NEW YORK, Nov. 09, 2022 (GLOBE NEWSWIRE) -- 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.
“In 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.”
Recent Highlights
Financial Results
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 otherwise.
Contacts
Investors:
Maeve Conneighton
(212) 600-1902 or
appliedtherapeutics@argotpartners.com
Media:
media@appliedtherapeutics.com
Applied Therapeutics, Inc.
Condensed Balance Sheets
(in thousands, except share and per share data) As of As of September 30, December 31, 2022 2021 (Unaudited) 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)
(Unaudited) 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