Full Press Release Details
Therapeutics Reports Second Quarter 2020 Financial Results
August 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 second quarter ended June 30, 2020.
"The second quarter was an exciting
time for the Company, as we continued to advance our late stage programs towards regulatory submission and commercial launch,"
said Shoshana Shendelman, PhD, Founder, CEO and Chair of the Board of Applied Therapeutics. "As we move through the rest
of the year, we remain focused on our commitment to bringing drugs to patients in urgent need of treatment across multiple diseases,
which we believe will ultimately drive shareholder value."
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 pivotal Phase 1/2
clinical trial in June 2019, read out positive top-line biomarker data in adult Galactosemia patients in January 2020
and announced full data from the trial in April 2020. A pediatric Galactosemia study commenced in June 2020 and is currently
ongoing. 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, as well as novel dual PI3k inhibitors in preclinical development for orphan oncology indications.
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 plans to submit an NDA for potential approval of AT-007 around year-end 2020, which
will also include data from the ACTION-Galactosemia Kids trial and the 90-day safety data in adults with Galactosemia, (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.
Statements of Operations
(in thousands, except share and per
| Three Months Ended | Six Months Ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||||
| OPERATING EXPENSES: | ||||||||||||||||
| Research and development | $ | 20,758 | $ | 4,254 | $ | 28,028 | $ | 11,128 | ||||||||
| General and administrative | 7,522 | 4,183 | 12,725 | 6,037 | ||||||||||||
| Total operating expenses | 28,280 | 8,437 | 40,753 | 17,165 | ||||||||||||
| LOSS FROM OPERATIONS | (28,280 | ) | (8,437 | ) | (40,753 | ) | (17,165 | ) | ||||||||
| OTHER INCOME (EXPENSE), NET: | ||||||||||||||||
| Interest income (expense), net | 183 | - | 304 | (1 | ) | |||||||||||
| Other income (expense) | 38 | - | 21 | - | ||||||||||||
| Total other income (expense), net | 221 | - | 325 | (1 | ) | |||||||||||
| Net loss | $ | (28,059 | ) | $ | (8,437 | ) | $ | (40,428 | ) | $ | (17,166 | ) | ||||
| Net loss attributable to common stockholders-basic and diluted | $ | (28,059 | ) | $ | (8,437 | ) | $ | (40,428 | ) | $ | (17,166 | ) | ||||
| Net loss per share attributable to common stockholders-basic and diluted | $ | (1.27 | ) | $ | (0.60 | ) | $ | (1.88 | ) | $ | (1.76 | ) | ||||
| Weighted-average common stock outstanding-basic and diluted | 22,062,030 | 13,945,939 | 21,451,344 | 9,776,582 |
Applied Therapeutics, Inc.
(in thousands, except share and per share
| As of | As of | |||||||
| June 30, | December 31, | |||||||
| 2020 | 2019 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 100,854 | $ | 18,850 | ||||
| Investments | 37,644 | 20,004 | ||||||
| Prepaid expenses and other current assets | 10,026 | 7,301 | ||||||
| Total current assets | 148,524 | 46,155 | ||||||
| Operating lease right-of-use asset | 1,849 | 2,035 | ||||||
| Security deposits and leasehold improvements | 199 | 199 | ||||||
| TOTAL ASSETS | $ | 150,572 | $ | 48,389 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT) | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Current portion of operating lease liabilities | 372 | 356 | ||||||
| Accounts payable | 5,649 | 8,793 | ||||||
| Accrued expenses and other current liabilities | 12,855 | 4,950 | ||||||
| Total current liabilities | 18,876 | 14,099 | ||||||
| NONCURRENT LIABILITIES: | ||||||||
| Noncurrent portion of operating lease liabilities | 1,492 | 1,683 | ||||||
| Total noncurrent liabilities | 1,492 | 1,683 | ||||||
| Total liabilities | 20,368 | 15,782 | ||||||
| STOCKHOLDERS' EQUITY: | ||||||||
| Common stock, $0.0001 par value; 100,000,000 and 100,000,000 shares authorized as of June 30, 2020 and December 31, 2019, respectively; 22,331,142 shares and 18,531,560 shares issued and outstanding as of June 30, 2020 and December 31, 2019, respectively | 2 | 1 | ||||||
| Additional paid-in capital | 237,429 | 99,378 | ||||||
| Accumulated other comprehensive loss | (29 | ) | (2 | ) | ||||
| Accumulated deficit | (107,198 | ) | (66,770 | ) | ||||
| Total stockholders' equity | 130,204 | 32,607 | ||||||
| TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ | 150,572 | $ | 48,389 |