On August 12, 2021 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, reported financial results for the second quarter ended June 30, 2021 (Press release, Applied Therapeutics, AUG 12, 2021, View Source [SID1234586467]).
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"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 in 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 legal and professional fees due to lower external legal fees.
Net loss for the second quarter of 2021 was $25.8 million, or $0.99 per basic and diluted common share, compared to a net loss of $28.1 million, or $1.27 per basic and diluted common share, for the second quarter 2020.