Page 1

a THERAPEUTICS Applied Therapeutics Reports Second Quarter 2021 Financial Results August 12 , 2021 NDA submission for AT - 007 in Galactosemia expected in Q3 2021 ; commercial preparations ongoing Ended Q2 2021 with a strong balance sheet with $ 125.6 million in cash and cash equivalents and short - term investments NEW YORK , Aug. 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 second quarter ended June 30 , 2021 . " Our pediatric Galactosemia program advanced significantly in the second quarter , " said Shoshana Shendelman , PhD , CEO , Founder and Chair of the Board of Applied Therapeutics . " We continue to prepare for our NDA submission the third quarter and our anticipated commercial launch in 2022 . We are excited to launch our registrational study in SORD and complete enrollment in ARISE - HF , both of which are expected later this year . " Recent Highlights • Granted Fast Track Designation by FDA for AT - 007 for Galactosemia . In June 2021 , the U.S Food and Drug Administration ( FDA ) granted Fast Track Designation to AT - 007 for the treatment of Galactosemia . Applied Therapeutics plans to submit a New Drug Application ( NDA ) for Accelerated Approval of AT - 007 for the treatment of Galactosemia in the third quarter of this year . FDA had previously granted Orphan Drug Designation and Pediatric Rare Disease status to AT - 007 for Galactosemia . • Presented Data on the Prevalence of Diabetic Cardiomyopathy ( DbCM ) at the 81st Scientific Sessions of the 2021 Annual Meeting of the American Diabetes Association . In June 2021 , the Company announced data presentations confirming the high prevalence of DbCM in adults with diabetes or pre - diabetes . The analysis estimated that ~ 1 in 5 people with diabetes or pre - diabetes have DbCM , a serious and progressive disease that limits the heart's ability to function . The Phase 3 registrational ARISE - HF study evaluating AT - 001 in patients with DbCM continues to enroll . • Added to Russell Microcap® Index . In June 2021 , the Company announced that it had joined the Russell Microcap Index , effective after the market close on Friday , June 25 , 2021. Membership in the Russell Microcap® Index , which remains in place for one year , means automatic inclusion in the appropriate growth and value style indexes . FTSE Russell determines membership for its Russell indexes primarily by objective , market - capitalization rankings and style attributes . • Presented Data on Galactosemia Disease Progression at the 2021 Annual Clinical Genetics Meeting of the American College of Medical Genetics and Genomics . In April 2021 , the Company presented data featuring a cross sectional analysis of nineteen pediatric patients with Classic Galactosemia , providing meaningful insight on the progressive worsening of the central nervous system phenotype with age . Financial Results • Cash and cash equivalents and short - term investments totaled $ 125.6 million as of June 30 , 2021 , compared with $ 148.1 million at March 31 , 2021 . • Research and development expenses for the three months ended June 30 , 2021 were $ 14.8 million , compared to $ 20.8 million for the three months ended June 30 , 2020. The decrease of $ 6.0 million was related to a decrease in drug manufacturing and formulation costs of $ 7.1 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 ; a decrease in stock - based compensation of $ 0.1 million due to forfeitures of stock option and restricted stock unit grants related to personnel terminations ; an increase in clinical and pre - clinical expense of $ 0.9 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 ; and an increase in personnel expenses of $ 0.3 million due to the increase in headcount in support of our clinical program pipeline . • General and administrative expenses were $ 11.1 million for the three months ended June 30 , 2021 , compared to $ 7.5 million for the three months ended June 30 , 2020. The increase of $ 3.6 million was primarily related to an increase of $ 1.9 million related to the expansion of the commercial department ; an increase in stock - based compensation of $ 1.1 million related to an increase in headcount ; an increase of $ 0.2 million related to increased insurance costs ; an increase of $ 0.9 million in other expenses related to increased costs of rent and other office expenses ; and a decrease of $ 0.4 million in