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Sep 30, 2022
Applied Therapeutics Q3 2022 Earnings Report
Reported financial results for the third quarter ended September 30, 2022.
Key Takeaways
Applied Therapeutics reported on their progress across all three late-stage programs, focusing on completing Phase 3 trials in Galactosemia, SORD Deficiency, and Diabetic Cardiomyopathy. They anticipate sharing data in 2023, which could lead to new treatment options for patients with limited or no available therapies.
Made significant progress across all three late-stage programs.
Focused on successful completion of Phase 3 trials in Galactosemia, SORD Deficiency and Diabetic Cardiomyopathy.
Anticipate sharing data in 2023.
Potential to bring new treatment options to patients with limited to no available therapies.
Applied Therapeutics
Applied Therapeutics
Forward Guidance
The company provided forward-looking statements regarding the timing of topline data, plans to submit for potential regulatory approval, and plans to meet with the EMA to discuss conditional approval.
Positive Outlook
- Timing of topline data is expected around year-end 2023 or early 2024.
- Plans to submit for potential regulatory approval.
- Plans to meet with the EMA to discuss conditional approval.
Challenges Ahead
- Plans to develop, market and commercialize product candidates.
- The initiation, timing, progress and results of current and future preclinical studies and clinical trials and research and development programs.
- Ability to take advantage of expedited regulatory pathways for any of 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 and advance product candidates into, and successfully complete, clinical studies.