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a THERAPEUTICS Applied Therapeutics Reports Third Quarter 2021 Financial Results November 12 , 2021 Data from pilot trial of AT - 007 in SORD deficiency expresses substantial and significant reduction in sorbitol Data from the ACTION - Galactosemia Kids study demonstrates statistically significant reduction in plasma galactitol NEW YORK , Nov. 12 , 2021 ( GLOBE NEWSWIRE ) Applied Therapeutics , Inc. ( Nasdaq : APLT ) , 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 , 2021 . " This quarter we announced positive data in both the Galactosemia pediatric study as well as our pilot SORD Deficiency study , highlighting our execution across programs and expansion into additional indications with AT - 007 , " said Shoshana Shendelman , PhD , CEO , Founder and Chair of the Board of Applied Therapeutics . " We are excited to launch our registrational study in SORD later this year and remain focused on preparations for our anticipated commercial launch in Galactosemia in 2022. " Recent Highlights • Reported biomarker data from pilot trial of AT - 007 in SORD deficiency . In October 2021 , the Company highlighted results from a pilot open - label study in 8 SORD Deficiency patients . In the study , AT - 007 reduced blood sorbitol levels by approximately 66 % from baseline through 30 days of treatment with a range of reduction from baseline of 54 % -75 % . AT - 007 was safe and well tolerated in all patients . The Company plans to initiate a registrational study by the end of 2021 . • Reported pediatric biomarker data from ACTION - Galactosemia Kids . In October 2021 , the Company reported pediatric biomarker data from the ACTION - Galactosemia Kids study . The results demonstrated a substantial reduction in plasma galactitol of approximately 40 % , which was statistically significant ( p < 0.001 ) vs. placebo . Additionally , analysis of the 47 children in the ACTION - Galactosemia Kids study demonstrated a clear correlation between baseline galactitol level and baseline clinical functional outcomes . Children with higher plasma galactitol levels displayed greater disease severity vs. children with lower plasma galactitol levels at baseline . This data is the first demonstration of correlation of a biochemical biomarker with severity of disease in Galactosemia patients . This data will be presented as a late - breaking abstract at the 14th International Congress on Inborn Errors of Metabolism ( ICIEM ) November 21-24 , 2021 . Financial Results • Cash and cash equivalents and short - term investments totaled $ 108.8 million as of September 30 , 2021 , compared with $ 125.6 million at June 30 , 2021 . • Research and development expenses for the three months ended September 30 , 2021 were $ 17.6 million , compared to $ 19.9 million for the three months ended September 30 , 2020. The decrease of $ 2.3 million was related to a decrease in drug manufacturing and formulation costs of $ 5.2 million primarily related to the completion and release of AT - 001 and AT - 007 drug product batches in the three months ended March 31 , 2021 ; an increase in clinical and pre - clinical expense of $ 2.1 million , primarily related to the progression of the AT - 007 ACTION - Galactosemia adult extension study and the AT - 007 ACTION - Galactosemia Kids pediatric registrational study ; an increase in personnel expenses of $ 0.6 million due to the increase in headcount in support of our clinical program pipeline ; and an increase in regulatory and other expenses of $ 0.2 million . • General and administrative expenses were $ 10.8 million for the three months ended September 30 , 2021 , compared to $ 10.0 million for the three months ended September 30 , 2020. The increase of $ 0.8 million was primarily related to an increase in commercial expenses of $ 0.8 million related to the expansion of the commercial department ; an increase in other expenses of $ 0.3 million relating to increased costs of rent and other office expenses ; an increase in stock - based compensation of $ 0.2 million ; an increase in insurance expenses of $ 0.1 million related to increased insurance costs ; and a decrease in legal and professional fees $ 0.6 million due to lower external legal fees . • Net loss for the third quarter of 2021 was $ 28.4 million , or $ 1.09 per basic and diluted common share , compared to a net loss of $ 29.8 million , or $ 1.33 per basic and diluted common share , for the third quarter 2020 . About Applied Therapeutics