Full Press Release Details
Applied Therapeutics Reports Second Quarter
2024 Financial Results
for govorestat for treatment of Classic Galactosemia under FDA Priority Review and EMA review; PDUFA target action date of November 28,
2024, and EMA decision expected in early Q1 2025
Metabolic Diseases Advisory Committee (GeMDAC) Meeting to discuss NDA for govorestat for the treatment of Classic Galactosemia tentatively
scheduled for October 9, 2024
with the Neurology I Division on plans to submit an NDA under Accelerated Approval for govorestat for the treatment of SORD Deficiency;
Expect to submit an NDA in early Q1 2025
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 second quarter ended June 30, 2024.
"Momentum continues with our steady regulatory progress in Classic
Galactosemia and SORD Deficiency," said Shoshana Shendelman, PhD, Founder and CEO of Applied Therapeutics. "We are incredibly
pleased to share our alignment with the Neurology Division of the FDA regarding a potential second NDA submission for govorestat for the
treatment of SORD Deficiency. Both Galactosemia and SORD Deficiency are rare neurological diseases with no currently approved treatment
options. At Applied, we are dedicated to creating transformative treatments for rare diseases, and we continue to work closely with regulatory
agencies and patient advocacy groups to ensure that treatments become available for patients with these debilitating diseases."
| o | Hereditary Neuropathy Foundation (HNF) Charcot-Marie Tooth Syndrome (CMT) Summit, June 7-8 in San Diego, California; | |
| o | Charcot-Marie-Tooth Associate (CMTA) Strategy to Accelerate Research (STAR) Advisory Board meeting held June 21 in Montreal, Canada; | |
| o | Peripheral Nerve Society (PNS) 2024 Annual Meeting, held June 22-25 in Montreal, Canada; | |
| o | Sponsored and presented at the 2024 Galactosemia Foundation Conference, held July 18-20 in Concord, North Carolina. |
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 decision and (iii) statements related
to the scheduling or timing of any potential FDA or EMA meetings, interactions or submissions. 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
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
Julie Seidel/Andrew Vulis
Applied Therapeutics, Inc.
Condensed Balance Sheets
(in thousands, except share and per share data)
| As of | As of | |||||||
| June 30, | December 31, | |||||||
| 2024 | 2023 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 122,197 | $ | 49,898 | ||||
| Security deposits and leasehold improvements | 253 | 254 | ||||||
| Prepaid expenses and other current assets | 5,122 | 4,234 | ||||||
| Total current assets | 127,572 | 54,386 | ||||||
| Operating lease right-of-use asset | 206 | 447 | ||||||
| TOTAL ASSETS | $ | 127,778 | $ | 54,833 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY/(DEFICIT) | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Current portion of operating lease liabilities | $ | 185 | $ | 429 | ||||
| Accounts payable | 2,683 | 1,742 | ||||||
| Accrued expenses and other current liabilities | 10,296 | 15,286 | ||||||
| Warrant liabilities | 42,192 | 53,725 | ||||||
| Total current liabilities | 55,356 | 71,182 | ||||||
| NONCURRENT LIABILITIES: | ||||||||
| Noncurrent portion of operating lease liabilities | 30 | 38 | ||||||
| Clinical holdback - long-term portion | - | 759 | ||||||
| Total noncurrent liabilities | 30 | 797 | ||||||
| Total liabilities | 55,386 | 71,979 | ||||||
| STOCKHOLDERS' EQUITY/(DEFICIT): | ||||||||
| Common stock, $0.0001 par value; 250,000,000 shares authorized as of June 30, 2024 and 200,000,000 shares authorized as of December 31, 2023; 114,846,271 shares issued and outstanding as of June 30, 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 June 30, 2024 and December 31, 2023; 0 shares issued and outstanding as of June 30, 2024 and December 31, 2023 | - | - | ||||||
| Additional paid-in capital | 622,007 | 451,432 | ||||||
| Accumulated deficit | (549,626 | ) | (468,586 | ) | ||||
| Total stockholders' equity/(deficit) | 72,392 | (17,146 | ) | |||||
| TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY/(DEFICIT) | $ | 127,778 | $ | 54,833 |
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, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| REVENUE: | ||||||||||||||||
| License revenue | $ | - | $ | - | $ | - | $ | 10,660 | ||||||||
| Research and development services revenue | 144 | - | 334 | - | ||||||||||||
| Total revenue | 144 | - | 334 | 10,660 | ||||||||||||
| COSTS AND EXPENSES: | ||||||||||||||||
| Research and development | 10,004 | 11,883 | 22,221 | 27,818 | ||||||||||||
| General and administrative | 10,580 | 5,293 | 19,646 | 10,876 | ||||||||||||
| Total costs and expenses | 20,584 | 17,176 | 41,867 | 38,694 | ||||||||||||
| LOSS FROM OPERATIONS | (20,440 | ) | (17,176 | ) | (41,533 | ) | (28,034 | ) | ||||||||
| OTHER (EXPENSE) INCOME, NET: | ||||||||||||||||
| Interest income | 628 | 408 | 1,215 | 628 | ||||||||||||
| Change in fair value of warrant liabilities | 22,744 | (12,804 | ) | (40,660 | ) | (12,335 | ) | |||||||||
| Other (expense) income, net | (34 | ) | (5 | ) | (62 | ) | 27 | |||||||||
| Total other income (expense), net | 23,338 | (12,401 | ) | (39,507 | ) | (11,680 | ) | |||||||||
| Net income (loss) | $ | 2,898 | $ | (29,577 | ) | $ | (81,040 | ) | $ | (39,714 | ) | |||||
| Net income (loss) per share attributable to common stockholders-basic | $ | 0.02 | $ | (0.37 | ) | $ | (0.60 | ) | $ | (0.59 | ) | |||||
| Net income (loss) per share attributable to common stockholders-diluted | $ | (0.13 | ) | $ | (0.37 | ) | $ | (0.60 | ) | $ | (0.59 | ) | ||||
| Weighted-average common stock outstanding-basic | 143,934,239 | 79,041,695 | 134,627,942 | 67,762,501 | ||||||||||||
| Weighted-average common stock outstanding-diluted | 152,392,748 | 79,041,695 | 134,627,942 | 67,762,501 |