Applied Therapeutics 2025 Q3 Earnings 72.3% Net Loss Reduction Beats Expectations

Applied Therapeutics (NASDAQ: APLT) delivered a strong earnings beat, narrowing its net loss by 72.3% year-over-year while exceeding revenue forecasts. The company reported a $19.0M net loss for Q3 2025, compared to $68.59M in 2024, with GAAP EPS of -$0.13, $0.01 above estimates. Management outlined a revised guidance projecting cash runway through 2026, pending regulatory milestones.

Revenue

The company’s total revenue surged 719.7% to $1.0 million in Q3 2025, driven entirely by license revenue from its Biossil Agreement. This marked a significant improvement from $122,000 in the prior-year period, reflecting successful execution of its out-licensing strategy.

Earnings/Net Income

Applied Therapeutics narrowed its net loss to $18.99 million in Q3 2025, a 72.3% reduction from $68.59 million in Q3 2024. Earnings per share improved to -$0.13 from -$0.48, representing a 72.9% per-share loss reduction. The EPS beat highlights improved operational efficiency despite ongoing R&D investments.

Post-Earnings Price Action Review

The strategy of purchasing APLT shares on its revenue announcement date and holding for 30 days generated a 17.65% cumulative return, albeit with an 11.82% maximum drawdown. This outperformance, though modest, underscored short-term positive momentum amid biotech sector volatility. However, recent price action has been bearish, with shares plummeting 51.38% in a single trading day and 76.52% month-to-date, reflecting broader market skepticism.

CEO Commentary

Interim CEO Les Funtleyder emphasized progress in regulatory alignment for govorestat across CMT-SORD, Classic Galactosemia, and PMM2-CDG. Despite cash balances falling to $11.9M, R&D expenses dropped 35% to $9.6M, demonstrating cost discipline. The company remains focused on resolving FDA feedback for CMT-SORD and advancing its NDA resubmission strategy for Classic Galactosemia.

Guidance

The company expects to submit a second Type C meeting request with the FDA for CMT-SORD to finalize Phase 3 trial design, with no immediate NDA pathway decision. A Q4 2025 FDA meeting for Classic Galactosemia is confirmed, while PMM2-CDG development continues based on positive safety data. Cash is projected to support operations through 2026, contingent on regulatory and clinical progress.

Additional News

Recent regulatory updates include a constructive Type C meeting with the FDA for CMT-SORD and a scheduled Q4 2025 meeting to address 2024 NDA rejections for Classic Galactosemia. New clinical data for govorestat in PMM2-CDG showed a 46% improvement in the NPCRS score, supporting continued development. Leadership changes, including the resignation of Executive Chairman John Johnson, and a strategic pivot toward cost optimization further underscore the company’s focus on long-term value creation.