Applied Therapeutics Reports First Quarter 2019 Financial Results
21 Giugno 2019 - 1:00PM
Applied Therapeutics, Inc. (Nasdaq: APLT), a clinical-stage
biopharmaceutical company developing novel drug candidates in
indications of high unmet medical need, today reported financial
results for the first quarter ended March 31, 2019.
“Since the launch of Applied Therapeutics just
three years ago, we have built a robust pipeline of novel drug
candidates with the potential to deliver a meaningful impact in
multiple disease areas of high unmet medical need,” said Shoshana
Shendelman, PhD, President and Chief Executive Officer of Applied
Therapeutics. “With the recent completion of our initial public
offering, we have strengthened our cash position, extending our
runway and providing additional resources to accelerate our
clinical development plan. This includes our lead asset, AT-001,
which is on track to enter a pivotal Phase 2/3 clinical trial in
diabetic cardiomyopathy (DbCM) later this year and advance AT-007
into Phase 1/2 study into adults with Galactosemia this month.”
Recent Highlights
- Received FDA Orphan Drug Designation for AT-007 in
Galactosemia. In May 2019, we received orphan drug
designation for AT-007 in Galactosemia. The designation
allows Applied Therapeutics to qualify for a number of
incentives, including: seven years of market exclusivity upon
regulatory approval, if received; exemption
from FDA application fees for Galactosemia; and tax
credits for qualified clinical trials.
- Presented Phase 1/2 Data Highlighting Safety and
Efficacy for AT-001 in DbCM at the American Diabetes Association
(ADA) 79th Annual Scientific Sessions in San Francisco. In
June 2019, we presented Phase 1/2 Data Highlighting Safety and
Efficacy for AT-001 in DbCM at the ADA Annual Scientific Sessions.
The data, presented as part of the Late Breaking session,
demonstrated that AT-001 was well tolerated at all dose levels, and
target engagement was confirmed by potent aldose reductase (AR)
inhibition as evidenced by significant reductions in sorbitol, a
pharmacodynamic biomarker of AR activity. AT-001 also improved
selectivity and affinity for AR and resulted in potent AR
inhibition.
- Presented Phase 1/2 Data Highlighting Safety and Proof
of Biological Activity for AT-001 in DbCM at The European Society
for Cardiology (ESC) 6th World Congress in Athens, Greece.
In May 2019, we presented two posters at ESC, the first of which
was presented in the Late Breaking session and highlighted
key data from a recently completed Phase 1/2 study in approximately
120 type 2 diabetic patients demonstrating the safety and proof of
biological activity for AT-001 in DbCM. Supporting preclinical data
from an animal model of DbCM was also presented, demonstrating that
AT-001 prevents or reduces cardiac damage in a relevant disease
model.
- Completed Initial Public Offering. In May
2019, we completed our IPO, generating approximately $34.0 million
in net proceeds, after deducting underwriting discounts and
commissions and estimated offering expenses payable by us.
- Announced Appointment of Mark Vignola, PhD, as Chief
Financial Officer. In April 2019, we announced the
appointment of Mark Vignola, PhD, as Chief Financial Officer. Dr.
Vignola served most recently as Head of Corporate Development &
Investor Relations at Intercept Pharmaceuticals.
Financial Results
- Cash and cash equivalents totaled $14.7
million as of March 31, 2019, compared with $18.7 million at
December 31, 2018. Subsequent to the close of the quarter, we
completed an initial public offering resulting in net proceeds of
approximately $34.0 million.
- Research and development expenses for the
three months ended March 31, 2019 were $6.9 million, compared
to $1.5 million for the three months ended March 31, 2018. The
increase of approximately $5.4 million was primarily related to the
progressing of our clinical trials through development, including
an increase in clinical and pre‑clinical expenses of $4.1 million
and drug manufacturing and formulation expenses of $0.7 million,
and personnel expenses of $0.7 million due to the hiring of
research and development personnel, including the Chief Medical
Officer in August 2018.
- General and administrative expenses were $1.9
million for the three months ended March 31, 2019, compared to
$0.4 million for the three months ended March 31, 2018. The
increase of approximately $1.4 million was primarily related to
professional fees of $0.7 million due to increased legal and
consulting fees, personnel expenses of $0.4 million due to the
hiring of other personnel, including the interim Chief Financial
Officer and the Controller, and other expenses of $0.3 million,
primarily due to public relations efforts, travel expenses and
rent.
- Net loss for the first quarter of 2019 was
$8.7 million, or $1.58 per basic and diluted common share, compared
to a net loss of $2.3 million, or $.43 per basic and diluted common
share, for the first quarter of 2018.
About Applied Therapeutics Inc.
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 product candidate,
AT-001, is a novel aldose reductase inhibitor (ARI) that is being
developed for the treatment of Diabetic Cardiomyopathy, or DbCM, a
fatal fibrosis of the heart. The company plans to initiate a
Phase 2/3 pivotal study in DbCM in 2019. Applied Therapeutics
is also developing AT-007, a central nervous system penetrant ARI,
for the treatment of Galactosemia, a rare pediatric metabolic
disease, which is expected to advance into a Phase 1 clinical trial
in 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, expected to
advance into Phase 1 in 2020. For more information, visit
www.appliedtherapeutics.com.
