Applied Therapeutics Reports $105.6 Million Net Loss for 2024, Revenue Declines to $0.5 Million

Applied Therapeutics Inc. reported a net loss of $105.6 million for the year ended December 31, 2024, compared to a net loss of $119.8 million in 2023. Revenue for 2024 was $0.5 million, a decrease of $9.5 million from the $10 million reported in 2023. This decrease stemmed from a $9.2 million drop in license revenue due to a lack of new licensing arrangements in 2024 and a $0.3 million decrease in research and development services revenue. The company's accumulated deficit as of December 31, 2024, stood at $574.2 million. The company's independent registered public accounting firm included a "going concern" explanatory paragraph in its report, citing substantial doubt about the company's ability to continue as a going concern for 12 months beyond the filing date.

Research and development expenses decreased by $5.2 million to $48.7 million in 2024, primarily due to a $12 million reduction in clinical and pre-clinical expenses related to AT-001, partially offset by increased spending on AT-007. General and administrative expenses increased by $35.4 million to $56 million, largely driven by increases in legal and professional fees ($8.1 million), commercial expenses ($18.3 million), and personnel expenses ($4.7 million), partially offset by a decrease in insurance expenses. The company's cash and cash equivalents totaled $79.4 million as of December 31, 2024.

Significant developments during the year included the FDA's acceptance of a New Drug Application (NDA) for AT-007 for the treatment of Classic Galactosemia in February 2024, followed by a Complete Response Letter and a Warning Letter in November 2024. Consequently, the company withdrew its Marketing Authorization Application (MAA) to the European Medicines Agency (EMA). The company also reported topline results from its ARISE-HF Phase 2/3 trial for AT-001 in diabetic cardiomyopathy, showing a trend towards stabilizing cardiac functional capacity, although the difference from placebo was not statistically significant in the primary endpoint. The company discontinued its preclinical PI3K program and returned AT-104 to Columbia University. The company also entered into an exclusive license and supply agreement with Advanz Pharma for the commercialization of AT-007 in Europe.

The company's financial performance was also impacted by several financing activities. These included a private placement in April 2023 that raised $27.5 million, sales of common stock under a Leerink ATM Agreement generating $12.4 million in net proceeds during 2024, a warrant exchange with Venrock Healthcare Capital Partners, and a private placement in March 2024 that raised $92.3 million in gross proceeds. The company also experienced significant changes in its leadership, with the departure of its founder and CEO in December 2024 and the appointment of an interim CEO and executive chairman. As of December 31, 2024, the company had 35 full-time employees.

The company's outlook remains uncertain, contingent upon the successful resolution of the FDA's concerns regarding AT-007 and the outcome of its ongoing clinical trials. The company plans to meet with the FDA to discuss potential NDA submissions for AT-007 in SORD Deficiency, and intends to initiate a clinical development program for AT-007 in PMM2-CDG. The company also noted several risk factors, including substantial operating losses, dependence on additional funding, competition, regulatory uncertainties, and the risks associated with third-party collaborations and manufacturing. The company does not anticipate paying cash dividends in the foreseeable future.