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Mar 31, 2021
Applied Therapeutics Q1 2021 Earnings Report
Reported financial results for the first quarter ended March 31, 2021.
Key Takeaways
Applied Therapeutics reported its Q1 2021 financial results, highlighting the progression of late-stage programs towards commercialization in Galactosemia and Diabetic Cardiomyopathy, and advancement of rare disease programs in SORD and PMM2-CDG. The company ended the quarter with $148.1 million in cash and cash equivalents and short-term investments.
Phase 2 pilot study of AT-007 initiated in patients with SORD Deficiency.
NDA submission for AT-007 in Galactosemia expected no later than Q3 2021; commercial preparations ongoing.
Completion of enrollment in ARISE-HF Phase 3 global registrational study of AT-001 in Diabetic Cardiomyopathy on track for mid-2021.
Ended 1Q21 with a strong balance sheet of $148.1 million in cash and cash equivalents and short-term investments.
Applied Therapeutics
Applied Therapeutics
Forward Guidance
The press release contains forward-looking statements regarding the timing of NDA submission for AT-007, rare disease franchise expansion programs, clinical trials, and regulatory approval of product candidates.
Positive Outlook
- Timing of NDA submission for potential approval of AT-007, which will include data from the ACTION-Galactosemia Kids trial and the 90-day safety data in adults with Galactosemia
- Timing of rare disease franchise expansion programs in SORD Deficiency and PMM2-CDG
- Timing of the initiation and completion of clinical trials
- Likelihood that data from clinical trials will support future development of product candidates
- Likelihood of obtaining regulatory approval of product candidates
Challenges Ahead
- Plans to develop 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