Full Press Release Details
Applied Therapeutics Reports Fourth Quarter
and Year-end 2022 Financial Results
Progress in Three Phase 3 Trials in Areas of
High Unmet Clinical Need, Including Positive Sorbitol Reduction Data from the Ongoing Phase 3 INSPIRE Trial in Sorbitol Dehydrogenase
On Track to Report Additional Phase 3 Data Across
Multiple Programs in 2023
2023 - 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 fourth quarter and full year ended December 31, 2022.
are pleased with the clinical progress in 2022 across all three of our registrational Phase 3 programs, and we look forward to the data
readouts in the year ahead," said Shoshana Shendelman, PhD, Founder and CEO of Applied Therapeutics. "Our recent deal with
Advanz Pharma highlights our ability to realize value in our clinical programs, and we continue to evaluate other potential opportunities
for value recognition."
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 (govorestat), 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 the 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 anticipated benefits
of the Company's partnership with Advanz Pharma and (ii) the expected development milestone payments. 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) our ability to achieve the anticipated benefits from the agreements entered into in connection
with our partnership with Advanz Pharma 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.
Statements of Operations
(in thousands except share and per share data)
| Year Ended | ||||||||
| December 31, | ||||||||
| 2022 | 2021 | |||||||
| OPERATING EXPENSES: | ||||||||
| Research and development | $ | 55,634 | $ | 62,570 | ||||
| General and administrative | 27,316 | 43,048 | ||||||
| Total operating expenses | 82,950 | 105,618 | ||||||
| LOSS FROM OPERATIONS | (82,950 | ) | (105,618 | ) | ||||
| OTHER INCOME (EXPENSE), NET: | ||||||||
| Interest income | 685 | 555 | ||||||
| Change in fair value of warrant liabilities | (66 | ) | - | |||||
| Other expense | (177 | ) | (521 | ) | ||||
| Total other income, net | 442 | 34 | ||||||
| Net loss | $ | (82,508 | ) | $ | (105,584 | ) | ||
| Net loss attributable to common stockholders-basic and diluted | $ | (82,508 | ) | $ | (105,584 | ) | ||
| Net loss per share attributable to common stockholders-basic and diluted | $ | (2.18 | ) | $ | (4.12 | ) | ||
| Weighted-average common stock outstanding-basic and diluted | 37,825,431 | 25,598,181 |
Applied Therapeutics, Inc.
(in thousands except share and per share data)
| As of | As of | |||||||
| December 31, | December 31, | |||||||
| 2022 | 2021 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 16,657 | $ | 53,888 | ||||
| Investments | 13,923 | 26,935 | ||||||
| Prepaid expenses and other current assets | 6,728 | 7,571 | ||||||
| Total current assets | 37,308 | 88,394 | ||||||
| Operating lease right-of-use asset | 857 | 1,298 | ||||||
| Security deposits and leasehold improvements | 198 | 200 | ||||||
| TOTAL ASSETS | $ | 38,363 | $ | 89,892 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Current portion of operating lease liabilities | $ | 477 | $ | 442 | ||||
| Accounts payable | 4,534 | 9,461 | ||||||
| Accrued expenses and other current liabilities | 14,756 | 16,559 | ||||||
| Warrant liability | 13,657 | - | ||||||
| Total current liabilities | 33,424 | 26,462 | ||||||
| NONCURRENT LIABILITIES: | ||||||||
| Noncurrent portion of operating lease liabilities | 414 | 891 | ||||||
| Clinical holdback - long-term portion | 464 | - | ||||||
| Total noncurrent liabilities | 878 | 891 | ||||||
| Total liabilities | 34,302 | 27,353 | ||||||
| STOCKHOLDERS' EQUITY: | ||||||||
| Common stock, $0.0001 par value; 200,000,000 shares authorized as of December 31, 2022 and 100,000,000 shares authorized as of December 31, 2021; 48,063,358 shares issued and outstanding as of December 31, 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 December 31, 2022 and December 31, 2021; 0 shares issued and outstanding as of December 31, 2022 and December 31, 2021 | - | - | ||||||
| Additional paid-in capital | 352,828 | 328,958 | ||||||
| Accumulated other comprehensive gain/(loss) | 51 | (107 | ) | |||||
| Accumulated deficit | (348,823 | ) | (266,315 | ) | ||||
| Total stockholders' equity | 4,061 | 62,539 | ||||||
| TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ | 38,363 | $ | 89,892 |