Full Press Release Details
Applied Therapeutics Reports First Quarter
2022 Financial Results
Continued progress in three Phase 3 trials
in areas of high unmet medical need, with multiple clinical
milestones expected in 2022
2022 - 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."
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) our
NDA submission for potential approval of AT-007, (ii) the timing of the completion of our the statistical analysis of clinical outcomes,
(iii) the timing of expected milestones, (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
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.
(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 |