Full Press Release Details
Applied Therapeutics Reports Second Quarter
2022 Financial Results
Completed public equity offering with gross
proceeds of $30 million
Granted orphan medicinal product designation
by the EMA for AT-007 for treatment of Galactosemia
Continued progress in three registrational Phase
3 trials in areas of high unmet medical need, with multiple clinical milestones expected in 2H 2022, including Galactosemia 12 month data
analysis, SORD Deficiency biomarker data, and DbCM full enrollment
NEW YORK, August 12,
2022 - Applied Therapeutics, Inc. (NASDAQ: APLT) (the "Company"), 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, 2022.
"In the second quarter we continued our
progress across our three registrational Phase 3 trials in Galactosemia, SORD Deficiency and Diabetic Cardiomyopathy," said Shoshana
Shendelman, PhD, Founder, CEO and Chair of the Board of Applied Therapeutics. "As we look towards the second half of this year,
we are excited about the milestones ahead. We expect to complete our 12 month analysis in the pediatric Galactosemia study in September,
and plan to announce full enrollment in both SORD Deficiency and DbCM soon. We expect these catalysts to bring us closer to our goal of
delivering meaningful new treatments to patients in need."
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.
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,"
including, but not limited to, 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. 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, 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.
Condensed Balance Sheets
(in thousands, except share and per share data)
| As of | As of | |||||||
| June 30, | December 31, | |||||||
| 2022 | 2021 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 55,728 | $ | 53,888 | ||||
| Investments | 11,994 | 26,935 | ||||||
| Prepaid expenses and other current assets | 9,176 | 7,571 | ||||||
| Total current assets | 76,898 | 88,394 | ||||||
| Operating lease right-of-use asset | 1,081 | 1,298 | ||||||
| Security deposits and leasehold improvements | 199 | 200 | ||||||
| TOTAL ASSETS | $ | 78,178 | $ | 89,892 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Current portion of operating lease liabilities | $ | 462 | $ | 442 | ||||
| Accounts payable | 8,691 | 9,461 | ||||||
| Accrued expenses and other current liabilities | 17,787 | 16,559 | ||||||
| Warrant liability | 24,775 | - | ||||||
| Total current liabilities | 51,715 | 26,462 | ||||||
| NONCURRENT LIABILITIES: | ||||||||
| Noncurrent portion of operating lease liabilities | 655 | 891 | ||||||
| Total noncurrent liabilities | 655 | 891 | ||||||
| Total liabilities | 52,370 | 27,353 | ||||||
| STOCKHOLDERS' EQUITY: | ||||||||
| Common stock, $0.0001 par value; 100,000,000 shares authorized as of June 30, 2022 and December 31, 2021; 46,253,524 shares issued and outstanding as of June 30, 2022 and 26,215,514 shares issued and outstanding as of December 31, 2021 | 5 | 3 | ||||||
| Preferred stock, par value $0.0001; 10,000,000 shares authorized as of June 30, 2022 and December 31, 2021; 0 shares issued and outstanding as of June 30, 2022 and December 31, 2021 | - | - | ||||||
| Additional paid-in capital | 341,090 | 328,958 | ||||||
| Accumulated other comprehensive gain/(loss) | 6 | (107 | ) | |||||
| Accumulated deficit | (315,293 | ) | (266,315 | ) | ||||
| Total stockholders' equity | 25,808 | 62,539 | ||||||
| TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ | 78,178 | $ | 89,892 |
Applied Therapeutics, Inc.
Condensed Statements of Operations
(in thousands, except share and per share data)
| Three Months Ended | Six Months Ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| OPERATING EXPENSES: | ||||||||||||||||
| Research and development | $ | 15,396 | $ | 14,802 | $ | 30,426 | $ | 29,250 | ||||||||
| General and administrative | 6,125 | 11,073 | 14,196 | 20,824 | ||||||||||||
| Total operating expenses | 21,521 | 25,875 | 44,622 | 50,074 | ||||||||||||
| LOSS FROM OPERATIONS | (21,521 | ) | (25,875 | ) | (44,622 | ) | (50,074 | ) | ||||||||
| OTHER INCOME (EXPENSE), NET: | ||||||||||||||||
| Interest income | 111 | 169 | 187 | 245 | ||||||||||||
| Change in fair value of warrant liabilities | (4,357 | ) | - | (4,357 | ) | - | ||||||||||
| Other expense | (90 | ) | (122 | ) | (186 | ) | (178 | ) | ||||||||
| Total other income (expense), net | (4,336 | ) | 47 | (4,356 | ) | 67 | ||||||||||
| Net loss | $ | (25,857 | ) | $ | (25,828 | ) | $ | (48,978 | ) | $ | (50,007 | ) | ||||
| Net loss attributable to common stockholders-basic and diluted | $ | (25,857 | ) | $ | (25,828 | ) | $ | (48,978 | ) | $ | (50,007 | ) | ||||
| Net loss per share attributable to common stockholders-basic and diluted | $ | (0.96 | ) | $ | (0.99 | ) | $ | (1.84 | ) | $ | (1.99 | ) | ||||
| Weighted-average common stock outstanding-basic and diluted | 26,901,069 | 26,082,525 | 26,560,185 | 25,114,508 |