7.2 million was primarily related
to an increase in clinical and pre-clinical expense of $1.3
million, related to the progression of the AT-007
ACTION-Galactosemia adult extension study, the AT-007
ACTION-Galactosemia Kids pediatric registrational study and the
AT-001 Phase 3 ARISE-HF clinical study; an increase in drug
manufacturing and formulation costs of $5.2 million related to the
progression of the manufacturing campaigns and the completion and
release of AT-001 and AT-007 drug product batches; an increase in
personnel expenses of $0.3 million due to the increase in headcount
in support of our clinical program pipeline; an increase in
stock-based compensation of $0.2 million due to new stock option
and restricted stock unit grants; and an increase in regulatory and
other expenses of $0.2 million relating to an increase in clinical
consulting fees during the three months ended March 31, 2021.
- General and administrative
expenses were $9.8 million for the three months ended
March 31, 2021, compared to $5.2 million for the three months ended
March 31, 2020. The increase of approximately $4.6 million was
primarily related to an increase of $1.9 million related to the
establishment of a commercial department; an increase in
stock-based compensation of $1.5 million and increase in personnel
expenses of $0.9 million related to an increase in headcount; an
increase of $0.2 million related to increased insurance costs; an
increase of $0.4 million in other expenses relating to increased
costs of rent and other office expenses; and a $0.4 million
decrease in legal and professional fees due to lower external legal
fees.
- Net loss for the
first quarter of 2021 was $24.2 million, or $1.00 per basic and
diluted common share, compared to a net loss of $12.4 million, or
$0.59 per basic and diluted common share, for the first quarter
2020.
About Applied Therapeutics
Applied Therapeutics is a clinical-stage
biopharmaceutical company developing a pipeline of novel drug
candidates against validated molecular targets in indications of
high unmet medical need. The Company’s lead drug candidate, AT-007,
is a novel central nervous system penetrant aldose reductase
inhibitor (ARI) for the treatment of Galactosemia, a rare pediatric
metabolic disease. The Company initiated a pivotal Phase 1/2
clinical trial in June 2019, read out positive top-line biomarker
data in adult Galactosemia patients in January 2020 and announced
full data from the trial in April 2020. A pediatric Galactosemia
study commenced in June 2020. The Company is also developing
AT-001, a novel potent ARI that is being developed for the
treatment of Diabetic Cardiomyopathy, or DbCM, a fatal fibrosis of
the heart. The Company initiated a Phase 3 registrational study in
DbCM in September 2019. The preclinical pipeline also includes
AT-003, an ARI designed to cross through the back of the eye when
dosed orally, for the treatment of diabetic retinopathy, as well as
novel dual PI3k inhibitors in preclinical development for orphan
oncology indications.
Forward-Looking Statements
This press release contains “forward-looking
statements” that involve substantial risks and uncertainties for
purposes of the safe harbor provided by the Private Securities
Litigation Reform Act of 1995. Any statements, other than
statements of historical fact, included in this press release
regarding strategy, future operations, prospects, plans and
objectives of management, including words such as “may,” “will,”
“expect,” “anticipate,” “plan,” “intend,” and similar expressions
(as well as other words or expressions referencing future events,
conditions or circumstances) are forward-looking statements. These
include, without limitation, statements regarding (i) the timing of
our NDA submission for potential approval of AT-007, which will
include data from the ACTION-Galactosemia Kids trial and the 90-day
safety data in adults with Galactosemia, (ii) the timing of our
rare disease franchise expansion programs in SORD Deficiency and
PMM2-CDG, (iii) the timing of the initiation and completion of our
clinical trials, (iv) the likelihood that data from our clinical
trials will support future development of our product candidates
and (v) the likelihood of obtaining regulatory approval of our
product candidates. Forward-looking statements in this release
involve substantial risks and uncertainties that could cause actual
results to differ materially from those expressed or implied by the
forward-looking statements, and we, therefore cannot assure you
that our plans, intentions, expectations or strategies will be
attained or achieved.
Such risks and uncertainties include, without
limitation, (i) our plans to develop and commercialize our product
candidates, (ii) the initiation, timing, progress and results of
our current and future preclinical studies and clinical trials and
our research and development programs, (iii) our ability to take
advantage of expedited regulatory pathways for any of our product
candidates, (iv) our estimates regarding expenses, future revenue,
capital requirements and needs for additional financing, (v) our
ability to successfully acquire or license additional product
candidates on reasonable terms, (vi) our ability to maintain and
establish collaborations or obtain additional funding, (vii) our
ability to obtain regulatory approval of our current and future
product candidates, (viii) our expectations regarding the potential
market size and the rate and degree of market acceptance of such
product candidates, (ix) our ability to fund our working capital
requirements and expectations regarding the sufficiency of our
capital resources, (x) the implementation of our business model and
strategic plans for our business and product candidates, (xi) our
intellectual property position and the duration of our patent
rights, (xii) developments or disputes concerning our intellectual
property or other proprietary rights, (xiii) our expectations
regarding government and third-party payor coverage and
reimbursement, (xiv) our ability to compete in the markets we
serve, (xv) the impact of government laws and regulations and
liabilities thereunder, (xvi) developments relating to our
competitors and our industry, (xvii) the impact of the COVID-19
pandemic on the timing and progress of our ongoing clinical trials
and our business in general and (xviii) other factors that may
impact our financial results. In light of the significant
uncertainties in these forward-looking statements, you should not
rely upon forward-looking statements as predictions of future
events. Although we believe that we have a reasonable basis for
each forward-looking statement contained in this press release, we
cannot guarantee that the future results, levels of activity,
performance or events and circumstances reflected in the
forward-looking statements will be achieved or occur at all.
