Applied Therapeutics Reports First Quarter 2022 Financial Results
12 Maggio 2022 - 12:59PM
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
first quarter ended March 31, 2022.
“We made significant progress in the first
quarter across all three of our Phase 3 programs,” said Shoshana
Shendelman, PhD, Founder and CEO of Applied Therapeutics. “We are
pleased to have reached alignment with the FDA on Galactosemia, and
are excited about the expected milestones in the year ahead.”
Recent Highlights
- Provided Regulatory Update
on Galactosemia Program. In January 2022, the Company
announced that the FDA would require clinical outcomes data for
approval. Clinical outcomes are assessed in the pediatric clinical
study every 6 months by a firewalled committee until the study
reaches statistical significance. The Company met with the FDA in
April 2022, and the FDA confirmed that the pediatric study as it is
currently designed would support an NDA submission if statistical
significance is reached. The 6-month clinical outcomes were
assessed by the firewalled data monitoring committee, and it was
determined that the safety/benefit profile supports
continuing the study. The next committee evaluation will
be following completion of the 12-month clinical outcomes
assessments.
- Presented Data on AT-007
Treatment in SORD Deficiency at the 2022 Annual Meeting of the
Peripheral Nerve Society. In May 2022, the Company
presented data highlighting the effect of AT-007 treatment on
sorbitol levels. In a pilot study in patients with Sorbitol
Dehydrogenase (SORD) Deficiency, sorbitol level correlated with
disease severity, and AT-007 treatment substantially reduced
sorbitol levels. In a Drosophila model of disease, elevated
sorbitol resulted in neuronal damage and decline in mobility, and
AT-007 treatment prevented the disease phenotype by inhibiting
sorbitol production. Taken together, this data significantly
advances the understanding of the disease and potential for
treatment with AT-007.
- Presented Data on
Galactosemia Disease Progression at the 2022 43rd Annual Meeting of
the Society for Inherited Metabolic Disorders. In April
2022, the Company presented data featuring baseline disease
characteristics of 47 pediatric patients with Classic Galactosemia,
illustrating the high burden of disease associated with
Galactosemia, including neurological complications, due to high
galactitol levels. In addition, data presented at the meeting
illustrated that higher galactitol levels, but not higher Gal-1p
levels, were associated with greater disease severity overall and
on each of the four quadrants of central nervous system (CNS)
function. Together, these data underscore the urgent need to bring
a treatment to people living with Galactosemia.
- Presented Data on
Galactosemia Disease Progression at the 2022 Annual Clinical
Genetics Meeting of the American College of Medical Genetics and
Genomics. In March 2022, the Company presented data
featuring the first therapeutic interventional clinical trial in
pediatric patients with Classic Galactosemia, demonstrating that
AT-007 significantly reduces toxic galactitol in
ACTION-Galactosemia children.
Financial Results
- Cash and cash equivalents
and short-term investments totaled $55.7 million as of
March 31, 2022, compared with $80.8 million at December 31,
2021.
- Research and development
expenses for the three months ended March 31, 2022 were
$15.0 million, compared to $14.4 million for the three months ended
March 31, 2021. The increase of $0.6 million was primarily due to
an increase in clinical and pre-clinical expense of $5.1 million,
primarily related to the progression of the SORD pivotal trial,
progression of the AT-007 ACTION-Galactosemia long-term extension
adult study, and progression of the AT-007 ACTION-Galactosemia Kids
pediatric registrational study; an increase in personnel expenses
of $0.8 million due to the increase in headcount in support of our
clinical program pipeline; an increase in regulatory and other
expenses of $0.2 million; an increase in stock-based compensation
of $0.1 million due to new stock option and restricted stock
grants; and offset by a decrease in drug manufacturing and
formulation costs of $5.6 million primarily related to the
completion and release of AT-001 and AT-007 drug product batches in
the three months ended March 31, 2021.
- General and administrative
expenses were $8.1 million for the three months ended
March 31, 2022, compared to $9.8 million for the three months ended
March 31, 2021. The decrease of $1.7 million was due to a decrease
in commercial expenses of $0.6 million related to a decrease in
spend relating to commercial operations; a decrease in other
expenses of $0.3 million relating to decreased costs of other
office expenses; a decrease in stock-based compensation of $1.0
million relating to options being forfeited during the current
period; a decrease in legal and professional fees of $0.2 million
due to lower external legal fees; offset by an increase in
personnel expenses of $0.2 million related to an increase in
headcount; and an increase in insurance expenses of $0.1 million
related to increased insurance costs.
