On August 11, 2020 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, 2020 (Press release, Applied Therapeutics, AUG 11, 2020, View Source [SID1234563392]).
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"The second quarter was an exciting time for the Company, as we continued to advance our late stage programs towards regulatory submission and commercial launch," said Shoshana Shendelman, PhD, Founder, CEO and Chair of the Board of Applied Therapeutics. "As we move through the rest of the year, we remain focused on our commitment to bringing drugs to patients in urgent need of treatment across multiple diseases, which we believe will ultimately drive shareholder value."
Recent Highlights
Presented Data on AT-007 for Treatment of Galactosemia at the Galactosemia Foundation 2020 Virtual Conference. In July 2020, we presented data and provided an overview of the AT-007 Galactosemia development program at the Galactosemia Foundation 2020 Virtual Conference, a unique platform that brings together patients and families with Galactosemia alongside researchers and physicians.
Announced Start of AT-007 Pediatric Galactosemia Study; Released Additional 40mg/kg Data from Adult Galactosemia Study. June 2020, we announced additional supportive biomarker efficacy and safety data for AT-007 in Galactosemia at 40 mg/kg. The data announced showed once-daily 40 mg/kg AT-007 resulted in plasma galactitol reduction of 55% and a rapid, sustained and statistically significant reduction in galactitol vs. placebo. 40mg/kg was safe and well-tolerated with no drug-related adverse events reported, and no compensatory increase in galactose or other metabolites, such as Gal-1p. We also announced initiation of the AT-007 pediatric trial, ACTION-Galactosemia Kids, in children age 2 to 17.
Presented Data on AT-001 for the Treatment of Diabetic Cardiomyopathy at 2020 American Diabetes Association (ADA) Virtual Scientific Sessions. In June 2020, we presented data at the ADA 80th Scientific Sessions. The presentations included comprehensive data on our aldose reductase inhibitor program and mechanistic data on the role of aldose reductase during hyperglycemia. The presentations included data on the structural basis and rational drug design behind our next generation aldose reductase inhibitors, as well as data elucidating the mechanisms by which AT-001 prevents cellular damage responsible for diabetic complications.
Appointed Dr. Chuck Silberstein, MD, MBA, CFA as Chief Financial Officer and Head of Business Development. In May 2020, we announced the appointment of Dr. Silberstein, formerly Senior Vice President of Corporate Business Development at Allergan plc, as Chief Financial Officer and Head of Business Development. Along with broad corporate strategy and business development skills, Dr. Silberstein brings more than 20 years of investment and capital markets experience to Applied Therapeutics.
Financial Results
Cash and cash equivalents and short-term investments totaled $138.5 million as of June 30, 2020 compared with $154.3 million at March 31, 2020.
Research and development expenses for the three months ended June 30, 2020 were $20.8 million, compared to $4.3 million for the three months ended June 30, 2019. For the three months ended June 30, 2020, the increase of $16.5 million was primarily due to an increase in clinical and pre-clinical expense of $7.5 million, primarily related to the progression of the AT-007 ACTION-Galactosemia, and the AT-001 Phase 3 ARISE-HF clinical studies, as well as the commencement of the ACTION-Galactosemia Kids pediatric registrational study; an increase in drug manufacturing and formulation costs of $9.2 million primarily related to the timing of raw material deliveries in support of the 2020 manufacturing campaigns and the completion and release of AT-001 and AT-007 drug product batches; an increase in personnel expenses of $0.2 million due to the increase in headcount in support of our clinical program pipeline; and an increase in regulatory and other expenses of $0.4 million relating to an increase in license fees during the three months ended June 30, 2020. This was partially offset by a decrease in stock-based compensation of $0.8 million due to the increased modification expense recognized during the three months ended June 30, 2019 relating to the acceleration of certain options vesting following the IPO.
General and administrative expenses General and administrative expenses were $7.5 million for the three months ended June 30, 2020, compared to $4.2 million for the three months ended June 30, 2019. For the three months ended June 30, 2020, the increase of $3.3 million was primarily related to the increase in personnel expenses of $1.3 million due to the increase in headcount, $1.1 million related to an increase in legal and professional fees due to increased costs associated with being a public company, $0.8 million related to the establishment of a commercial department, $0.5 million related to increased insurance costs, and $0.3 million in other expenses relating to increased costs of rent and other office expenses. This was partially offset by the decrease of $0.7 million in stock-based compensation expense, due to the additional modification expense recognized in April 2019 for acceleration of certain options vesting following the IPO.
Net loss for the second quarter of 2020 was $28.1 million, or $1.27 per basic and diluted common share, compared to a net loss of $ 8.4 million, or $ 0.60 per basic and diluted common share, for the second quarter 2019.