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Applied Therapeutics Reports Fourth Quarter and Year-end 2023 Financial Results

NEW YORK, March 06, 2024 (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 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 cash position.”

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, 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.

Contacts

Investors:
Maeve Conneighton
(212) 600-1902 or
appliedtherapeutics@argotpartners.com

Media:
media@appliedtherapeutics.com

Applied Therapeutics, Inc.
Balance Sheets
(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)
(Unaudited)
               
      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  


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