Applied Therapeutics 2025 Q3 Earnings Narrowed Losses by 72.3%

Applied Therapeutics (NASDAQ: APLT) reported Q3 2025 results, surpassing revenue expectations and narrowing losses significantly. The company’s 719.7% revenue growth and 72.3% reduction in net loss highlight progress, though regulatory challenges persist. Management emphasized strategic FDA engagements and operational efficiency.

Revenue

Total revenue surged to $1 million in Q3 2025, a 719.7% increase from $122,000 in Q3 2024. License revenue accounted for the entire $1 million, reflecting strong performance in its core segment. This marked improvement underscores the company’s ability to generate revenue despite its early-stage development focus.

Earnings/Net Income

Applied Therapeutics narrowed its net loss to $18.99 million (EPS -$0.13) in Q3 2025, a 72.3% reduction from $68.59 million (EPS -$0.48) in Q3 2024. While losses persist, the significant improvement indicates progress in cost management and operational efficiency, aligning with the company’s focus on regulatory milestones.

Post-Earnings Price Action Review

The strategy of buying APLT shares on the revenue announcement date and holding for 30 days yielded a 20% return, reflecting biotech sector volatility. However, November 2024 saw a 30% drawdown post-Q3 report, driven by broader market concerns and regulatory uncertainties around govorestat’s CMT-SORD pathway. Despite these challenges, APLT’s proactive FDA engagement and robust safety profile for govorestat signal strategic resilience. Negative margins and a distressed Altman Z-Score, however, underscore inherent risks for investors. Sector-specific risks, including drug development and regulatory approval dependencies, remain critical for the stock’s trajectory.

CEO Commentary

Les Funtleyder, interim CEO and CFO, highlighted constructive FDA discussions post-Type C meeting for CMT-SORD and plans to submit a new meeting request for Phase 3 trial design. He emphasized govorestat’s safety profile in long-term trials and upcoming Q4 2025 FDA meetings for Classic Galactosemia and PMM2-CDG. The tone balanced regulatory challenges with strategic momentum.

Guidance

The company plans to submit a Type C meeting request for CMT-SORD Phase 3 design and a Q4 2025 meeting for Classic Galactosemia. Financially, APLT reported $11.9 million in cash as of September 30, 2025, with ongoing cost reductions and a focus on capital efficiency.

Additional News

1. FDA Regulatory Milestones: A Q4 2025 meeting is scheduled to review govorestat for Classic Galactosemia, following a 2024 Complete Response Letter.

2. Leadership Transition: Executive Chairman John Johnson resigned in November 2025 for personal reasons, signaling corporate governance changes.

3. Clinical Data Publication: New PMM2-CDG data on govorestat was published in JIMD and presented at ASHG 2025, reinforcing its long-term safety and development potential.