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Mar 31
Applied Therapeutics Q1 2025 Earnings Report
Applied Therapeutics reported its financial results for the first quarter ended March 31, 2025, showing a net loss and decreased cash reserves.
Key Takeaways
Applied Therapeutics reported a net loss of $21.8 million for the first quarter of 2025, with total revenue at $0. Cash and cash equivalents decreased to $50.8 million. The company is focused on advancing govorestat programs and preparing for regulatory interactions.
Net loss for Q1 2025 was $21.8 million, or $0.15 per basic and diluted common share.
Cash and cash equivalents and short-term investments totaled $50.8 million as of March 31, 2025.
Research and development expenses decreased to $7.8 million in Q1 2025 from $12.2 million in Q1 2024.
General and administrative expenses increased to $17.7 million in Q1 2025 from $9.1 million in Q1 2024.
Applied Therapeutics
Applied Therapeutics
Forward Guidance
The company continues to focus on advancing govorestat for CMT-SORD Deficiency and Classic Galactosemia, including preparing for regulatory interactions and addressing the Complete Response Letter from the FDA.
Positive Outlook
- Full 12-month clinical data and new topline 18-month and 24-month data from INSPIRE Phase 3 trial of govorestat in CMT-SORD Deficiency to be presented at PNS 2025 Annual Meeting.
- Continued focus on advancing govorestat across multiple indications.
- Confidence in govorestat's potential to address high unmet needs in rare diseases.
- Preparation for potential future regulatory interactions for both CMT-SORD and Classic Galactosemia.
- Ongoing work to provide FDA with support for potential use of accelerated approval pathway for CMT-SORD Deficiency.
Challenges Ahead
- Addressing issues in the Complete Response Letter (CRL) from the FDA for govorestat for Classic Galactosemia.
- Uncertainty regarding the timing of any potential FDA meetings, interactions or submissions.
- Substantial risks and uncertainties that could cause actual results to differ materially from forward-looking statements.
- No assurance that plans, intentions, expectations or strategies will be attained or achieved.
- The need to successfully acquire or license additional product candidates on reasonable terms and advance them into clinical studies.