Applied Therapeutics Reports Third Quarter 2022 Financial Results
09 November 2022 - 11:00PM
Applied Therapeutics, Inc. (NASDAQ: APLT) (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 third quarter ended September 30, 2022.
“In the third quarter, we made significant
progress across all three of our late-stage programs,” said
Shoshana Shendelman, PhD, Founder, CEO and Chair of the Board of
Applied Therapeutics. “We remain focused on successful completion
of our ongoing Phase 3 trials in Galactosemia, SORD Deficiency and
Diabetic Cardiomyopathy, and look forward to sharing data in 2023,
with the potential to bring new treatment options to these patients
with limited to no available therapies.”
Recent Highlights
- Presented
Data on AT-001 Treatment in Diabetic Cardiomyopathy at the 2022
American Heart Association Scientific Sessions. In
November 2022, the Company presented data in multiple sessions
featuring mechanistic support for AT-001, a selective Aldose
Reductase inhibitor, in a Diabetic Cardiomyopathy (DbCM) mouse
model, demonstrating that AT-001 treatment prevents fibrosis and
adverse cardiac remodeling, baseline data from the ongoing Phase 3
ARISE-HF study on quality of life impact of disease and correlation
of cardiac functional capacity (peak VO2) with physical function
and additional DbCM diagnosis and prevalence data.
- Announced
Full Enrollment in the Registrational Phase 3 ARISE-HF Trial of
AT-001 in Diabetic Cardiomyopathy. In October 2022, the
Company announced full enrollment in the Phase 3 registrational
ARISE-HF trial studying AT-001 in patients with DbCM. The primary
endpoint is cardiac functional capacity (as measured by Peak VO2)
at 15 months of treatment. The Company continues to expect topline
data around year-end 2023 or early 2024, and if positive, the
Company plans to submit for potential regulatory approval. Patients
will continue in blinded format for an additional 12 months of
treatment (up to 27 months total) to produce secondary endpoint
data on progression to overt heart failure, hospitalization,
morbidity and mortality, which is not anticipated to be required
for regulatory approval, but will support long-term market
access.
- Reported
Positive Data Trend in AT-007 ACTION-Galactosemia Kids Pediatric
Trial. In October 2022, the Company announced that the
ACTION-Galactosemia Kids Phase 3 trial demonstrated a trend in
clinical benefit favoring AT-007 vs. placebo. Review of the data at
12 months of treatment by the DMC indicated that while the study
primary endpoint has not yet reached statistical significance, a
trend exists favoring AT-007 vs. placebo. The clinical benefit at
this early time point was most pronounced in patients with
significant deficits in clinical performance at baseline. Safety
data demonstrated that AT-007 continues to be safe and well
tolerated. The study will continue to proceed in blinded format to
the next review at 18 months of treatment. In the meantime, the
Company will meet with the EMA to discuss potential submission of
an MAA based on existing data for conditional approval.
Financial Results
- Cash and
cash equivalents and short-term investments totaled $47.4
million as of September 30, 2022, compared with $80.8 million at
December 31, 2021.
-
Research and development expenses for the three
months ended September 30, 2022 were $13.1 million, compared to
$17.6 million for the three months ended September 30, 2021. The
decrease of $4.5 million was primarily related to a decrease in
drug manufacturing and formulation costs of $2.9 million related to
the completion and release of AT-007 drug product batches and
purchase of raw materials in the three months ended September 30,
2021; a decrease in clinical and pre-clinical expense of $1.7
million, primarily due to reduced clinical trial spend on the
AT-007 ACTION-Galactosemia Kids pediatric registrational study and
AT-007 ACTION-Galactosemia long-term extension adult study; and a
decrease in regulatory and other expenses of $0.4 million. This was
partially offset by an increase in personnel expenses of $48,000
due to the increase in headcount in support of our clinical program
pipeline; and an increase in stock-based compensation of $0.5
million due to new stock option and restricted stock units grants
and due to the incremental stock-based compensation expense
recognized as a result of the stock option repricing.
-
General and administrative expenses were $6.2
million for the three months ended September 30, 2022, compared to
$10.8 million for the three months ended September 30, 2021. The
decrease of $4.6 million was primarily due to a decrease in legal
and professional fees of $0.2 million due to lower external legal
fees; a decrease in commercial expenses of $2.8 million related to
a decrease in spend for commercial operations; a decrease in
personnel expenses of $0.5 million related to a decrease in
headcount; a decrease in stock-based compensation of $0.3 million
relating to options being forfeited during the current period; a
decrease in insurance expenses of $0.3 million related to decreased
insurance costs; and a decrease in other expenses of $0.5 million
relating to decreased costs of other office expenses.
- Net
loss for the third quarter of 2022 was $19.1 million, or
$0.40 per basic and diluted common share, compared to a net loss of
$28.4 million, or $1.09 per basic and diluted common share, for the
third quarter 2021.
