Recent Updates
Recently added Catalysts
APLT

Applied Therapeutics Reports First Quarter 2020 Financial Results

Key Takeaway: Applied Therapeutics Reports First Quarter 2020 Financial Results NEW YORK, May 11, 2020 - Applied Therapeutics, Inc. (Nasdaq: APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications o

Full Press Release Details

Applied Therapeutics Reports First Quarter
2020 Financial Results
NEW YORK, May 11, 2020 - 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
"The first quarter was a period of
tremendous growth and advancement across our clinical programs," said Shoshana Shendelman, PhD, Founder, CEO and Chair of
the Board of Applied Therapeutics. "We also began building out our commercial infrastructure in preparation for future
launches, including Galactosemia. The company remains well capitalized as a result of the financing in January, and we look
forward to continuing our momentum throughout the rest of this year - launching our pediatric study in Galactosemia, continuing
enrollment on the DbCM ARISE-HF study, and advancing additional new programs forward into the clinic."
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 Galactosemia, a rare pediatric metabolic disease. The Company initiated a Phase 1/2 clinical
trial in June 2019 and read out positive top-line biomarker data in adult Galactosemia patients in January of 2020. The Company
is also developing AT-001, a novel potent 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. 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, as well as novel dual PI3k inhibitors in preclinical development for orphan oncology
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) our plan to move quickly towards regulatory filing following our pivotal Phase 2 ACTION-Galactosemia
study, while preparing for Galactosemia commercial launch and growing our organization, (ii) the design, scope and results of our
clinical trials, (iii) the timing of the initiation and completion of our clinical trials, (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 and qualifying for any special designations, such as orphan drug designation. 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.
Applied Therapeutics, Inc.
Statement of Operations
(in thousands, except share and per share
Three Months Ended
March 31,
2020 2019
OPERATING EXPENSES:
Research and development $ 7,271 $ 6,874
General and administrative 5,196 1,855
Total operating expenses 12,467 8,729
LOSS FROM OPERATIONS (12,467 ) (8,729 )
OTHER INCOME (EXPENSE), NET:
Interest income (expense), net 122 (1 )
Other income (expense) (24 ) -
Total other income (expense), net 98 (1 )
Net loss $ (12,369 ) $ (8,730 )
Net loss attributable to common stockholders-basic and diluted $ (12,369 ) $ (8,730 )
Net loss per share attributable to common stockholders-basic and diluted $ (0.59 ) $ (1.58 )
Weighted-average common stock outstanding-basic and diluted 20,840,658 5,513,531
Applied Therapeutics, Inc.
(in thousands, except share and per share
As of As of
March 31, December 31,
2020 2019
(Unaudited)
ASSETS
CURRENT ASSETS:
Cash and cash equivalents $ 92,503 $ 18,850
Prepaid expenses and other current assets 9,432 7,301
Investments 61,806 20,004
Total current assets 163,741 46,155
Operating lease right-of-use asset 1,942 2,035
Security deposits and leasehold improvements 199 199
TOTAL ASSETS $ 165,882 $ 48,389
LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)
CURRENT LIABILITIES:
Current portion of operating lease liabilities 364 356
Accounts payable 1,606 8,793
Accrued expenses and other current liabilities 6,496 4,950
Total current liabilities 8,466 14,099
NONCURRENT LIABILITIES:
Noncurrent portion of operating lease liabilities 1,588 1,683
Total noncurrent liabilities 1,588 1,683
Total liabilities 10,054 15,782
STOCKHOLDERS' EQUITY:
Common stock, $0.0001 par value; 100,000,000 and 100,000,000 shares authorized as of March 31, 2020 and December 31, 2019, respectively; 21,969,277 shares and 18,531,560 shares issued and outstanding as of March 31, 2020 and December 31, 2019, respectively 2 1
Additional paid-in capital 234,876 99,378
Accumulated other comprehensive loss 89 (2 )
Accumulated deficit (79,139 ) (66,770 )
Total stockholders' equity 155,828 32,607
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 165,882 $ 48,389
Last updated: May 11, 2020