Factors that may cause actual results to differ from those
expressed or implied in the forward-looking statements in this
press release are discussed in our filings with the U.S. Securities
and Exchange Commission, including the “Risk Factors” contained
therein. Except as otherwise required by law, we disclaim any
intention or obligation to update or revise any forward-looking
statements, which speak only as of the date they were made, whether
as a result of new information, future events or circumstances or
otherwise.
Contacts
Investors:Maghan Meyers or Brendan Burns(212)
600-1902 orappliedtherapeutics@argotpartners.com
Media:media@appliedtherapeutics.com
Applied Therapeutics,
Inc.Statement of Operations(in
thousands, except share and per share
data)(Unaudited)
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
|
2021 |
|
|
2020 |
|
|
OPERATING EXPENSES: |
|
|
|
|
|
|
|
Research and development |
|
$ |
14,448 |
|
|
$ |
7,271 |
|
|
General and administrative |
|
|
9,751 |
|
|
|
5,196 |
|
|
Total operating expenses |
|
|
24,199 |
|
|
|
12,467 |
|
|
LOSS FROM OPERATIONS |
|
|
(24,199 |
) |
|
|
(12,467 |
) |
|
OTHER INCOME (EXPENSE),
NET: |
|
|
|
|
|
|
|
Interest income (expense), net |
|
|
76 |
|
|
|
122 |
|
|
Other income (expense) |
|
|
(56 |
) |
|
|
(24 |
) |
|
Total other income (expense), net |
|
|
20 |
|
|
|
98 |
|
|
Net loss |
|
$ |
(24,179 |
) |
|
$ |
(12,369 |
) |
|
Net loss attributable to
common stockholders—basic and diluted |
|
$ |
(24,179 |
) |
|
$ |
(12,369 |
) |
|
Net loss per share
attributable to common stockholders—basic and diluted |
|
$ |
(1.00 |
) |
|
$ |
(0.59 |
) |
|
Weighted-average common stock
outstanding—basic and diluted |
|
|
24,135,735 |
|
|
|
20,840,658 |
|
|
|
|
|
|
|
|
|
|
|
|
Applied Therapeutics,
Inc.Balance Sheet(in thousands,
except share and per share data)
|
|
|
|
|
|
|
|
|
|
As of |
|
As of |
|
|
|
March 31, |
|
December 31, |
|
|
|
2021 |
|
|
2020 |
|
|
|
|
(Unaudited) |
|
|
|
ASSETS |
|
|
|
|
|
|
|
CURRENT ASSETS: |
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
84,067 |
|
|
$ |
57,466 |
|
|
Investments |
|
|
63,992 |
|
|
|
39,363 |
|
|
Prepaid expenses and other current assets |
|
|
6,347 |
|
|
|
5,764 |
|
|
Total current assets |
|
|
154,406 |
|
|
|
102,593 |
|
|
Operating lease right-of-use asset |
|
|
1,612 |
|
|
|
1,712 |
|
|
Security deposits and leasehold improvements |
|
|
201 |
|
|
|
201 |
|
|
TOTAL ASSETS |
|
$ |
156,219 |
|
|
$ |
104,506 |
|
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
CURRENT LIABILITIES: |
|
|
|
|
|
|
|
Current portion of operating lease liabilities |
|
$ |
415 |
|
|
$ |
406 |
|
|
Accounts payable |
|
|
3,475 |
|
|
|
640 |
|
|
Accrued expenses and other current liabilities |
|
|
15,884 |
|
|
|
20,189 |
|
|
Total current liabilities |
|
|
19,774 |
|
|
|
21,235 |
|
|
NONCURRENT LIABILITIES: |
|
|
|
|
|
|
|
Noncurrent portion of operating lease liabilities |
|
|
1,224 |
|
|
|
1,332 |
|
|
Total noncurrent liabilities |
|
|
1,224 |
|
|
|
1,332 |
|
|
Total liabilities |
|
|
20,998 |
|
|
|
22,567 |
|
|
STOCKHOLDERS’ EQUITY: |
|
|
|
|
|
|
|
Common stock, $0.0001 par value; 100,000,000 shares authorized as
of March 31, 2021 and December 31, 2020;
26,010,465 shares and 22,493,661 shares issued and outstanding as
of March 31, 2021 and December 31, 2020,
respectively |
|
|
3 |
|
|
|
2 |
|
|
Additional paid-in capital |
|
|
320,282 |
|
|
|
242,780 |
|
|
Accumulated other comprehensive loss |
|
|
(154 |
) |
|
|
(112 |
) |
|
Accumulated deficit |
|
|
(184,910 |
) |
|
|
(160,731 |
) |
|
Total stockholders' equity |
|
|
135,221 |
|
|
|
81,939 |
|
|
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
$ |
156,219 |
|
|
$ |
104,506 |
|
|
|
|
|
|
|
|
|
|
|
|
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