Applied Therapeutics reported a Q3 2025 net loss of $19.0 million, or $0.13 per share, a beat of $0.01 against the consensus estimate of $0.14 per share. Revenue rose to $1.0 million, surpassing the $416.7 k consensus and reflecting a 700 % year‑over‑year increase driven by a modest uptick in sales of its investigational product, govorestat, in the rare‑disease pipeline. The earnings beat is largely attributable to disciplined cost management: R&D expenses fell to $9.6 million from $14.8 million in Q3 2024, while G&A costs remained flat, allowing the company to offset the loss from a one‑time restructuring charge that was not present in the prior year.
Cash and cash equivalents stood at $11.9 million as of September 30 2025, a steep decline from $79.4 million at the end of 2024. The rapid erosion of liquidity underscores a high burn rate and signals that the company will need additional financing to sustain its clinical program and regulatory activities. Management has acknowledged the cash constraint, noting that the company’s “substantial doubt about its ability to continue as a going concern” remains a priority for the coming quarters.
Regulatory progress for govorestat continued across multiple indications. A Type C meeting with the FDA in Q3 2025 focused on the design of a potential Phase 3 trial for Charcot‑Marie‑Tooth Sorbitol Dehydrogenase Deficiency (CMT‑SORD). A separate meeting is scheduled for Q4 2025 to review govorestat for Classic Galactosemia, following a Complete Response Letter and warning letter issued in November 2024. In addition, data from a single‑patient trial of govorestat for phosphomannomutase 2 congenital disorder of glycosylation (PMM2‑CDG) were published in the Journal of Inherited Metabolic Disease and presented at the 2025 ASHG Annual Meeting, adding a new indication to the company’s pipeline.
The company also announced a transition in its Board of Directors. Executive Chairman John Johnson resigned for personal reasons, a change that may signal a shift in governance and strategic focus as the company navigates its regulatory and financial challenges.
Les Funtleyder, interim CEO and CFO, said, “We expect to submit another meeting request with the FDA to further discuss the design of a potential Phase 3 trial. We remain dedicated to advancing the development of govorestat for CMT‑SORD patients and look forward to continued partnership with the FDA.” He added that the scheduled Q4 meeting for Classic Galactosemia and the PMM2‑CDG data publication demonstrate the company’s commitment to expanding its rare‑disease portfolio.
The company’s earnings beat and revenue growth are tempered by a sharp decline in cash and ongoing regulatory hurdles. Historically, Applied Therapeutics’ stock has been highly sensitive to FDA interactions, with significant volatility following meetings and regulatory decisions. The current results suggest that while the company is making progress on its pipeline, it remains under pressure to secure additional funding and to navigate the complex regulatory landscape for its lead product, govorestat.
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