Full Press Release Details
Applied Therapeutics Reports Second Quarter
2021 Financial Results
NDA submission for AT-007 in Galactosemia expected
in Q3 2021; commercial preparations ongoing
Ended Q2 2021 with a strong balance sheet with
$125.6 million in cash and cash equivalents and short-term investments
NEW YORK, August 12,
2021 - 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."
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.
Applied Therapeutics, Inc.
Statement of Operations
(in thousands, except share and per share data)
| 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.
(in thousands, except share and per share data)
| As of | As of | |||||||
| June 30, | December 31, | |||||||
| 2021 | 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 |