Applied Therapeutics ( (APLT) ) has released its Q3 earnings. Here is a breakdown of the information Applied Therapeutics presented to its investors.
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Applied Therapeutics is a clinical-stage biopharmaceutical company focused on developing innovative drug candidates targeting significant unmet medical needs, particularly in rare metabolic diseases. The company’s lead product candidate is govorestat, aimed at treating conditions like Galactosemia and SORD Deficiency.
In its latest earnings report, Applied Therapeutics highlighted significant progress in its regulatory journey, with the NDA for govorestat under FDA Priority Review for Classic Galactosemia and another NDA submission planned for SORD Deficiency. The company is gearing up for a pivotal transition from a clinical-stage entity to a commercial organization.
Key financial metrics revealed that the company had cash and equivalents totaling $98.9 million as of September 30, 2024, reflecting a strong financial position compared to $49.9 million at the end of 2023. The report showed increased research and development expenses, primarily due to clinical and regulatory activities, as well as heightened general and administrative expenses linked to commercialization efforts. Despite these costs, the company remains focused on its strategic goals.
Looking ahead, Applied Therapeutics anticipates crucial regulatory decisions that could pave the way for govorestat to become its first commercial product. The management remains optimistic about the therapy’s potential to address the underlying mechanisms of the targeted diseases, marking a significant step forward in 2025.