Applied Therapeutics Reports Third Quarter 2019 Financial Results
13 Novembre 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 third quarter ended September 30, 2019.
“The third quarter was a critical period of
progress at Applied, and we are extremely pleased to have met all
of our objectives,” said Shoshana Shendelman, PhD, Founder, Chief
Executive Officer and Chair of the Board of Applied
Therapeutics. “We are now in the final phase of development
on both of our lead programs, having initiated our Phase 3
registrational study of AT-001 in Diabetic Cardiomyopathy
(ARISE-HF) and transitioned into the Phase 2 portion of our
Galactosemia trial (ACTION-Galactosemia) in the third
quarter. We continue to maintain our momentum and remain on
track to report pivotal data on our Galactosemia program by year
end. Recently, we had an opportunity to broaden our
shareholder base and strengthen the balance sheet through a private
placement, providing us with additional cash runway as we move
beyond development and into commercialization of our lead
assets.”
Recent Highlights
- Closed $20M Private
Placement. In November 2019, we announced the close of a
private placement of common stock, resulting in gross proceeds of
approximately $20 million.
- Presented Data Highlighting
AT-007 for the Treatment of Galactosemia at the ASHG Annual
Meeting. In October 2019, our Chief Medical Officer,
Riccardo Perfetti, MD, PhD, gave an oral platform presentation
highlighting AT-007 for the treatment of Galactosemia at the
American Society of Human Genetics (ASHG) 2019 Annual Meeting in
Houston. We also hosted an Educational Symposium featuring a panel
of Galactosemia experts.
- Presented Preclinical and
Clinical Data on AT-001 in Diabetic Cardiomyopathy (DbCM) at the
EASD and HFSA Annual Meetings. In September 2019, we presented
preclinical and clinical proof of concept data on AT-001 in
DbCM at the Heart Failure Society of America (HFSA) 23rd
Annual Scientific Meeting in Philadelphia. In addition, we
presented a preclinical poster on AT-001 at the 55th Annual Meeting
of the European Association for the Study of Diabetes (EASD) in
Barcelona, demonstrating that AT-001 significantly reduces cardiac
damage in an animal model of DbCM. These data further support the
development rationale and clinical proof of concept for AT-001 in
DbCM.
- Initiated Phase 3
Registrational Trial of AT-001 in Diabetic Cardiomyopathy
(ARISE-HF). In September 2019, we announced the initiation
of ARISE-HF, a Phase 3 registrational trial for AT-001 in Diabetic
Cardiomyopathy (DbCM). ARISE-HF is a double-blind, placebo
controlled, Phase 3 registrational trial expected to enroll
approximately 675 type 2 diabetic patients with DbCM at high risk
of progression to overt heart failure. ARISE-HF will assess
AT-001’s ability to improve or prevent decline in exercise
tolerance as measured by peak VO2 over 15 months of
treatment. Additional supportive secondary and exploratory
endpoints include percent of patients progressing to overt heart
failure, quality of life metrics (modified KCCQ), echocardiographic
measurements and cardiac stress biomarkers, including
NTproBNP. At the conclusion of the core trial, patients may
continue into a 12-month placebo-controlled extension study to
assess potential impact on cardiovascular death and
hospitalization.
- Reported Single and
Multiple Ascending Dose Data from Healthy Volunteer Portion of
Phase 1/2 ACTION-Galactosemia Trial Evaluating AT-007. In
August 2019, we announced the completion of the Single Ascending
Dose healthy volunteer portion of the Phase 1/2 study of AT-007 in
Galactosemia. In October, at the ASHG meeting, we provided an
update on Multiple Ascending Dose portion of the study. AT-007 was
well tolerated, with no drug-related adverse events or
dose-limiting toxicities reported. The study, referred to as
ACTION-Galactosemia, was initiated in June 2019 and is designed to
investigate the safety and pharmacokinetics (PK) of AT-007, a
central nervous system (CNS) penetrant Aldose Reductase (AR)
inhibitor in healthy volunteers, and biomarker effects in adult
subjects with Galactosemia. Data from the adult Galactosemia
patient portion of the trial is expected in the fourth quarter of
2019. We plan to employ recent FDA guidance permitting
biomarker-based development in low prevalence, slowly progressing
rare metabolic diseases, such as Galactosemia.