- Net loss for the
first quarter of 2022 was $23.1 million, or $0.88 per basic and
diluted common share, compared to a net loss of $24.2 million, or
$1.00 per basic and diluted common share, for the first 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, as well as novel dual PI3k
inhibitors in preclinical development for orphan oncology
indications.
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.
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, 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.Statement of Operations(in thousands,
except share and per share data)
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
March 31, |
|
|
2022 |
|
|
2021 |
|
OPERATING EXPENSES: |
|
|
|
|
|
|
Research and development |
|
$ |
15,030 |
|
|
$ |
14,448 |
|
General and administrative |
|
|
8,071 |
|
|
|
9,751 |
|
Total operating expenses |
|
|
23,101 |
|
|
|
24,199 |
|
LOSS FROM OPERATIONS |
|
|
(23,101 |
) |
|
|
(24,199 |
) |
OTHER INCOME (EXPENSE),
NET: |
|
|
|
|
|
|
Interest income (expense), net |
|
|
76 |
|
|
|
76 |
|
Other income (expense) |
|
|
(96 |
) |
|
|
(56 |
) |
Total other income (expense), net |
|
|
(20 |
) |
|
|
20 |
|
Net loss |
|
$ |
(23,121 |
) |
|
$ |
(24,179 |
) |
Net loss attributable to
common stockholders—basic and diluted |
|
$ |
(23,121 |
) |
|
$ |
(24,179 |
) |
Net loss per share
attributable to common stockholders—basic and diluted |
|
$ |
(0.88 |
) |
|
$ |
(1.00 |
) |
Weighted-average common stock
outstanding—basic and diluted |
|
|
26,215,514 |
|
|
|
24,135,735 |
|
Applied Therapeutics,
Inc.Balance Sheet(in thousands, except
share and per share data)
|
|
As of |
|
As of |
|
|
March 31, |
|
December 31, |
|
|
2022 |
|
2021 |
|
|
(Unaudited) |
|
|
|
|
|
|
|
|
|
ASSETS |
|
|
|
|
|
|
CURRENT ASSETS: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
38,214 |
|
|
$ |
53,888 |
|
Investments |
|
|
17,437 |
|
|
|
26,935 |
|
Prepaid expenses and other current assets |
|
|
7,913 |
|
|
|
7,571 |
|
Total current assets |
|
|
63,564 |
|
|
|
88,394 |
|
Operating lease right-of-use asset |
|
|
1,190 |
|
|
|
1,298 |
|
Security deposits and leasehold improvements |
|
|
199 |
|
|
|
200 |
|
TOTAL ASSETS |
|
$ |
64,953 |
|
|
$ |
89,892 |
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
CURRENT LIABILITIES: |
|
|
|
|
|
|
Current portion of operating lease liabilities |
|
$ |
453 |
|
|
$ |
442 |
|
Accounts payable |
|
|
5,922 |
|
|
|
9,461 |
|
Accrued expenses and other current liabilities |
|
|
15,842 |
|
|
|
16,559 |
|
Total current liabilities |
|
|
22,217 |
|
|
|
26,462 |
|
NONCURRENT LIABILITIES: |
|
|
|
|
|
|
Noncurrent portion of operating lease liabilities |
|
|
773 |
|
|
|
891 |
|
Total noncurrent liabilities |
|
|
773 |
|
|
|
891 |
|
Total liabilities |
|
|
22,990 |
|
|
|
27,353 |
|
STOCKHOLDERS’ EQUITY: |
|
|
|
|
|
|
Common stock, $0.0001 par value; 100,000,000 shares authorized as
of March 31, 2022 and December 31, 2021;
26,215,514 shares issued and outstanding as of
March 31, 2022 and December 31, 2021 |
|
|
3 |
|
|
|
3 |
|
Preferred stock, par value $0.0001; 10,000,000 shares authorized as
of March 31, 2022 and December 31, 2021; 0 shares issued and
outstanding as of March 31, 2022 and December 31, 2021 |
|
|
- |
|
|
|
- |
|
Additional paid-in capital |
|
|
331,476 |
|
|
|
328,958 |
|
Accumulated other comprehensive loss |
|
|
(80 |
) |
|
|
(107 |
) |
Accumulated deficit |
|
|
(289,436 |
) |
|
|
(266,315 |
) |
Total stockholders' equity |
|
|
41,963 |
|
|
|
62,539 |
|
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
$ |
64,953 |
|
|
$ |
89,892 |
|
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