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WebsiteApplied Therapeutics Inc (APLT): Company Profile and Developments
Applied Therapeutics Inc is a clinical-stage biopharmaceutical company focused on developing treatments for rare diseases with high unmet medical need. Headquartered in New York, New York, the firm employs a technology-driven approach—leveraging advanced crystallography, biomarker guidance, and established clinical endpoints—to facilitate the progression of its drug candidates through development and regulatory approval.
Corporate Structure and Leadership
With approximately 11–50 employees, Applied Therapeutics maintains a compact organizational structure. Key executives and contributors include:
- Constantine Chinoporos, Corporate Development Executive, specializing in biopharma licensing and mergers & acquisitions
- Reena Thomas Colacot, Senior Scientist
- Kimberly Gutek Cox, Operations Executive, responsible for supply chain and manufacturing strategies
- Andrew Wasmuth, Vice President of Chemistry, Manufacturing and Formulation
This team supports a pipeline focused on aldose reductase inhibitors (ARIs) aimed at targeting enzymes implicated in various rare metabolic disorders.
Biopharmaceuticals by little plant
Recent Developments and News
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Stock Performance (2025-09-26)
• Ticker: APLT (Nasdaq Capital Market)
• Last Price: $0.7219 (up 28.86% intraday)
• Volume: 2,967,292 shares -
Phase II/III INSPIRE Trial (September 2025)
Applied Therapeutics announced that govorestat, its lead ARI candidate for sorbitol dehydrogenase deficiency (a subtype of Charcot-Marie-Tooth disease), did not meet the trial’s primary endpoint (10-meter walk-run test) after 12 months of treatment. The company reported positive secondary and patient-reported outcomes, and indicated plans to pursue a new drug application (NDA) submission in 2025. -
FDA Interaction (December 2024)
The FDA issued a refusal to file for govorestat in galactosemia, citing application deficiencies. Applied has engaged with the agency to address these concerns. -
Equity Offering (August 29, 2025)
Through a Controlled Equity Offering Sales Agreement with Cantor Fitzgerald, Applied authorized the sale of up to $75 million in common stock. Cantor Fitzgerald will act as sales agent, with a commission of 3.0% on gross proceeds. -
Institutional Ownership Update (August 14, 2025)
T. Rowe Price Investment Management reported beneficial ownership of 18,683,990 shares, representing approximately 13.2% of outstanding shares, indicating institutional interest in Applied’s pipeline.
Financial and Strategic Analysis
As of the latest reports, Applied Therapeutics’ market capitalization is approximately $63 million, with an enterprise value near $36 million. Key financial metrics for the trailing twelve months include:
| Metric | Value |
|---|---|
| Revenue | $121,000 |
| Net Income | –$67.74 million |
| Total Cash (most recent quarter) | $30.4 million |
| Total Debt/Equity (most recent quarter) | 14.92% |
| Price/Sales (trailing twelve months) | 531.5Ă— |
| Price/Book (most recent quarter) | 3.67Ă— |
The elevated price-to-sales ratio reflects the company’s status as a pre-revenue, clinical-stage entity. Recent equity offerings aim to extend the company's financial runway and support ongoing trials and potential NDA filings. The strategy of targeting rare-disease pathways with well-defined biomarker endpoints may facilitate regulatory feedback.
Market Position and Industry Context
In the biotechnology research sector, Applied Therapeutics competes with small to mid-cap firms developing therapies for rare diseases. Its focus on aldose reductase—which is associated with several inherited metabolic disorders—enables the company to pursue a product franchise approach (including indications such as galactosemia, SORD deficiency, PMM2-CDG, and diabetic retinopathy). However, regulatory challenges and the requirement for considerable capital infusions are ongoing considerations.
tl;dr
As of September 26, 2025, APLT shares increased by 28.86% to $0.7219 while executing a $75 million at-the-market equity offering with Cantor Fitzgerald. Govorestat did not meet the primary endpoint in its Phase II/III INSPIRE trial for CMT-SORD in September 2025, though secondary and patient-reported outcomes showed beneficial results. The company plans an NDA submission for govorestat in 2025 and is actively engaging the FDA regarding the prior galactosemia application rejection. Institutional investors, including T. Rowe Price, hold significant stakes in the company, reflecting interest in its rare-disease pipeline and financing strategy.