Financial Results
- Cash and cash equivalents
and short-term investments totaled $33.0 million as of
September 30, 2019, compared with $18.8 million at December 31,
2018. Subsequent to the close of the quarter, we closed a
private placement of common stock resulting in net proceeds of
approximately $20 million.
- Research and development
expenses for the three months ended September 30, 2019
were $7.5 million, compared to $2.7 million for the three months
ended September 30, 2018. The increase of approximately $4.8
million was primarily related to the progressing of our clinical
trials through development, including an increase in clinical and
pre-clinical expenses of $4.0 million and personnel expenses of
$1.0 million due to the hiring of research and development
personnel, including the Chief Medical Officer in August 2018.
These increases are offset by a decrease in drug manufacturing and
formulation expenses of $0.1 million and decrease in regulatory and
other expenses of $0.1 million.
- General and administrative
expenses were $3.3 million for the three months ended
September 30, 2019, compared to $0.6 million for the three months
ended September 30, 2018. The increase of approximately $2.7
million was primarily related to personnel expenses of $1.0 million
due to the increase in headcount, including the hiring of the Chief
Financial Officer, professional fees of $0.9 million due to
increased legal and consulting fees, and other expenses of $0.8
million, primarily due to public relations efforts, travel expenses
and recruiting efforts.
- Net loss for the
third quarter of 2019 was $10.7 million, or $0.63 per basic and
diluted common share, compared to a net loss of $4.3 million, or
$0.78 per basic and diluted common share, for the third 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 drug 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 initiated a Phase 3
registrational study in DbCM in September 2019. Applied
Therapeutics is also developing AT-007, a central nervous system
penetrant ARI, for the treatment of Galactosemia, a rare pediatric
metabolic disease, and initiated a Phase 1/2 clinical trial in June
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
a Phase 1 study in 2020.
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 design,
scope and results of our clinical trials, (ii) the timing of the
initiation and completion of our clinical trials, (iii) the
likelihood that data from our clinical trials will support future
development of our product candidates, (iv) the likelihood of
obtaining regulatory approval of our product candidates and
qualifying for any special designations, such as orphan drug
designation, (v) our cash runway and the timing of our clinical
development plan. 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
Applied Therapeutics, Inc. Statement of
Operations
|
Three Months Ended |
|
Nine Months Ended |
|
September 30, |
|
September 30, |
|
2019 |
|
2018 |
|
2019 |
|
2018 |
OPERATING EXPENSES: |
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
7,453 |
|
|
$ |
2,726 |
|
|
$ |
18,582 |
|
|
$ |
6,111 |
|
General and administrative |
|
3,294 |
|
|
|
598 |
|
|
|
9,331 |
|
|
|
1,418 |
|
Total operating expenses |
|
10,747 |
|
|
|
3,324 |
|
|
|
27,913 |
|
|
|
7,529 |
|
LOSS FROM OPERATIONS |
|
(10,747 |
) |
|
|
(3,324 |
