Applied Therapeutics Reports Third Quarter 2023 Financial Results
09 Noviembre 2023 - 6:30AM
Applied Therapeutics, Inc. (Nasdaq: APLT), 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
third quarter ended September 30, 2023.
“We have continued to make progress across our late-stage
pipeline and have several key regulatory and clinical inflection
points expected later this quarter and in early 2024,” said
Shoshana Shendelman, PhD, Founder, Chief Executive Officer, and
Chair of the Board. “We are working expeditiously to submit our
regulatory filings for govorestat (AT-007) for the treatment of
Classic Galactosemia in both the U.S. and in Europe and look
forward to providing updates as those submissions occur. In tandem,
we are soon approaching Phase 3 readouts for our ARISE-HF Trial of
AT-001 (caficrestat) in Diabetic Cardiomyopathy (DbCM) and our
INSPIRE Trial of AT-007 trial in Sorbitol Dehydrogenase (SORD)
Deficiency, which are expected in 4Q23 and in 1Q24,
respectively.”
Recent Highlights
- On Track to Submit NDA to the U.S. FDA and MAA to the
EMA for Govorestat (AT-007) for the Treatment of Classic
Galactosemia in the Fourth Quarter of 2023. The Company is
working to submit a New Drug Application (NDA) to the United States
Food and Drug Administration (U.S. FDA) for govorestat for the
treatment of Galactosemia. As previously announced, the Company
held a successful pre-NDA meeting with the FDA regarding the
govorestat Galactosemia program. Based on discussions with the FDA,
the Company believes they are aligned with the FDA and plans to
submit an NDA for govorestat (AT-007) for the treatment of
Galactosemia in the fourth quarter of this year. Regarding
regulatory submission plans in Europe, the Company and its European
commercial partner, Advanz Pharma, expect to submit a Marketing
Authorization Application (MAA) to the European Medicines Agency
(EMA) this quarter.
- Hosted an Expert Forum on Diabetic Cardiomyopathy with
Leading Cardiologists. In November 2023, the Company
hosted a KOL discussion on Diabetic Cardiomyopathy (DbCM) led by
James Januzzi, MD, Hutter Family Professor of Medicine, Harvard
Medical School, Director, Dennis and Marilyn Barry Fellowship in
Cardiology Research, Massachusetts General Hospital Gregory Lewis,
MD, Director, Cardiopulmonary Exercise Testing Laboratory and
Section Head, Heart Failure, Massachusetts General Hospital. The
ongoing ARISE-HF Phase 3 global clinical trial is evaluating the
safety and efficacy of AT-001 (caficrestat) in improving or
preventing worsening of cardiac functional capacity in Diabetic
Cardiomyopathy (DbCM). The Company expects topline data from the
study in the fourth quarter of 2023. A replay of the webcast event
can be accessed here.
- Presented Baseline Data from Ongoing Phase 3 ARISE-HF
Study of AT-001 (caficrestat) in Diabetic Cardiomyopathy at the
2023 European Association for the Study of Diabetes Annual
Meeting. In September 2023, the Company presented baseline
data at the 2023 European Association for the Study of Diabetes
(EASD) Annual Meeting from the ongoing Phase 3 ARISE-HF study of
AT-001 (caficrestat) in DbCM. Riccardo Perfetti, MD, PhD, Chief
Medical Officer of Applied Therapeutics, presented the data in an
oral Symposium entitled Diabetic Cardiomyopathy (DbCM): a severe
complication of diabetes. The baseline data presented at EASD
showed that patients with DbCM exhibit reduced cardiac functional
capacity, resulting in decreased physical capacity, underscoring
the negative impact of DbCM on physical function and quality of
life in patients. The data supports the development of AT-001 for
the treatment of DbCM and the ongoing ARISE-HF Phase 3 global
clinical trial.
Financial Results
- Cash and cash equivalents and short-term
investments totaled $37.5 million as of September 30,
2023, compared with $30.6 million at December 31, 2022.
- Research and development expenses for the
three months ended September 30, 2023 were $10.8 million, compared
to $13.1 million for the three months ended September 30, 2022. The
decrease of approximately $2.3 million was primarily related
to a decrease in clinical and pre-clinical expense of $1.8 million,
primarily due to the decrease in expense related to CROs, a
decrease in drug manufacturing and formulation costs of $0.5
million primarily due to the release of legacy accrual in the three
months ended September 30, 2023; an increase in personnel expenses
of $10,000; a decrease in stock-based compensation of $0.4 million
due to decrease in headcount which resulted in options and
restricted stock units being forfeited; and an increase in
regulatory and other expenses of $0.4 million.