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 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 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 topline
data, which is expected around year-end 2023 or early 2024, (ii)
the company’s plans to submit for potential regulatory approval and
(iii) the company’s plans to meet with the EMA to discuss
conditional 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)
the impact of the COVID-19 pandemic on the timing and progress of
our ongoing clinical trials and our business in general 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@appliedtherapeutics.com
Applied
Therapeutics, Inc.Condensed Balance
Sheets(in thousands, except share and per share
data)
|
|
|
|
|
|
|
As of |
|
As of |
|
September 30, |
|
December 31, |
|
2022 |
|
|
2021 |
|
|
(Unaudited) |
|
|
|
|
|
|
|
|
ASSETS |
|
|
|
|
|
CURRENT ASSETS: |
|
|
|
|
|
Cash and cash equivalents |
$ |
40,388 |
|
|
$ |
53,888 |
|
Investments |
|
6,990 |
|
|
|
26,935 |
|
Prepaid expenses and other current assets |
|
8,132 |
|
|
|
7,571 |
|
Total current assets |
|
55,510 |
|
|
|
88,394 |
|
Operating lease right-of-use asset |
|
970 |
|
|
|
1,298 |
|
Security deposits and leasehold improvements |
|
199 |
|
|
|
200 |
|
TOTAL ASSETS |
$ |
56,679 |
|
|
$ |
89,892 |
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
CURRENT LIABILITIES: |
|
|
|
|
|
Current portion of operating lease liabilities |
$ |
470 |
|
|
$ |
442 |
|
Accounts payable |
|
6,973 |
|
|
|
9,461 |
|
Accrued expenses and other current liabilities |
|
14,332 |
|
|
|
16,559 |
|
Warrant liability |
|
24,739 |
|
|
|
— |
|
Total current liabilities |
|
46,514 |
|
|
|
26,462 |
|
NONCURRENT LIABILITIES: |
|
|
|
|
|
Noncurrent portion of operating lease liabilities |
|
536 |
|
|
|
891 |
|
Total noncurrent liabilities |
|
536 |
|
|
|
891 |
|
Total liabilities |
|
47,050 |
|
|
|
27,353 |
|
STOCKHOLDERS’ EQUITY: |
|
|
|
|
|
Common stock, $0.0001 par value; 100,000,000 shares authorized as
of September 30, 2022 and December 31, 2021;
48,058,956 shares issued and outstanding as of
September 30, 2022 and 26,215,514 shares issued and
outstanding as of December 31, 2021 |
|
5 |
|
|
|
3 |
|
Preferred stock, par value $0.0001; 10,000,000 shares authorized as
of September 30, 2022 and December 31, 2021; 0 shares issued and
outstanding as of September 30, 2022 and December 31, 2021 |
|
- |
|
|
|
- |
|
Additional paid-in capital |
|
343,995 |
|
|
|
328,958 |
|
Accumulated other comprehensive gain/(loss) |
|
23 |
|
|
|
(107 |
) |
Accumulated deficit |
|
(334,394 |
) |
|
|
(266,315 |
) |
Total stockholders' equity |
|
9,629 |
|
|
|
62,539 |
|
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY |
$ |
56,679 |
|
|
$ |
89,892 |
|
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, |
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
OPERATING EXPENSES: |
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
13,116 |
|
|
$ |
17,597 |
|
|
$ |
43,542 |
|
|
$ |
46,846 |
|
General and administrative |
|
6,240 |
|
|
|
10,833 |
|
|
|
20,436 |
|
|
|
31,658 |
|
Total operating expenses |
|
19,356 |
|
|
|
28,430 |
|
|
|
63,978 |
|
|
|
78,504 |
|
LOSS FROM OPERATIONS |
|
(19,356 |
) |
|
|
(28,430 |
) |
|
|
(63,978 |
) |
|
|
(78,504 |
) |
OTHER INCOME (EXPENSE),
NET: |
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
227 |
|
|
|
76 |
|
|
|
414 |
|
|
|
321 |
|
Change in fair value of warrant liabilities |
|
36 |
|
|
|
— |
|
|
|
(4,321 |
) |
|
|
— |
|
Other expense |
|
(8 |
) |
|
|
(64 |
) |
|
|
(194 |
) |
|
|
(242 |
) |
Total other income (expense), net |
|
255 |
|
|
|
12 |
|
|
|
(4,101 |
) |
|
|
79 |
|
Net loss |
$ |
(19,101 |
) |
|
$ |
(28,418 |
) |
|
$ |
(68,079 |
) |
|
$ |
(78,425 |
) |
Net loss attributable to
common stockholders—basic and diluted |
$ |
(19,101 |
) |
|
$ |
(28,418 |
) |
|
$ |
(68,079 |
) |
|
$ |
(78,425 |
) |
Net loss per share
attributable to common stockholders—basic and diluted |
$ |
(0.40 |
) |
|
$ |
(1.09 |
) |
|
$ |
(2.02 |
) |
|
$ |
(3.08 |
) |
Weighted-average common stock
outstanding—basic and diluted |
|
48,000,183 |
|
|
|
26,177,079 |
|
|
|
33,785,386 |
|
|
|
25,472,590 |
|
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