) |
|
|
(27,913 |
) |
|
|
(7,529 |
) |
OTHER INCOME (EXPENSE),
NET: |
|
|
|
|
|
|
|
|
|
|
|
Interest income (expense), net |
|
34 |
|
|
|
(584 |
) |
|
|
33 |
|
|
|
(1,400 |
) |
Other expense |
|
— |
|
|
|
(373 |
) |
|
|
— |
|
|
|
(873 |
) |
Total other income (expense), net |
|
34 |
|
|
|
(957 |
) |
|
|
33 |
|
|
|
(2,273 |
) |
Net loss |
$ |
(10,713 |
) |
|
$ |
(4,281 |
) |
|
$ |
(27,880 |
) |
|
$ |
(9,802 |
) |
Net loss attributable to
common stockholders—basic and diluted |
$ |
(10,713 |
) |
|
$ |
(4,281 |
) |
|
$ |
(27,880 |
) |
|
$ |
(9,802 |
) |
Net loss per share
attributable to common stockholders—basic and diluted |
$ |
(0.63 |
) |
|
$ |
(0.78 |
) |
|
$ |
(1.98 |
) |
|
$ |
(1.79 |
) |
Weighted-average common stock
outstanding—basic and diluted |
|
17,095,870 |
|
|
|
5,497,871 |
|
|
|
14,085,579 |
|
|
|
5,473,414 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Applied Therapeutics, Inc.Balance
Sheet
|
|
As of |
|
As of |
|
|
September 30, |
|
December 31, |
|
|
2019 |
|
2018 |
|
|
(Unaudited) |
|
|
|
ASSETS |
|
|
|
|
|
|
CURRENT ASSETS: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
13,065 |
|
|
$ |
18,748 |
|
Prepaid expenses and other current assets |
|
|
4,080 |
|
|
|
1,498 |
|
Investments |
|
|
19,889 |
|
|
|
— |
|
Total current assets |
|
|
37,034 |
|
|
|
20,246 |
|
Other assets |
|
|
230 |
|
|
|
— |
|
TOTAL ASSETS |
|
$ |
37,264 |
|
|
$ |
20,246 |
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY (DEFICIT) |
|
|
|
|
|
|
CURRENT LIABILITIES: |
|
|
|
|
|
|
Accounts payable |
|
|
1,688 |
|
|
|
3,015 |
|
Accrued expenses and other current liabilities |
|
|
4,829 |
|
|
|
1,413 |
|
Total current liabilities |
|
|
6,517 |
|
|
|
4,428 |
|
Total liabilities |
|
|
6,517 |
|
|
|
4,428 |
|
|
|
|
|
|
|
|
Series A convertible
preferred stock, $0.0001 par value; 0 shares and 3,093,898 shares
authorized at September 30, 2019 and
December 31, 2018, respectively; 0 shares and 3,093,898
shares issued and outstanding at September 30, 2019 and
December 31, 2018, respectively; liquidation preference
of $0 and $7,000 at September 30, 2019 and
December 31, 2018, respectively |
|
|
— |
|
|
|
6,254 |
|
Series B convertible
preferred stock, $0.0001 par value; 0 shares and 7,790,052 shares
authorized as of September 30, 2019 and
December 31, 2018, respectively; 0 shares
and 4,001,848 shares issued and outstanding as of
September 30, 2019 and December 31, 2018,
respectively; liquidation preference of $0 and $29,964 as of
September 30, 2019 and December 31, 2018,
respectively |
|
|
— |
|
|
|
29,156 |
|
|
|
|
|
|
|
|
STOCKHOLDERS’ EQUITY
(DEFICIT): |
|
|
|
|
|
|
Common stock, $0.0001 par value; 100,000,000 and 20,441,982 shares
authorized as of September 30, 2019 and
December 31, 2018, respectively; 17,134,190 shares and
5,513,531 shares issued and outstanding as of
September 30, 2019 and December 31, 2018,
respectively |
|
|
1 |
|
|
|
— |
|
Additional paid-in capital |
|
|
79,872 |
|
|
|
1,665 |
|
Accumulated other comprehensive loss |
|
|
11 |
|
|
|
— |
|
Accumulated deficit |
|
|
(49,137 |
) |
|
|
(21,257 |
) |
Total stockholders' equity (deficit) |
|
|
30,747 |
|
|
|
(19,592 |
) |
TOTAL LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’
EQUITY (DEFICIT) |
|
$ |
37,264 |
|
|
$ |
20,246 |
|
|
|
|
|
|
|
|
|
|
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