Loading...
•
Dec 31, 2021
Applied Therapeutics Q4 2021 Earnings Report
Reported financial results for the fourth quarter and full year ended December 31, 2021.
Key Takeaways
Applied Therapeutics reported financial results for the fourth quarter and full year ended December 31, 2021, highlighting progress in three Phase 3 trials and expectations for multiple clinical and regulatory milestones in 2022.
Company remains committed to bringing new treatments to patients in areas of high unmet need.
Advancing treatments forward with three ongoing Phase 3 studies across Galactosemia, Sorbitol Dehydrogenase (SORD) Deficiency and Diabetic Cardiomyopathy.
Expecting multiple catalysts and opportunities for value creation in 2022 and 2023.
Lead drug candidate, AT-007, is a novel central nervous system penetrant Aldose Reductase Inhibitor (ARI) for the treatment of CNS rare metabolic diseases.
Applied Therapeutics
Applied Therapeutics
Forward Guidance
The company provided forward-looking statements regarding the timing of NDA submission, expectations for catalysts and value creation, timing of clinical trial completion and statistical analysis, the likelihood of data supporting product development, and the likelihood of regulatory approval.
Positive Outlook
- Timing of NDA submission for potential approval of AT-007.
- Expectations regarding catalysts and opportunities for value creation in 2022 and 2023.
- Timing of the completion of the statistical analysis of the 6 month clinical outcomes.
- Timing of the initiation and completion of our clinical trials.
- Likelihood that data from our clinical trials will support future development 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.
- Estimates regarding expenses, future revenue, capital requirements and needs for additional financing.
- Ability to successfully acquire or license additional product candidates on reasonable terms.
- Impact of the COVID-19 pandemic on the timing and progress of ongoing clinical trials and business in general.