Applied Therapeutics Reports Second Quarter 2021 Financial Results
12 Agosto 2021 - 1:00PM
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
second quarter ended June 30, 2021.
“Our pediatric Galactosemia program advanced
significantly in the second quarter,” said Shoshana Shendelman,
PhD, CEO, Founder and Chair of the Board of Applied Therapeutics.
“We continue to prepare for our NDA submission in the third quarter
and our anticipated commercial launch in 2022. We are excited to
launch our registrational study in SORD and complete enrollment in
ARISE-HF, both of which are expected later this year.”
Recent Highlights
- Granted
Fast Track Designation by FDA for AT-007 for Galactosemia.
In June 2021, the U.S Food and Drug Administration (FDA) granted
Fast Track Designation to AT-007 for the treatment of Galactosemia.
Applied Therapeutics plans to submit a New Drug Application (NDA)
for Accelerated Approval of AT-007 for the treatment of
Galactosemia in the third quarter of this year. FDA had previously
granted Orphan Drug Designation and Pediatric Rare Disease status
to AT-007 for Galactosemia.
-
Presented Data on the Prevalence of Diabetic Cardiomyopathy
(DbCM) at the 81st Scientific
Sessions of the 2021 Annual Meeting of the American Diabetes
Association. In June 2021, the Company announced data
presentations confirming the high prevalence of DbCM in adults with
diabetes or pre-diabetes. The analysis estimated that ~ 1 in 5
people with diabetes or pre-diabetes have DbCM, a serious and
progressive disease that limits the heart’s ability to function.
The Phase 3 registrational ARISE-HF study evaluating AT-001 in
patients with DbCM continues to enroll.
- Added to
Russell Microcap® Index. In June 2021, the Company
announced that it had joined the Russell Microcap Index, effective
after the market close on Friday, June 25, 2021. Membership in the
Russell Microcap® Index, which remains in place for one year, means
automatic inclusion in the appropriate growth and value style
indexes. FTSE Russell determines membership for its Russell indexes
primarily by objective, market-capitalization rankings and style
attributes.
-
Presented Data on Galactosemia Disease Progression at the
2021 Annual Clinical Genetics Meeting of the American College of
Medical Genetics and Genomics. In April 2021, the Company
presented data featuring a cross-sectional analysis of nineteen
pediatric patients with Classic Galactosemia, providing meaningful
insight on the progressive worsening of the central nervous system
phenotype with age.
Financial Results
- Cash and cash equivalents
and short-term investments totaled $125.6 million as of
June 30, 2021, compared with $148.1 million at March 31, 2021.
- Research and development expenses for the
three months ended June 30, 2021 were $14.8 million, compared to
$20.8 million for the three months ended June 30, 2020. The
decrease of $6.0 million was related to a decrease in drug
manufacturing and formulation costs of $7.1 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; a
decrease in stock-based compensation of $0.1 million due to
forfeitures of stock option and restricted stock unit grants
related to personnel terminations; an increase in clinical and
pre-clinical expense of $0.9 million, primarily related to the
progression of the AT-007 ACTION-Galactosemia adult extension study
and the AT-007 ACTION-Galactosemia Kids pediatric registrational
study; and an increase in personnel expenses of $0.3 million due to
the increase in headcount in support of our clinical program
pipeline.
- General and administrative
expenses were $11.1 million for the three months ended
June 30, 2021, compared to $7.5 million for the three months ended
June 30, 2020. The increase of $3.6 million was primarily related
to an increase of $1.9 million related to the expansion of the
commercial department; an increase in stock-based compensation of
$1.1 million related to an increase in headcount; an increase of
$0.2 million related to increased insurance costs; an increase of
$0.9 million in other expenses related to increased costs of rent
and other office expenses; and a decrease of $0.4 million in legal
and professional fees due to lower external legal fees.
- Net loss for the
second quarter of 2021 was $25.8 million, or $0.99 per basic and
diluted common share, compared to a net loss of $28.1 million, or
$1.27 per basic and diluted common share, for the second quarter
2020.
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. These
include, without limitation, statements regarding (i) the timing of
our NDA submission for potential approval of AT-007, which will
include data from the ACTION-Galactosemia Kids trial and the 90-day
safety data in adults with Galactosemia, (ii) the timing of our
rare disease franchise expansion programs in SORD Deficiency, (iii)
the timing of the initiation and completion of our clinical trials,
including ARISE-HF, (iv) the likelihood that data from our clinical
trials will support future development of our product candidates
and (v) the likelihood of obtaining regulatory approval of our
product candidates. 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 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, (vi) our ability to maintain and
establish collaborations or obtain additional funding, (vii) our
ability to obtain regulatory approval of our current and future
product candidates, (viii) our expectations regarding the potential
market size and the rate and degree of market acceptance of such
product candidates, (ix) our ability to fund our working capital
requirements and expectations regarding the sufficiency of our
capital resources, (x) the implementation of our business model and
strategic plans for our business and product candidates, (xi) our
intellectual property position and the duration of our patent
rights, (xii) developments or disputes concerning our intellectual
property or other proprietary rights, (xiii) our expectations
regarding government and third-party payor coverage and
reimbursement, (xiv) our ability to compete in the markets we
serve, (xv) the impact of government laws and regulations and
liabilities thereunder, (xvi) 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 (xviii) 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:Maghan Meyers (212) 600-1902
orappliedtherapeutics@argotpartners.com
Media:media@appliedtherapeutics.com
Applied Therapeutics, Inc.
