Full Press Release Details
Applied Therapeutics Reports First Quarter 2024
NDA for Classic Galactosemia under Priority Review, PDUFA target action date of November 28, 2024
MAA under review by EMA; Day 120 3-month clock-stop extension granted; decision expected in early Q1 2025
discussing potential NDA submission under Accelerated Approval for govorestat for treatment of SORD Deficiency with Neurology I Division
YORK, May 9, 2024 - 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 first quarter ended March 31, 2024.
"Preparations are underway for the potential approval and commercial
launch of govorestat for the treatment of Classic Galactosemia in the US and EU, following the significant regulatory progress we have
already made in 2024," said Shoshana Shendelman, PhD, Founder and CEO of Applied Therapeutics. "We are also discussing a potential
NDA submission for SORD Deficiency with the Neurology Division at FDA, further advancing our objective of bringing first ever treatment
to patients with rare diseases."
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, 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," "predicts" 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 the
(i) Company's expectation that its cash and cash equivalents will fund the business into 2026; (ii) the likelihood that
the Company's ongoing NDA and MMA submissions will be approved and the timing of any approval decision and (iii) statements
related to the potential commercial launch of govorestat. 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, (xviii) 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
Applied Therapeutics, Inc.
Condensed Balance Sheets
(in thousands, except share and per share data)
| As of | As of | |||||||
| March 31, | December 31, | |||||||
| 2024 | 2023 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 146,484 | $ | 49,898 | ||||
| Security deposits and leasehold improvements | 253 | 254 | ||||||
| Prepaid expenses and other current assets | 4,169 | 4,234 | ||||||
| Total current assets | 150,906 | 54,386 | ||||||
| Operating lease right-of-use asset | 328 | 447 | ||||||
| TOTAL ASSETS | $ | 151,234 | $ | 54,833 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY/(DEFICIT) | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Current portion of operating lease liabilities | $ | 308 | $ | 429 | ||||
| Accounts payable | 4,019 | 1,742 | ||||||
| Accrued expenses and other current liabilities | 14,641 | 15,286 | ||||||
| Warrant liabilities | 64,937 | 53,725 | ||||||
| Total current liabilities | 83,905 | 71,182 | ||||||
| NONCURRENT LIABILITIES: | ||||||||
| Noncurrent portion of operating lease liabilities | 35 | 38 | ||||||
| Clinical holdback - long-term portion | - | 759 | ||||||
| Total noncurrent liabilities | 35 | 797 | ||||||
| Total liabilities | 83,940 | 71,979 | ||||||
| STOCKHOLDERS' EQUITY/(DEFICIT): | ||||||||
| Common stock, $0.0001 par value; 200,000,000 shares authorized as of March 31, 2024 and December 31, 2023; 114,241,803 shares issued and outstanding as of March 31, 2024 and 84,869,832 shares issued and outstanding as of December 31, 2023 | 11 | 8 | ||||||
| Preferred stock, par value $0.0001; 10,000,000 shares authorized as of March 31, 2024 and December 31, 2023; 0 shares issued and outstanding as of March 31, 2024 and December 31, 2023 | - | - | ||||||
| Additional paid-in capital | 619,807 | 451,432 | ||||||
| Accumulated deficit | (552,524 | ) | (468,586 | ) | ||||
| Total stockholders' equity/(deficit) | 67,294 | (17,146 | ) | |||||
| TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY/(DEFICIT) | $ | 151,234 | $ | 54,833 |
Applied Therapeutics, Inc.
Condensed Statements of Operations
(in thousands, except share and per share data)
| Three Months Ended | ||||||||
| March 31, | ||||||||
| 2024 | 2023 | |||||||
| REVENUE: | ||||||||
| License revenue | $ | - | $ | 10,660 | ||||
| Research and development services revenue | 190 | - | ||||||
| Total revenue | 190 | 10,660 | ||||||
| COSTS AND EXPENSES: | ||||||||
| Research and development | 12,217 | 15,935 | ||||||
| General and administrative | 9,066 | 5,583 | ||||||
| Total costs and expenses | 21,283 | 21,518 | ||||||
| LOSS FROM OPERATIONS | (21,093 | ) | (10,858 | ) | ||||
| OTHER (EXPENSE) INCOME, NET: | ||||||||
| Interest income | 586 | 221 | ||||||
| Change in fair value of warrant liabilities | (63,405 | ) | 469 | |||||
| Other expense | (26 | ) | 31 | |||||
| Total other (expense) income, net | (62,845 | ) | 721 | |||||
| Net loss | $ | (83,938 | ) | $ | (10,137 | ) | ||
| Net loss per share attributable to common stockholders-basic and diluted | $ | (0.67 | ) | $ | (0.18 | ) | ||
| Weighted-average common stock outstanding-basic and diluted | 125,318,993 | 56,357,983 |