NEW YORK, May 11, 2020 (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 first quarter ended March 31, 2020.

“The first quarter was a period of tremendous growth and advancement across our clinical programs,” said Shoshana Shendelman, PhD, Founder, CEO and Chair of the Board of Applied Therapeutics. “We also began building out our commercial infrastructure in preparation for future launches, including Galactosemia. The company remains well capitalized as a result of the financing in January, and we look forward to continuing our momentum throughout the rest of this year - launching our pediatric study in Galactosemia, continuing enrollment on the DbCM ARISE-HF study, and advancing additional new programs forward into the clinic.”

Recent Highlights

• Announced Full Data and Scientific Presentations from the Pivotal Phase 2 ACTION-Galactosemia Trial. In April 2020, we announced new data and scientific presentations from the pivotal Phase 2 ACTION-Galactosemia trial. The topline data from the trial was originally announced in early January. The full study data, originally planned to be presented at the Society for Inherited Metabolic Disorders conference, showed that once-daily 20mg/kg AT-007 rapidly and sustainably reduced toxic galactitol levels with no accompanying increase in galactose. Additionally, positive trends on MRI outcomes were shown, including indirect measures of edema, neuronal health and brain galactitol levels in AT-007-treated patients. As no drug-related adverse events were seen at the once-daily 20mg/kg dose, a once-daily 40mg/kg dose was subsequently studied in healthy volunteers, and was also shown to be safe and well-tolerated. Evaluation of the 40 mg/kg dose in Galactosemia patients remains ongoing.
• Announced IND and Investigator-Initiated Studies of AT-001 in Critical COVID-19 Patients. In April 2020, we announced that a COVID-19 IND has been opened with the FDA for AT-001, a novel potent Aldose Reductase inhibitor. Multiple AT-001 investigator-initiated trials are currently underway to address acute lung inflammation and cardiomyopathy in critical COVID-19 patients. Several New York City hospitals have initiated Emergency Investigational Drug applications for AT-001 use in critical COVID-19 patients. Additional data is being gathered through studies on the effect of AT-001 therapy in critical COVID-19 patients.
• Appointed Adam Hansard as Chief Commercial Officer. In March 2020, we announced the appointment of Adam Hansard as Chief Commercial Officer. Mr. Hansard brings extensive commercial and leadership experience across the biotech and pharmaceutical industry to Applied Therapeutics.
• Closed $143.4 Million Underwritten Public Offering. In January 2020, we completed an underwritten public offering of common stock at a price to the public of $45.50 per share, resulting in gross proceeds of approximately $143.4 million, before deducting underwriting discounts and commissions and offering expenses.

Financial Results

• Cash and cash equivalents and short-term investments totaled $154.3 million as of March 31, 2020, compared with $38.9 million at December 31, 2019.
• Research and development expenses for the three months ended March 31, 2020 were $7.3 million, compared to $6.9 million for the three months ended March 31, 2019. The increase of approximately $0.4 million was primarily related to the increase in clinical and pre-clinical expenses of $0.8 million for the advancement of clinical trials, increase in personnel-related costs of $0.2 million and $0.5 million increase in stock-based compensation expense due to an increase in headcount, which were offset by the decrease in drug manufacturing and formulation expenses of $1.0 million and decrease in regulatory and other expenses of $0.1 million.
• General and administrative expenses were $5.2 million for the three months ended March 31, 2020, compared to $1.9 million for the three months ended March 31, 2019. The increase of approximately $3.3 million was primarily related to the increase in personnel expenses and stock-based compensation of $0.4 million and $0.5 million, respectively, due to the increase in headcount, including the hiring of the chief financial officer and chief accounting officer, $1.3 million related to an increase in legal and professional fees due to increased costs associated with being a public company, and $1.2 million in other expenses relating to increased costs of insurance, rent, and other office expenses.
• Net loss for the first quarter of 2020 was $12.4 million, or $0.59 per basic and diluted common share, compared to a net loss of $8.7 million, or $1.58 per basic and diluted common share, for the first quarter 2019.

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, AT-007, is a novel central nervous system penetrant aldose reductase inhibitor (ARI) for the treatment of Galactosemia, a rare pediatric metabolic disease. The Company initiated a Phase 1/2 clinical trial in June 2019 and read out positive top-line biomarker data in adult Galactosemia patients in January of 2020. The Company is also developing AT-001, a novel potent ARI that is being developed for the treatment of Diabetic Cardiomyopathy, or DbCM, a fatal fibrosis of the heart. The Company initiated a Phase 3 registrational study in DbCM in September 2019. 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, expected to advance into a Phase 1 study in 2020, as well as novel dual PI3k inhibitors in preclinical development for orphan oncology indications.