Statement of Operations(in thousands,
except share and per share
data)(Unaudited)
|
Three Months Ended |
|
Six Months Ended |
|
June 30, |
|
June 30, |
|
2021 |
|
2020 |
|
2021 |
|
2020 |
OPERATING EXPENSES: |
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
14,802 |
|
|
$ |
20,758 |
|
|
$ |
29,250 |
|
|
$ |
28,028 |
|
General and administrative |
|
11,073 |
|
|
|
7,522 |
|
|
|
20,824 |
|
|
|
12,725 |
|
Total operating expenses |
|
25,875 |
|
|
|
28,280 |
|
|
|
50,074 |
|
|
|
40,753 |
|
LOSS FROM OPERATIONS |
|
(25,875 |
) |
|
|
(28,280 |
) |
|
|
(50,074 |
) |
|
|
(40,753 |
) |
OTHER INCOME (EXPENSE),
NET: |
|
|
|
|
|
|
|
|
|
|
|
Interest income (expense), net |
|
169 |
|
|
|
183 |
|
|
|
245 |
|
|
|
304 |
|
Other income (expense) |
|
(122 |
) |
|
|
38 |
|
|
|
(178 |
) |
|
|
21 |
|
Total other income (expense), net |
|
47 |
|
|
|
221 |
|
|
|
67 |
|
|
|
325 |
|
Net loss |
$ |
(25,828 |
) |
|
$ |
(28,059 |
) |
|
$ |
(50,007 |
) |
|
$ |
(40,428 |
) |
Net loss attributable to
common stockholders—basic and diluted |
$ |
(25,828 |
) |
|
$ |
(28,059 |
) |
|
$ |
(50,007 |
) |
|
$ |
(40,428 |
) |
Net loss per share
attributable to common stockholders—basic and diluted |
$ |
(0.99 |
) |
|
$ |
(1.27 |
) |
|
$ |
(1.99 |
) |
|
$ |
(1.88 |
) |
Weighted-average common stock
outstanding—basic and diluted |
|
26,082,525 |
|
|
|
22,062,030 |
|
|
|
25,114,508 |
|
|
|
21,451,344 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Applied Therapeutics,
Inc.Balance Sheet(in thousands,
except share and per share data)
|
|
As ofJune 30,2021 |
|
As ofDecember 31,2020 |
|
|
(Unaudited) |
|
|
ASSETS |
|
|
|
|
|
|
CURRENT ASSETS: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
78,434 |
|
|
$ |
57,466 |
|
Investments |
|
|
47,182 |
|
|
|
39,363 |
|
Prepaid expenses and other current assets |
|
|
9,634 |
|
|
|
5,764 |
|
Total current assets |
|
|
135,250 |
|
|
|
102,593 |
|
Operating lease right-of-use asset |
|
|
1,508 |
|
|
|
1,712 |
|
Security deposits and leasehold improvements |
|
|
201 |
|
|
|
201 |
|
TOTAL ASSETS |
|
$ |
136,959 |
|
|
$ |
104,506 |
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
CURRENT LIABILITIES: |
|
|
|
|
|
|
Current portion of operating lease liabilities |
|
$ |
426 |
|
|
$ |
406 |
|
Accounts payable |
|
|
3,310 |
|
|
|
640 |
|
Accrued expenses and other current liabilities |
|
|
19,669 |
|
|
|
20,189 |
|
Total current liabilities |
|
|
23,405 |
|
|
|
21,235 |
|
NONCURRENT LIABILITIES: |
|
|
|
|
|
|
Noncurrent portion of operating lease liabilities |
|
|
1,114 |
|
|
|
1,332 |
|
Total noncurrent liabilities |
|
|
1,114 |
|
|
|
1,332 |
|
Total liabilities |
|
|
24,519 |
|
|
|
22,567 |
|
STOCKHOLDERS’ EQUITY: |
|
|
|
|
|
|
Common stock, $0.0001 par value; 100,000,000 shares authorized as
of June 30, 2021 and December 31, 2020;
26,130,536 shares and 22,493,661 shares issued and outstanding as
of June 30, 2021 and December 31, 2020,
respectively |
|
|
3 |
|
|
|
2 |
|
Additional paid-in capital |
|
|
323,360 |
|
|
|
242,780 |
|
Accumulated other comprehensive loss |
|
|
(185 |
) |
|
|
(112 |
) |
Accumulated deficit |
|
|
(210,738 |
) |
|
|
(160,731 |
) |
Total stockholders' equity |
|
|
112,440 |
|
|
|
81,939 |
|
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
$ |
136,959 |
|
|
$ |
104,506 |
|
|
|
|
|
|
|
|
|
|
Grafico Azioni Applied Therapeutics (NASDAQ:APLT)
Storico
Da Giu 2024 a Lug 2024
Grafico Azioni Applied Therapeutics (NASDAQ:APLT)
Storico
Da Lug 2023 a Lug 2024