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 the (i) our cash
runway and acceleration of our clinical development plan, (ii) the
likelihood data will support future development of our product
candidates, (iii) qualification for exemptions resulting from the
receipt of orphan drug designation and (iii) the expected timing of
the initiation of our clinical trials. 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, the uncertainties
inherent in the initiation, execution and completion of clinical
trials, in the timing of availability of trial data, in the results
of the clinical trials, in the actions of regulatory agencies, in
the commercialization and acceptance of new therapies. 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.
Investors:Maeve
Conneighton(212) 600-1902
orappliedtherapeutics@argotpartners.com
Media:
media@appliedtherapeutics.com
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Applied Therapeutics,
Inc. |
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Condensed Statements of
Operations |
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(in
thousands, except share and per share
data) |
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(Unaudited) |
Three Months Ended March 31, |
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2019 |
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2018 |
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OPERATING
EXPENSES: |
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|
|
Research and
development |
$ |
6,874 |
|
|
$ |
1,448 |
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General and
administrative |
|
1,855 |
|
|
$ |
420 |
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Total operating expenses |
|
8,729 |
|
|
$ |
1,868 |
|
LOSS FROM
OPERATIONS |
|
(8,729 |
) |
|
$ |
(1,868 |
) |
OTHER INCOME
(EXPENSE), NET: |
|
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Interest income
(expense), net |
|
(1 |
) |
|
$ |
(281 |
) |
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Other expense |
|
|
- |
|
|
$ |
(186 |
) |
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Total other income
(expense), net |
|
(1 |
) |
|
$ |
(467 |
) |
Net
loss |
$ |
(8,730 |
) |
|
$ |
(2,335 |
) |
Net loss
attributable to common stockholders—basic and diluted |
$ |
(8,730 |
) |
|
$ |
(2,335 |
) |
Net loss per share
attributable to common stockholders—basic and diluted |
$ |
(1.58 |
) |
|
$ |
(0.43 |
) |
Weighted-average
common stock outstanding—basic and diluted |
|
5,513,531 |
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5,458,450 |
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Applied
Therapeutics, Inc. |
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Condensed
Balance Sheets |
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(in
thousands, except share and per share data) |
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As of March 31, |
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As of December 31, |
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2019 |
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2018 |
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(Unaudited) |
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ASSETS |
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CURRENT
ASSETS: |
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Cash and cash
equivalents |
$ |
14,686 |
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|
$ |
18,748 |
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Prepaid expenses
and other current assets |
|
2,186 |
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|
1,498 |
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Total current assets |
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16,872 |
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20,246 |
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TOTAL ASSETS |
$ |
16,872 |
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$ |
20,246 |
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LIABILITIES, CONVERTIBLE PREFERRED STOCK
AND STOCKHOLDERS’ DEFICIT |
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CURRENT
LIABILITIES: |
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Accounts
payable |
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2,649 |
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|
3,015 |
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Accrued expenses
and other current liabilities |
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3,679 |
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1,413 |
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Total current liabilities |
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6,328 |
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|
4,428 |
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Total liabilities |
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6,328 |
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4,428 |
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Series A
convertible preferred stock, $0.0001 par value; 3,093,898
shares |
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authorized at
March 31, 2019 and December 31, 2018; |
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3,093,898 shares
issued and outstanding at March 31, 2019 |
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and December 31,
2018; liquidation preference |
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of $7,000 at March
31, 2019 and December 31, 2018; |
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6,254 |
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6,254 |
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Series B
convertible preferred stock, $0.0001 par value; 7,790,052 |
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shares authorized
as of March 31, 2019 and December 31, 2018; |
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4,444,773 and
4,001,848 shares issued and outstanding as of |
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March 31, 2019 and
December 31, 2018, respectively; |
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liquidation
preference of $33,281 and $29,964 as of |
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March 31, 2019 and
December 31, 2018, respectively; |
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32,207 |
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|
29,156 |
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STOCKHOLDERS’
DEFICIT: |
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Common stock,
$0.0001 par value; 20,441,982 shares authorized as of |
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March 31, 2019 and
December 31, 2018; 5,513,531 shares issued |
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and outstanding as
of March 31, 2019 and December 31, 2018 |
|
- |
|
|
|
- |
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Additional paid-in
capital |
|
2,070 |
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|
|
1,665 |
|
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Accumulated
deficit |
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(29,987 |
) |
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(21,257 |
) |
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Total stockholders'
deficit |
|
(27,917 |
) |
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(19,592 |
) |
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TOTAL LIABILITIES, CONVERTIBLE
PREFERRED STOCK AND STOCKHOLDERS’ DEFICIT |
$ |
16,872 |
|
|
$ |
20,246 |
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