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Dec 31, 2023
Applied Therapeutics Q4 2023 Earnings Report
Reported financial results for the fourth quarter and full year ended December 31, 2023.
Key Takeaways
Applied Therapeutics reported fourth quarter and full year financial results, highlighting clinical and regulatory progress with govorestat for Galactosemia, including NDA acceptance and MAA validation. Positive data from the INSPIRE study in SORD Deficiency was announced, and the company plans to request a pre-NDA meeting with the FDA. A $100 million private placement strengthened the balance sheet, extending the cash runway into 2026.
NDA for govorestat accepted and granted Priority Review by FDA for the treatment of Classic Galactosemia.
MAA under review by EMA with decision expected in 4Q 2024.
Announced positive results from 12-month interim analysis of govorestat in ongoing INSPIRE Phase 3 trial in SORD Deficiency.
Strengthened balance sheet with $100 million Private Placement, expected to extend cash runway into 2026.
Applied Therapeutics
Applied Therapeutics
Forward Guidance
The company's cash and cash equivalents are expected to extend into 2026, with plans to request a pre-NDA meeting with the FDA. The company's ongoing NDA and MMA submissions may be approved.
Positive Outlook
- Company’s expectation that its cash and cash equivalents will extend into 2026
- Company’s plans to request a pre-NDA meeting with the FDA
- The likelihood that the Company’s ongoing NDA and MMA submissions will be approved
- Plans to develop, market and commercialize product candidates
- Ability to successfully acquire or license additional product candidates on reasonable terms and advance product candidates into, and successfully complete, clinical studies
Challenges Ahead
- Plans to develop, market 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 and advance product candidates into, and successfully complete, clinical studies
- Ability to maintain and establish collaborations or obtain additional funding