Full Press Release Details
Applied Therapeutics Reports Fourth Quarter
and Year-end 2023 Financial Results
govorestat accepted and granted Priority Review by FDA for the treatment of Classic Galactosemia; PDUFA target action date of August 28,
2024; MAA under review by EMA with decision expected in 4Q 2024
positive results from 12-month interim analysis of govorestat in ongoing INSPIRE Phase 3 trial in SORD Deficiency; Company plans to request
pre-NDA meeting with neurology division of FDA
balance sheet with $100 million Private Placement, expected to extend cash runway into 2026
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 fourth quarter and full year ended December 31, 2023.
"We've made significant clinical and regulatory progress,
particularly with the NDA acceptance and MAA validation for govorestat for the treatment of Galactosemia, achieving key milestones for
our rare disease pipeline. Additionally, we believe that the recent positive data from the interim analysis of the INSPIRE study in SORD
Deficiency confirms the role of sorbitol as a key driver of disease progression, and we plan to request a pre-NDA meeting with the FDA,"
said Shoshana Shendelman, PhD, Founder, Chief Executive Officer, and Chair of the Board. "As Applied enters into this next stage
of growth, we are poised for continued value generation across our rare disease pipeline, supported by our recent financing and bolstered
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 extend into 2026; (ii) Company's
plans to request a pre-NDA meeting with the FDA; and (iii) the likelihood that the Company's ongoing NDA and MMA submissions
will be approved and the timing of any approval decision. 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 or otherwise.
Applied Therapeutics, Inc.
(in thousands except share and per share data)
| As of | As of | |||||||
| December 31, | December 31, | |||||||
| 2023 | 2022 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 49,898 | $ | 16,657 | ||||
| Investments | - | 13,923 | ||||||
| Current portion of security deposits and leasehold improvements | 254 | 57 | ||||||
| Prepaid expenses and other current assets | 4,234 | 6,671 | ||||||
| Total current assets | 54,386 | 37,308 | ||||||
| Noncurrent portion of security deposits and leasehold improvements | - | 198 | ||||||
| Operating lease right-of-use asset | 447 | 857 | ||||||
| TOTAL ASSETS | $ | 54,833 | $ | 38,363 | ||||
| LIABILITIES AND STOCKHOLDERS' (DEFICIT)/EQUITY | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Current portion of operating lease liabilities | $ | 429 | $ | 477 | ||||
| Accounts payable | 1,742 | 4,534 | ||||||
| Accrued expenses and other current liabilities | 15,286 | 14,756 | ||||||
| Warrant liabilities | 53,725 | 13,657 | ||||||
| Total current liabilities | 71,182 | 33,424 | ||||||
| NONCURRENT LIABILITIES: | ||||||||
| Noncurrent portion of operating lease liabilities | 38 | 414 | ||||||
| Clinical holdback - long-term portion | 759 | 464 | ||||||
| Total noncurrent liabilities | 797 | 878 | ||||||
| Total liabilities | 71,979 | 34,302 | ||||||
| STOCKHOLDERS' (DEFICIT)/EQUITY: | ||||||||
| Common stock, $0.0001 par value; 200,000,000 shares authorized as of December 31, 2023 and December 31, 2022; 84,869,832 shares issued and outstanding as of December 31, 2023 and 48,063,358 shares issued and outstanding as of December 31, 2022 | 8 | 5 | ||||||
| Preferred stock, par value $0.0001; 10,000,000 shares authorized as of December 31, 2023 and December 31, 2022; 0 shares issued and outstanding as of December 31, 2023 and December 31, 2022 | - | - | ||||||
| Additional paid-in capital | 451,432 | 352,828 | ||||||
| Accumulated other comprehensive income | - | 51 | ||||||
| Accumulated deficit | (468,586 | ) | (348,823 | ) | ||||
| Total stockholders' (deficit)/equity | (17,146 | ) | 4,061 | |||||
| TOTAL LIABILITIES AND STOCKHOLDERS' (DEFICIT)/EQUITY | $ | 54,833 | $ | 38,363 |
Applied Therapeutics, Inc.
Statements of Operations
(in thousands except share and per share data)
| Year Ended | ||||||||
| December 31, | ||||||||
| 2023 | 2022 | |||||||
| REVENUE: | ||||||||
| License revenue | $ | 9,219 | $ | - | ||||
| Research and development services revenue | 774 | - | ||||||
| Total revenue | 9,993 | - | ||||||
| COSTS AND EXPENSES | ||||||||
| Research and development | 53,905 | 55,634 | ||||||
| General and administrative | 20,623 | 27,316 | ||||||
| Total operating expenses | 74,528 | 82,950 | ||||||
| LOSS FROM OPERATIONS | (64,535 | ) | (82,950 | ) | ||||
| OTHER INCOME (EXPENSE), NET: | ||||||||
| Interest income | 1,372 | 685 | ||||||
| Change in fair value of warrant liabilities | (56,573 | ) | (66 | ) | ||||
| Other expense | (27 | ) | (177 | ) | ||||
| Total other income (expense), net | (55,228 | ) | 442 | |||||
| Net loss | $ | (119,763 | ) | $ | (82,508 | ) | ||
| Net loss per share attributable to common stockholders-basic and diluted | $ | (1.42 | ) | $ | (2.18 | ) | ||
| Weighted-average common stock outstanding-basic and diluted | 84,244,494 | 37,825,431 |