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Mar 31, 2022
Applied Therapeutics Q1 2022 Earnings Report
Reported financial results for the first quarter ended March 31, 2022.
Key Takeaways
Applied Therapeutics reported financial results for the first quarter ended March 31, 2022, with continued progress in three Phase 3 trials and multiple clinical milestones expected in 2022.
Made significant progress in the first quarter across all three of Phase 3 programs.
Reached alignment with the FDA on Galactosemia.
Excited about the expected milestones in the year ahead.
Developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need.
Applied Therapeutics
Applied Therapeutics
Forward Guidance
This press release contains forward-looking statements that involve substantial risks and uncertainties.
Positive Outlook
- NDA submission for potential approval of AT-007.
- Timing of the completion of our the statistical analysis of clinical outcomes.
- Timing of expected milestones.
- Likelihood that data from our clinical trials will support future development of our product candidates.
- Likelihood of obtaining regulatory approval of our product candidates.
Challenges Ahead
- Plans to develop and commercialize our product candidates.
- The initiation, timing, progress and results of our current and future preclinical studies and clinical trials and our research and development programs.
- Ability to take advantage of expedited regulatory pathways for any of our product candidates.
- Estimates regarding expenses, future revenue, capital requirements and needs for additional financing.
- Ability to successfully acquire or license additional product candidates on reasonable terms.