- General and administrative expenses were $4.7
million for the three months ended September 30, 2023, compared to
$6.2 million for the three months ended September 30, 2022. The
decrease of approximately $1.5 million was primarily related
to an increase in legal and professional fees of $0.7 million due
to higher external legal fees; a decrease in commercial expenses of
$0.8 million related to a decrease in spend for commercial
operations and release of legacy accruals for the three months
ended September 30, 2023; a decrease in personnel expenses of $0.4
million related to a decrease in headcount; a decrease in
stock-based compensation of $0.6 million relating to options and
restricted stock units being forfeited during the current period as
well as decrease in headcount; a decrease in insurance expenses of
$0.4 million related to decreased insurance costs; and a decrease
in other expenses of $0.1 million.
- Net loss for the third quarter of 2023 was
$42.4 million, or $0.47 per basic and diluted common share,
compared to a net loss of $19.1 million, or $0.40 per basic and
diluted common share, for the third quarter 2022.
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, govorestat, is a novel
central nervous system penetrant Aldose Reductase Inhibitor (ARI)
for the treatment of CNS rare metabolic diseases, including
Galactosemia, SORD Deficiency, and PMM2-CDG. The Company is also
developing AT-001, a novel potent ARI, for the treatment of
Diabetic Cardiomyopathy, or DbCM, a fatal fibrosis of the heart.
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.
To learn more, please visit
www.appliedtherapeutics.com and follow the company on Twitter
@Applied_Tx.
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 the 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 data
readouts for our ARISE-HF and INSPIRE trials, (ii) the timing of
our plans to submit an NDA and MAA for approval. 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, market 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 and advance product candidates into,
and successfully complete, clinical studies, (vi) our ability to
maintain and establish collaborations or obtain additional funding,
(vii) our ability to obtain and timing of regulatory approval of
our current and future product candidates, (viii) the anticipated
indications for our product candidates, if approved, (ix) our
expectations regarding the potential market size and the rate and
degree of market acceptance of such product candidates, (x) our
ability to fund our working capital requirements and expectations
regarding the sufficiency of our capital resources, (xi) the
implementation of our business model and strategic plans for our
business and product candidates, (xii) our intellectual property
position and the duration of our patent rights, (xiii) developments
or disputes concerning our intellectual property or other
proprietary rights, (xiv) our expectations regarding government and
third-party payor coverage and reimbursement, (xv) our ability to
compete in the markets we serve, (xvi) the impact of government
laws and regulations and liabilities thereunder, (xvii)
developments relating to our competitors and our industry, (xvii)
our ability to achieve the anticipated benefits from the agreements
entered into in connection with our partnership with Advanz Pharma
and (xiv) 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:Maeve Conneighton (212) 600-1902
orappliedtherapeutics@argotpartners.com
Media:media@apliedtherapeutics.com
Applied Therapeutics, Inc. |
Condensed Balance Sheets |
(in thousands, except share and per share
data) |
|
|
|
As of |
|
As of |
|
|
September 30, |
|
December 31, |
|
|
2023 |
|
2022 |
|
|
(Unaudited) |
|
|
ASSETS |
|
|
|
|
|
|
CURRENT ASSETS: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
37,457 |
|
|
$ |
16,657 |
|
