Applied Therapeutics reported third‑quarter 2025 results that included $1 million in revenue and a net loss of $19 million, or $0.13 per share, compared with analyst expectations of a $0.14 loss. The company’s revenue beat consensus by $584,000, driven almost entirely by a $1 million license‑income increase that more than doubled the $122,000 earned in the same quarter a year earlier.
The quarter’s loss narrowed from the $68.6 million loss reported in Q3 2024, a reduction of $49.6 million. The improvement was largely the result of disciplined cost management: research and development expenses fell to $9.6 million from $14.8 million, and general and administrative costs dropped to $8.2 million from $15.0 million. These savings offset a modest rise in legal and litigation expenses and an insurance‑related recovery.
Cash and cash equivalents stood at $11.9 million as of September 30, a sharp decline from $79.4 million at the end of 2024. Management acknowledged that the company faces “substantial doubt” about its ability to continue as a going concern within one year, underscoring the urgency of securing additional financing or a strategic partnership.
Regulatory progress remained a central focus. A meeting with the FDA was held to discuss a potential NDA submission for govorestat in Charcot‑Marie‑Tooth Sorbitol Dehydrogenase Deficiency (CMT‑SORD); the company is awaiting meeting minutes to determine the next steps. A separate FDA meeting is scheduled for Q4 2025 to review govorestat for classic galactosemia, following a prior complete response letter and warning letter issued in November 2024. In addition, new data from a single patient with PMM2‑CDG, published in the Journal of Inherited Metabolic Disease and presented at the 2025 ASHG Annual Meeting, was highlighted as a potential development opportunity.
Interim CEO and CFO Les Funtleyder emphasized that the company is “focused on operational execution and regulatory progress.” He noted that the firm has “completed a meeting with the FDA to discuss a potential NDA submission for govorestat for the treatment of CMT‑SORD” and that it is “scheduled to meet with the FDA in the fourth quarter to review govorestat for classic galactosemia.” Funtleyder also highlighted the PMM2‑CDG data as encouraging, stating it “further supports the potential for continued clinical development in this indication of high unmet need.” The company’s guidance for the remainder of the year remains unchanged, reflecting cautious optimism amid regulatory uncertainty and liquidity constraints.
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