Applied Therapeutics Reports $21.8 Million Net Loss in Q1 2025, Revenue Drops to $0

Applied Therapeutics Inc. reported a net loss of $21.8 million for the first quarter of 2025, a significant decrease from the $83.9 million loss recorded in the same period of the previous year. The company’s total revenue for the quarter was $0, down from $190,000 in the first quarter of 2024, primarily due to a reduction in research and development services revenue associated with the Advanz Agreement. Total expenses for the quarter increased to $25.5 million from $21.3 million year-over-year, driven by a rise in general and administrative costs, which surged to $17.7 million from $9.1 million, largely due to legal fees related to ongoing litigation.

In terms of operational metrics, Applied Therapeutics had 141,575,526 shares of common stock outstanding as of March 31, 2025, an increase from 137,228,741 shares at the end of 2024. The company’s cash and cash equivalents stood at $50.8 million, a decrease from $79.4 million at the end of the previous fiscal year. The increase in share count reflects ongoing financing efforts, including the issuance of common stock and pre-funded warrants. The company has not yet established a consistent revenue stream to cover its operating costs and remains dependent on external financing to fund its operations.

Strategically, Applied Therapeutics is focused on advancing its lead product candidate, AT-007 (govorestat), which is under review by the FDA for the treatment of Classic Galactosemia. However, the company received a Complete Response Letter from the FDA in November 2024, indicating that the NDA could not be approved in its current form due to deficiencies in the clinical application. The company is actively working to address these issues and is also evaluating its development program for SORD deficiency, another indication for AT-007. The company has entered into a licensing agreement with Advanz Pharma for commercialization rights in Europe, which may provide additional funding opportunities contingent on successful regulatory submissions.

Looking ahead, Applied Therapeutics faces significant challenges, including the need for substantial additional funding to support its ongoing clinical trials and operations. The company has acknowledged substantial doubt regarding its ability to continue as a going concern within the next twelve months, emphasizing the importance of securing additional capital. The ongoing litigation, including a securities class action lawsuit and a shareholder derivative action, adds further uncertainty to the company’s financial outlook. The management is committed to addressing these challenges while continuing to pursue its clinical development programs.