Investments |
|
|
— |
|
|
|
13,923 |
|
Prepaid expenses and other current assets |
|
|
7,031 |
|
|
|
6,728 |
|
Total current assets |
|
|
44,488 |
|
|
|
37,308 |
|
Operating lease right-of-use asset |
|
|
510 |
|
|
|
857 |
|
Security deposits and leasehold improvements |
|
|
197 |
|
|
|
198 |
|
TOTAL ASSETS |
|
$ |
45,195 |
|
|
$ |
38,363 |
|
LIABILITIES AND
STOCKHOLDERS’ (DEFICIT)/EQUITY |
|
|
|
|
|
|
CURRENT LIABILITIES: |
|
|
|
|
|
|
Current portion of operating lease liabilities |
|
$ |
491 |
|
|
$ |
477 |
|
Accounts payable |
|
|
6,005 |
|
|
|
4,534 |
|
Accrued expenses and other current liabilities |
|
|
12,245 |
|
|
|
14,756 |
|
Warrant liabilities |
|
|
36,763 |
|
|
|
13,657 |
|
Total current liabilities |
|
|
55,504 |
|
|
|
33,424 |
|
NONCURRENT LIABILITIES: |
|
|
|
|
|
|
Noncurrent portion of operating lease liabilities |
|
|
44 |
|
|
|
414 |
|
Clinical holdback - long-term portion |
|
|
691 |
|
|
|
464 |
|
Total noncurrent liabilities |
|
|
735 |
|
|
|
878 |
|
Total liabilities |
|
|
56,239 |
|
|
|
34,302 |
|
STOCKHOLDERS’
(DEFICIT)/EQUITY: |
|
|
|
|
|
|
Common stock, $0.0001 par value; 200,000,000 shares authorized as
of September 30, 2023 and December 31, 2022;
77,133,516 shares issued and outstanding as of
September 30, 2023 and 48,063,358 shares issued and
outstanding as of December 31, 2022 |
|
|
7 |
|
|
|
5 |
|
Preferred stock, par value $0.0001; 10,000,000 shares authorized as
of September 30, 2023 and December 31, 2022; 0
shares issued and outstanding as of September 30, 2023
and December 31, 2022 |
|
|
— |
|
|
|
— |
|
Additional paid-in capital |
|
|
419,856 |
|
|
|
352,828 |
|
Accumulated other comprehensive gain |
|
|
— |
|
|
|
51 |
|
Accumulated deficit |
|
|
(430,907 |
) |
|
|
(348,823 |
) |
Total stockholders' (deficit)/equity |
|
|
(11,044 |
) |
|
|
4,061 |
|
TOTAL LIABILITIES AND STOCKHOLDERS’ (DEFICIT)/EQUITY |
|
$ |
45,195 |
|
|
$ |
38,363 |
|
Applied Therapeutics, Inc. |
Condensed Statements of Operations |
(in thousands, except share and per share
data) |
(Unaudited) |
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
|
September 30, |
|
September 30, |
|
|
2023 |
|
2022 |
|
2023 |
|
2022 |
REVENUE: |
|
|
|
|
|
|
|
|
|
|
|
|
License Revenue |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
10,660 |
|
|
$ |
— |
|
Total Revenue |
|
|
— |
|
|
|
— |
|
|
|
10,660 |
|
|
|
— |
|
OPERATING EXPENSES: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
10,785 |
|
|
$ |
13,116 |
|
|
$ |
38,602 |
|
|
$ |
43,542 |
|
General and administrative |
|
|
4,710 |
|
|
|
6,240 |
|
|
|
15,585 |
|
|
|
20,436 |
|
Total operating expenses |
|
|
15,495 |
|
|
|
19,356 |
|
|
|
54,187 |
|
|
|
63,978 |
|
LOSS FROM OPERATIONS |
|
|
(15,495 |
) |
|
|
(19,356 |
) |
|
|
(43,527 |
) |
|
|
(63,978 |
) |
OTHER INCOME (EXPENSE),
NET: |
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
392 |
|
|
|
227 |
|
|
|
1,020 |
|
|
|
414 |
|
Change in fair value of warrant liabilities |
|
|
(27,277 |
) |
|
|
36 |
|
|
|
(39,611 |
) |
|
|
(4,321 |
) |
Other income (expense): |
|
|
10 |
|
|
|
(8 |
) |
|
|
34 |
|
|
|
(194 |
) |
Total other income (expense), net |
|
|
(26,875 |
) |
|
|
255 |
|
|
|
(38,557 |
) |
|
|
(4,101 |
) |
Net loss |
|
$ |
(42,370 |
) |
|
$ |
(19,101 |
) |
|
$ |
(82,084 |
) |
|
$ |
(68,079 |
) |
Net loss attributable to
common stockholders—basic and diluted |
|
$ |
(42,370 |
) |
|
$ |
(19,101 |
) |
|
$ |
(82,084 |
) |
|
$ |
(68,079 |
) |
Net loss per share
attributable to common stockholders—basic and diluted |
|
$ |
(0.47 |
) |
|
$ |
(0.40 |
) |
|
$ |
(1.09 |
) |
|
$ |
(2.02 |
) |
Weighted-average common stock
outstanding—basic and diluted |
|
|
90,669,969 |
|
|
|
48,000,183 |
|
|
|
75,482,234 |
|
|
|
33,785,386 |
|
Applied Therapeutics (NASDAQ:APLT)
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Applied Therapeutics (NASDAQ:APLT)
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