Full Press Release Details
Applied Therapeutics Reports Third Quarter
2022 Financial Results
NEW YORK, November 9,
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 third quarter ended September 30, 2022.
the third quarter, we made significant progress across all three of our late-stage programs," said Shoshana Shendelman, PhD,
Founder, CEO and Chair of the Board of Applied Therapeutics. "We remain focused on successful completion of our ongoing Phase
3 trials in Galactosemia, SORD Deficiency and Diabetic Cardiomyopathy, and look forward to sharing data in 2023, with the potential to
bring new treatment options to these patients with limited to no available therapies."
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" 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 topline data, which is expected around year-end 2023 or early 2024, (ii) the company's plans to submit for potential
regulatory approval and (iii) the company's plans to meet with the EMA to discuss conditional approval. 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, market 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 and advance product candidates into, and successfully complete, clinical studies, (vi) our
ability to maintain and establish collaborations or obtain additional funding, (vii) our ability to obtain and timing of regulatory
approval of our current and future product candidates, (viii) the anticipated indications for our product candidates, if approved,
(ix) our expectations regarding the potential market size and the rate and degree of market acceptance of such product candidates,
(x) our ability to fund our working capital requirements and expectations regarding the sufficiency of our capital resources, (xi) the
implementation of our business model and strategic plans for our business and product candidates, (xii) our intellectual property
position and the duration of our patent rights, (xiii) developments or disputes concerning our intellectual property or other proprietary
rights, (xiv) our expectations regarding government and third-party payor coverage and reimbursement, (xv) our ability to compete
in the markets we serve, (xvi) the impact of government laws and regulations and liabilities thereunder, (xvii) 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 (xiv) 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.
Condensed Balance Sheets
(in thousands, except share and per share data)
| As of | ||||||||
| September 30, | As of | |||||||
| 2022 | December 31, | |||||||
| (Unaudited) | 2021 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 40,388 | $ | 53,888 | ||||
| Investments | 6,990 | 26,935 | ||||||
| Prepaid expenses and other current assets | 8,132 | 7,571 | ||||||
| Total current assets | 55,510 | 88,394 | ||||||
| Operating lease right-of-use asset | 970 | 1,298 | ||||||
| Security deposits and leasehold improvements | 199 | 200 | ||||||
| TOTAL ASSETS | $ | 56,679 | $ | 89,892 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Current portion of operating lease liabilities | $ | 470 | $ | 442 | ||||
| Accounts payable | 6,973 | 9,461 | ||||||
| Accrued expenses and other current liabilities | 14,332 | 16,559 | ||||||
| Warrant liability | 24,739 | - | ||||||
| Total current liabilities | 46,514 | 26,462 | ||||||
| NONCURRENT LIABILITIES: | ||||||||
| Noncurrent portion of operating lease liabilities | 536 | 891 | ||||||
| Total noncurrent liabilities | 536 | 891 | ||||||
| Total liabilities | 47,050 | 27,353 | ||||||
| STOCKHOLDERS' EQUITY: | ||||||||
| Common stock, $0.0001 par value; 100,000,000 shares authorized as of September 30, 2022 and December 31, 2021; 48,058,956 shares issued and outstanding as of September 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 September 30, 2022 and December 31, 2021; 0 shares issued and outstanding as of September 30, 2022 and December 31, 2021 | - | - | ||||||
| Additional paid-in capital | 343,995 | 328,958 | ||||||
| Accumulated other comprehensive gain/(loss) | 23 | (107 | ) | |||||
| Accumulated deficit | (334,394 | ) | (266,315 | ) | ||||
| Total stockholders' equity | 9,629 | 62,539 | ||||||
| TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ | 56,679 | $ | 89,892 |
Applied Therapeutics, Inc.
Condensed Statements of Operations
(in thousands, except share and per share data)
| Three Months Ended | Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| OPERATING EXPENSES: | ||||||||||||||||
| Research and development | $ | 13,116 | $ | 17,597 | $ | 43,542 | $ | 46,846 | ||||||||
| General and administrative | 6,240 | 10,833 | 20,436 | 31,658 | ||||||||||||
| Total operating expenses | 19,356 | 28,430 | 63,978 | 78,504 | ||||||||||||
| LOSS FROM OPERATIONS | (19,356 | ) | (28,430 | ) | (63,978 | ) | (78,504 | ) | ||||||||
| OTHER INCOME (EXPENSE), NET: | ||||||||||||||||
| Interest income | 227 | 76 | 414 | 321 | ||||||||||||
| Change in fair value of warrant liabilities | 36 | - | (4,321 | ) | - | |||||||||||
| Other expense | (8 | ) | (64 | ) | (194 | ) | (242 | ) | ||||||||
| Total other income (expense), net | 255 | 12 | (4,101 | ) | 79 | |||||||||||
| Net loss | $ | (19,101 | ) | $ | (28,418 | ) | $ | (68,079 | ) | $ | (78,425 | ) | ||||
| Net loss attributable to common stockholders-basic and diluted | $ | (19,101 | ) | $ | (28,418 | ) | $ | (68,079 | ) | $ | (78,425 | ) | ||||
| Net loss per share attributable to common stockholders-basic and diluted | $ | (0.40 | ) | $ | (1.09 | ) | $ | (2.02 | ) | $ | (3.08 | ) | ||||
| Weighted-average common stock outstanding-basic and diluted | 48,000,183 | 26,177,079 | 33,785,386 | 25,472,590 |